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Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?

18 de enero de 2018 actualizado por: Philippe VAN DER LINDEN, Brugmann University Hospital

General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used.

The functional residual capacity (FRC) of obese patients during general anesthesia is even smaller than the one of healthy patients. There is a direct relationship between the body mass index and the decrease of the functional residual capacity. Obese patients have therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will increase the decrease of the CRF, and thus aggravate the formation of these atelectasis.

Atelectasis affect the peroperative gas exchanges and are likely to be involved in the worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance of secretions and the lymph flow, which predispose to lung infections.Taking all these factors into account, it is logical to think that the atelectasis presence can lead to an increase of the postsurgical morbidity (respiratory distress, infections). That is why actively fighting against the formation of these atelectasis is important.

There is a lack of scientific evidence to say that the strategies against atelectasis as PEEP have a significant impact on the patient's postoperative status. The expected clinical benefits balance (reduction of respiratory distress episodes, infections and mortality) versus the risks linked to the maneuvers done to reduce the development of atelectasis (barotraumas, cardiac complications) remains to be determined.

The primary goal of this study is to evaluate the impact of two different alveolar recruitment strategies on the incidence of postoperative hypoxemia in obese patients after bariatric surgery.

The secondary objectives of this study are to compare the number of recruitment maneuvers, the Pa02 / FI02 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen), the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2 gradient (arterial and end tidal gradient) between two alveolar recruitment strategies applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy).

The tertiary objectives of this study are to report the number of respiratory complications and postoperative wound infections at the 30th postoperative day.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used.

These atelectasis are formed on one hand by the reduction of the functional residual capacity (FRC) following a compression mechanism (loss of the inspiratory muscle tone, which is accompanied by a chest wall configuration change and a diaphragm cephalic movement) and on the other hand by a denitrogenation absorption process (ventilation at high Fi02 (oxygen inspired fraction) causing complete absorption of O2 with lack of support for the alveolus, which then collapses).

The FRC of obese patients during general anesthesia is even smaller than the one of healthy patients. There is a direct relationship between the body mass index and the decrease of the functional residual capacity. Obese patients have therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will increase the decrease of the CRF, and thus aggravate the formation of these atelectasis.

Atelectasis affect the peroperative gas exchanges and are likely to be involved in the worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance of secretions and the lymph flow, which predispose to lung infections.Taking all these factors into account, it is logical to think that the atelectasis presence can lead to an increase of the postsurgical morbidity (respiratory distress, infections). That is why actively fighting against the formation of these atelectasis is important.

Several strategies have been studied in order to improve respiratory mechanics and reduce impaired gas exchange during laparoscopic surgery in obese patients. The position called "chair", mechanical ventilation with PEEP, recruitment maneuvers followed by the PEEP, and spontaneous ventilation with CPAP before extubation, are all strategies that have proven effective to decrease development these atelectasis.

Currently, the scientific community agrees on the fact that PEEP improves intraoperative respiratory function (improved compliance, oxygenation) especially in conjunction with recruitment maneuvers.

But there is a lack of scientific evidence to say that the strategies against atelectasis as PEEP have a significant impact on the patient's postoperative status. The expected clinical benefits balance (reduction of respiratory distress episodes, infections and mortality) versus the risks linked to the maneuvers done to reduce the development of atelectasis (barotraumas, cardiac complications) remains to be determined.

The primary goal of this study is to evaluate the impact of two different alveolar recruitment strategies on the incidence of postoperative hypoxemia in obese patients after bariatric surgery.

The secondary objectives of this study are to compare the number of recruitment maneuvers, the Pa02 / FI02 ratio, the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2 gradient between two alveolar recruitment strategies applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy).

The tertiary objectives of this study are to report the number of respiratory complications and postoperative wound infections at the 30th postoperative day.

