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THRIVE Ventilation for Operative Hysteroscopy Under General Anesthesia

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Apnoeic Ventilation During Operative Hysteroscopic Procedures Under General Anesthesia: an Observational Study.

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min in order to maintain viable gas exchange during an extended period of cessation of spontaneous ventilation.

This technique has been successfully applied in several clinical settings (induction of general anesthesia, laryngoscopy in predicted difficult airway management, and as unique airway management technique for procedural sedation or general anesthesia for brief surgical procedures).

Operative hysteroscopy is a brief surgical procedure usually performed under general anesthesia with intravenous agents (propofol plus fentanyl) and positive pressure ventilation through facial or laryngeal mask.

The aim of this study is to investigate the effects of THRIVE apnoeic ventilation during hysteroscopy under general anesthesia. Our primary outcome is to describe the trend of SpO2 and tcCO2 during the procedures.

Secondary outcomes include description of arrhythmias requiring medical treatment, hemodynamic instability, unmanageable copious secretions, airway obstruction or inability to maintain airway patency, witnessed aspiration, airway related complications, number of airway manipulations, adverse events, assessment of postoperative dyspnoea and comfort, patient satisfaction.

Women (> 18 years old and < 70 years old), ASA physical status I and II presenting for elective operative hysteroscopies will be included.

A number of 30 patients was planned to target the primary outcome.

Descripción general del estudio

Estado

Terminado

Descripción detallada

Background Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE), term coined by Patel and Nouraei, refers to a technique that allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min using the Optiflow THRIVE-TM system (Fisher and Paykel Healthcare Ltd, Auckland, New Zealand), in order to maintain viable gas exchange during an extended period of cessation of muscular activity.

Apnoeic oxygenation is a physiological phenomenon in which oxygen flow into the lungs is driven by a negative pressure gradient generated by the difference between the alveolar rates of oxygen absorption and carbon dioxide excretion.

Potentially rapid and dangerous rise in carbon dioxide concentration is prevented by the underlying mechanisms occurring during high-flow nasal oxygenation under apnoeic conditions.

As proposed by Slutsky and more recently by Hermez, cardiogenic oscillations (changes in airway gas flow and pressure synchronous with the cardiac cycle) and their interactions with supraglottic turbulence generated by high-flow nasal oxygenation might be the underlying mechanisms of THRIVE and of the enhanced clearance of carbon dioxide.

Many clinically relevant benefits have been associated with nasal high flow. It provides a constant FiO2 by delivering the gas at flow rates that exceed the patient's peak inspiratory flow rate. It is effective in providing a flow-dependent effect of continuous positive airway pressure of about 1 cmH20 for every 10 L/min increase in gas flow within a range of 30-50 L/min, up to 11.9 cm H20 at a maximum flow of 100 L/min. Moreover, it reduces respiratory rate, it clears in a dose-dependent manner dead space of the upper airways and possibly even below the soft palate, leading to a reduction in rebreathing of expired air, with the potential to increase the alveolar volume and to improve alveolar ventilation and gas exchange. It is likely that, especially in patients with mild to moderate respiratory failure, enhanced comfort from heated humidification and flushing of dead space, lessen the work of breathing, thus improving thoraco-abdominal synchrony. By contrast, in spontaneously breathing patients, as a consequence of the large amount of air inflated into the stomach, higher number of reflux events could be detected increasing the risks of aspiration.

This technique has been successfully applied in several clinical settings to extend the apnoeic window after the induction of general anesthesia and during laryngoscopy in predicted difficult airway management. As long as airway patency was present, it succeeded in extending the apnoeic window up to 65 minutes. PaO2 and peripheral oxygen saturation remained stable and the rate of rise of CO2 during apnoea was reduced from earlier findings of 0.5 kPa/min with conventional low-flow systems to 0.15 kPa/min.

THRIVE has also been used as unique airway management technique for procedural sedation or when general anesthesia was performed for brief surgical procedures: it was able to keep patients with mild systemic disease well oxygenated, maintaining PaO2 stable with decreased rates of rise of CO2 during apnoea, as compared to conventional low-flow systems for oxygen therapy, such as the Venturi mask.

Operative hysteroscopy is a brief surgical procedure (< 30 minutes), usually performed in a day-surgery regimen. Typical anesthesiologic management in this setting includes general anesthesia with intravenous agents (propofol plus fentanyl) and positive pressure ventilation through laryngeal mask (I-gel). The application of THRIVE in this setting has potential advantages either for the patient, including minimal airway manipulation and greater comfort, either for the anesthesia provider, facilitating procedural technique and airway management.

Aim of the study The aim of this study is to investigate the effects of THRIVE apnoeic ventilation during operative hysteroscopy under general anesthesia.

Monitoring Standard perioperative monitoring will include non-invasive blood pressure (NIBP) with an upper arm cuff, 3-lead ECG, peripheral oxygen saturation (SpO2) and bispectral index (BIS). NIBP will be measured every 5 minutes before induction of anesthesia and throughout the procedure. Transcutaneous carbon dioxide (tcCO2) will be continuously monitored by Radiometer TCM5 monitor.