Tipo de estudio

Intervencionista

Inscripción (Actual)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Brussels, Bélgica, 1020
        • CHU Brugmann

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • ASA score (American Society of Anesthesiologists ) of II or III
  • BMI > 35 kg/m²
  • Elective laparoscopic bariatric surgery: gastric bypass or sleeve

Exclusion Criteria:

  • Restrictive (CPT <65%) or obstructive (VEMS/CV < 69%) chronic lung disease
  • Increase of the intracranial pressure
  • History of smoking with chronic obstructive disease (VEMS/CV)
  • Active tabagism
  • Ongoing pregnancy
  • History of heart failure (NYHA III or IV) or coronary artery disease
  • Urgent surgery
  • Allergy to a drug used within the study
  • Lack of written informed consent

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: PEEP 10 cmH20
In this group, a PEEP of 10 cmH20 is applied for the duration of the intervention and a recruitment maneuver is applied each time the SpO2 (oxygen pulsated saturation) drops below 95%.
Comparador activo: optimal PEEP
In this group, 10 cmH20 PEEP is applied immediately. Then the "optimal PEEP" is sought at three key moments. It is determined by the best value of lung compliance found in the patient. It is sought by increasing or decreasing the value of the PEEP by increments or decrements of 2 cmH20. If after 6 respiratory cycles, the value of the compliance is increased, the investigator continues to increase the value of the PEEP. On the other hand, if the value of compliance is reduced, the investigator reduces the value of PEEP. The value of the PEEP selected shall in no event exceed the set pressure range (maximum pressure plate of 30 cmH20 and maximum inspiratory peak pressure 40cmH20). A recruitment maneuver is applied each time the SpO2 drops below 95%, as in the PEEP 10cmH2O group.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of hypoxemia episodes (Sp02<90%)
Periodo de tiempo: continuously during 48h after surgery
This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<90%) and their duration in obese patients, in the postoperative period.
continuously during 48h after surgery
Number of hypoxemia episodes (Sp02<95%)
Periodo de tiempo: continuously during 48h after surgery
This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<95%) and their duration in obese patients, in the postoperative period.
continuously during 48h after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of recruitment manoeuvers
Periodo de tiempo: From the beginning of the surgery till moment 1 (after induction/intubation, patient laying flat, without pneumoperitoneum)
Recruitment manoeuver are performed if patient saturation drops below 95%.
From the beginning of the surgery till moment 1 (after induction/intubation, patient laying flat, without pneumoperitoneum)
Number of recruitment manoeuvers
Periodo de tiempo: From moment 1 till moment 2 (after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation)
Recruitment manoeuver are performed if patient saturation drops below 95%.
From moment 1 till moment 2 (after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation)
Number of recruitment manoeuvers
Periodo de tiempo: From moment 2 till moment 3 (after pneumoperitoneum exsufflation - patient lying flat)
Recruitment manoeuver are performed if patient saturation drops below 95%.
From moment 2 till moment 3 (after pneumoperitoneum exsufflation - patient lying flat)
Number of recruitment manoeuvers
Periodo de tiempo: From moment 3 till the end of the surgery (patient leaving the theater)
Recruitment manoeuver are performed if patient saturation drops below 95%.
From moment 3 till the end of the surgery (patient leaving the theater)
Pulmonary dynamic compliance (Cd) - preoperative
Periodo de tiempo: Just before surgery, at ambient air contact
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Just before surgery, at ambient air contact
Pulmonary dynamic compliance (Cd) - moment 1
Periodo de tiempo: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
Pulmonary dynamic compliance (Cd) -moment 2
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Pulmonary dynamic compliance (Cd) -moment 3
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
just after pneumoperitoneum exsufflation - patient lying flat
Pulmonary dynamic compliance (Cd) -if recruitment manoeuvers
Periodo de tiempo: Five minutes after any recruitment manoeuver
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Five minutes after any recruitment manoeuver
Anatomic dead space - preoperative
Periodo de tiempo: Just before surgery, at ambient air contact
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Just before surgery, at ambient air contact
Anatomic dead space -moment 1
Periodo de tiempo: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
Anatomic dead space -moment 2
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Anatomic dead space -moment 3
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
just after pneumoperitoneum exsufflation - patient lying flat
Anatomic dead space -if recruitment manoeuvers