Study protocol Upon arrival on the operating theatre, each patient will be placed in supine position in lithotomic position; a peripheral venous cannula will be inserted on the hand or forearm and 500 ml Ringer-Lactate solution infusion will be started. Omeprazole 40 mg and dexametasone 4 mg will be given preoperatively. 3 minutes of pre-oxygenation will be performed with 100% oxygen 30 L/min delivered via dedicated Optiflow THRIVE-TM nasal cannulae. General anesthesia will then be induced with target-controlled infusion (TCI) of propofol (7 mcg/kg) through Orchestra Infusion system (Fresenius Kabi) plus fentanyl (1,5 mcg/kg). The range of maintenance of propofol concentration will be 4-6 mcg/ml, titrated to maintain a level of anesthesia monitored by BIS between 40 and 50. With the onset of general anesthesia oxygen flow will be increased to 70 L/min and maintained throughout the procedure. Head repositioning, jaw thrust, oropharyngeal cannula placement could be used to improve airway patency during the procedure. In case of episodes of oxygen desaturation, defined as SpO2<94%, or rise of tcCO2 over 45 mmHg, positive pressure ventilation by facial mask or laryngeal mask will be applied by the practitioner based on clinical judgement.

At the end of the procedure, propofol will be stopped. Paracetamol 1g, ondansetron 4 mg and ketorolac 30 mg will be administered as routine clinical practice.

The awake patient will be moved to the PACU for three hours of post-operative monitoring as required by internal practice for day-surgery procedures. Standard monitoring will include NIBP measured every 15 minutes, 3-lead ECG, and peripheral oxygen saturation (SpO2).

One hour after the end of the procedure and before discharge from the PACU the patient will be asked to rate its perceived degree of dyspnoea with the Borg dyspnoea score and its degree of comfort by Visual Numerical Scale (VAS).

In case of episodes of oxygen desaturation, defined as SpO2<94%, supplemental oxygen will be initially provided to the patient by low-flow Venturi mask with FiO2 40%.

Discharge from the PACU will require an Aldrete score of 9-10.

Sample size calculation For this pilot study no sample size calculation was performed.

Tipo de estudio

De observación

Inscripción (Actual)

30

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

      • Rome, Italia, 00168
        • IRCCS Policlinico Agostino Gemelli

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 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

Women scheduled for elective operative hysteroscopies will be included.

Descripción

Inclusion Criteria:

  • ASA I-II.

Exclusion Criteria:

  • BMI > 30,
  • pregnancy,
  • cardiac arrhythmia,
  • high risk of aspiration,
  • neuromuscular disease,
  • patient refusal.

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

  • Modelos observacionales: Solo caso
  • Perspectivas temporales: Futuro

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
change of tCO2 during THRIVE ventilation.
Periodo de tiempo: pre-anesthesia; up to 1 hour.
CO2 values (reported as mmHg) measured by Radiometer monitor.
pre-anesthesia; up to 1 hour.
change of SpO2 during THRIVE ventilation.
Periodo de tiempo: pre-anesthesia; up to 1 hour.
SpO2 values (reported as "%") measured by oxymeter.
pre-anesthesia; up to 1 hour.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Airway related complications.
Periodo de tiempo: 2 hours after the end of anesthesia.
Incidence of patients requiring airway manipulations (nasal cannula, manual ventilation, laryngeal mask ventilation, tracheal intubation) by the anesthesiologist, reported as "% of total number of patients".
2 hours after the end of anesthesia.
Postoperative complications - 1
Periodo de tiempo: 2 hours after the end of anesthesia.
Incidence of patients suffering from cough, sore throat, dysphagia, dysphonia, laryngospasm, oxygen desaturation (defined as SpO2<94%), reported as "% of total number of patients"
2 hours after the end of anesthesia.
Postoperative complications - 2
Periodo de tiempo: 2 hours after the end of anesthesia.
Incidence of dyspnoea (measured with Borg dyspnoea score: 0= no dyspnoea, 10= maximal dyspnoea).
2 hours after the end of anesthesia.
Postoperative complications - 3
Periodo de tiempo: 2 hours after the end of anesthesia.
Incidence of discomfort (measured with Visual Analogue Scale: 0= no discomfort, 10= maximal discomfort).
2 hours after the end of anesthesia.

Colaboradores e Investigadores

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

Publicaciones y enlaces útiles

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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 (Actual)

1 de febrero de 2022

Finalización primaria (Actual)

1 de abril de 2022

Finalización del estudio (Actual)

1 de mayo de 2022

Fechas de registro del estudio

Enviado por primera vez

19 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

21 de marzo de 2022

Publicado por primera vez (Actual)

22 de marzo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de mayo de 2022

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

24 de mayo de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 4631

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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