Periodo de tiempo: Five minutes after any recruitment manoeuver
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Five minutes after any recruitment manoeuver
PaO2/FiO2 ratio - preoperative
Periodo de tiempo: Just before surgery, at ambient air contact
Arterial oxygen partial pressure to fractional inspired oxygen ratio
Just before surgery, at ambient air contact
PaO2/FiO2 ratio - moment 1
Periodo de tiempo: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
Arterial oxygen partial pressure to fractional inspired oxygen ratio
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
PaO2/FiO2 ratio - moment 2
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Arterial oxygen partial pressure to fractional inspired oxygen ratio
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
PaO2/FiO2 ratio - moment 3
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
Arterial oxygen partial pressure to fractional inspired oxygen ratio
just after pneumoperitoneum exsufflation - patient lying flat
PaO2/FiO2 ratio - if recruitment manoeuvers
Periodo de tiempo: Five minutes after any recruitment manoeuver
Arterial oxygen partial pressure to fractional inspired oxygen ratio
Five minutes after any recruitment manoeuver
PaCO2-EtCO2 gradient - preoperative
Periodo de tiempo: Just before surgery, at ambient air contact
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
Just before surgery, at ambient air contact
PaCO2-EtCO2 gradient - moment 1
Periodo de tiempo: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
PaCO2-EtCO2 gradient - moment 2
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
PaCO2-EtCO2 gradient - moment 3
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
just after pneumoperitoneum exsufflation - patient lying flat
PaCO2-EtCO2 gradient - if recruitment manoeuvers
Periodo de tiempo: Five minutes after any recruitment manoeuver
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
Five minutes after any recruitment manoeuver
Number of respiratory complications
Periodo de tiempo: 30 days after surgery
Number of hospitalisations due to respiratory complications within 30 days after surgery.
30 days after surgery
Number of postoperative wound infections
Periodo de tiempo: 30 days after surgery
All patients are seen at the surgical consultation on day 30 after surgery. The anamnesis performed during that consultation enables the investigators to identify patients with wound infections (defined as a need for local or oral antibiotics, additional hospitalisation or abnormal cicatrisation).
30 days after surgery
Pre-operative physiologic measures: cardiac frequency (FC)
Periodo de tiempo: Just before surgery, at ambient air contact
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Just before surgery, at ambient air contact
Pre-operative physiologic measures: Arterial tension (TA)
Periodo de tiempo: Just before surgery, at ambient air contact
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Just before surgery, at ambient air contact
Pre-operative physiologic measures: pH
Periodo de tiempo: Just before surgery, at ambient air contact
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Just before surgery, at ambient air contact
Pre-operative physiologic measures: partial pressure of carbon dioxide in the arterial blood (PaCO2)
Periodo de tiempo: Just before surgery, at ambient air contact
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens).
Just before surgery, at ambient air contact
Operative physiologic measures - moment 1: FC
Periodo de tiempo: just after induction/intubation, patient laying flat, without pneumoperitoneum
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
just after induction/intubation, patient laying flat, without pneumoperitoneum
Operative physiologic measures - moment 1: PAM (Average arterial pressure)
Periodo de tiempo: just after induction/intubation, patient laying flat, without pneumoperitoneum
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
just after induction/intubation, patient laying flat, without pneumoperitoneum
Operative physiologic measures - moment 1: pH
Periodo de tiempo: just after induction/intubation, patient laying flat, without pneumoperitoneum
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
just after induction/intubation, patient laying flat, without pneumoperitoneum
Operative physiologic measures - moment 1: PaCO2
Periodo de tiempo: just after induction/intubation, patient laying flat, without pneumoperitoneum
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after induction/intubation, patient laying flat, without pneumoperitoneum
Operative physiologic measures - moment 1: CO2
Periodo de tiempo: just after induction/intubation, patient laying flat, without pneumoperitoneum
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after induction/intubation, patient laying flat, without pneumoperitoneum
Operative physiologic measures - moment 2: FC
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Operative physiologic measures - moment 2: PAM
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Operative physiologic measures - moment 2: pH
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Operative physiologic measures - moment 2: PaCO2
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Operative physiologic measures - moment 2: CO2
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Operative physiologic measures - moment 3: FC
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
just after pneumoperitoneum exsufflation - patient lying flat
Operative physiologic measures - moment 3: PAM
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
just after pneumoperitoneum exsufflation - patient lying flat
Operative physiologic measures - moment 3: pH
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
just after pneumoperitoneum exsufflation - patient lying flat
Operative physiologic measures - moment 3: CO2
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after pneumoperitoneum exsufflation - patient lying flat
Operative physiologic measures - moment 3: PaCO2
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after pneumoperitoneum exsufflation - patient lying flat
Operative physiologic measures - if recruitment manoeuvers occurs: FC
Periodo de tiempo: Five minutes after any recruitment manoeuver
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Five minutes after any recruitment manoeuver
Operative physiologic measures - if recruitment manoeuvers occurs: PAM
Periodo de tiempo: Five minutes after any recruitment manoeuver
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Five minutes after any recruitment manoeuver
Operative physiologic measures - if recruitment manoeuvers occurs: SpO2
Periodo de tiempo: Five minutes after any recruitment manoeuver
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Five minutes after any recruitment manoeuver
Operative physiologic measures - if recruitment manoeuvers occurs: pH
Periodo de tiempo: Five minutes after any recruitment manoeuver
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Five minutes after any recruitment manoeuver
Operative physiologic measures - if recruitment manoeuvers occurs: PaCO2
Periodo de tiempo: Five minutes after any recruitment manoeuver
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Five minutes after any recruitment manoeuver
Operative physiologic measures - if recruitment manoeuvers occurs: PaO2
Periodo de tiempo: Five minutes after any recruitment manoeuver
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Five minutes after any recruitment manoeuver
Operative physiologic measures - if recruitment manoeuvers occurs: CO2
Periodo de tiempo: Five minutes after any recruitment manoeuver
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Five minutes after any recruitment manoeuver
Pre-operative physiologic measures: partial pressure of oxygen in the arterial blood (PaO2)
Periodo de tiempo: Just before surgery, at ambient air contact
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Just before surgery, at ambient air contact
Operative physiologic measures - moment 1: PaO2
Periodo de tiempo: just after induction/intubation, patient laying flat, without pneumoperitoneum
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after induction/intubation, patient laying flat, without pneumoperitoneum
Operative physiologic measures - moment 2: PaO2
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Operative physiologic measures - moment 3: PaO2
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after pneumoperitoneum exsufflation - patient lying flat
Pre-operative physiologic measures: Oxygen Pulsated Saturation (SpO2)
Periodo de tiempo: Just before surgery, at ambient air contact
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Just before surgery, at ambient air contact
Operative physiologic measures - moment 1: SpO2
Periodo de tiempo: just after induction/intubation, patient laying flat, without pneumoperitoneum
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after induction/intubation, patient laying flat, without pneumoperitoneum
Operative physiologic measures - moment 2: SpO2
Periodo de tiempo: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
Operative physiologic measures - moment 3: SpO2
Periodo de tiempo: just after pneumoperitoneum exsufflation - patient lying flat
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
just after pneumoperitoneum exsufflation - patient lying flat

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Van Hecke Delphine, MD, CHU Brugmann

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2013

Finalización primaria (Actual)

1 de diciembre de 2015

Finalización del estudio (Actual)

1 de marzo de 2016

Fechas de registro del estudio

Enviado por primera vez

12 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

16 de octubre de 2015

Publicado por primera vez (Estimar)

20 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de enero de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

18 de enero de 2018

Última verificación

1 de enero de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CHUB-CRF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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