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VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU (VENTICRIT)

VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU - A Multicenter Observational Study

Patients undergoing major non-cardiac surgery may require postoperative mechanical ventilation and transfer from the operating room to the intensive care unit (ICU). This intra-hospital transport phase is critical, as patients may experience changes in respiratory and hemodynamic status, including alterations in oxygenation, ventilation, blood pressure, and heart rate.

During transport, ventilatory support may be provided using different strategies, including manual ventilation with a bag-valve device or mechanical ventilation with a portable ventilator. Although both approaches are commonly used in clinical practice, there is limited evidence comparing their effects on respiratory function, gas exchange, and overall physiological stability during and after transport.

This multicenter, prospective observational study aims to describe current clinical practices in ventilatory support during intra-hospital transport in adult patients undergoing non-cardiac surgery who require ICU admission. The study will also evaluate changes in vital signs, arterial blood gas parameters, and respiratory mechanics, as well as the occurrence of adverse events during transport and postoperative pulmonary complications within the first five days after surgery.

No additional interventions or procedures beyond standard clinical care will be performed. All data will be collected as part of routine clinical practice. The results of this study are expected to improve the understanding of ventilation management during transport and to identify safer and more effective strategies for critically ill postoperative patients.

Descripción general del estudio

Descripción detallada

Intra-hospital transport from the operating room to the intensive care unit (ICU) represents a vulnerable phase for critically ill postoperative patients, particularly for those who remain intubated and require ongoing invasive mechanical ventilation. During this period, patients may develop respiratory and hemodynamic instability, including hypoxemia, ventilation impairment, and adverse cardiovascular events.

In current clinical practice, ventilatory support during transport may be provided either manually, using a bag-valve device, or mechanically, using portable ventilators. Manual ventilation is widely used but may result in variability in tidal volume, airway pressures, respiratory rate, and minute ventilation. In contrast, mechanical ventilation may allow more controlled and protective respiratory support during transport. However, there is limited evidence describing the real-world use of these strategies and their associated physiological effects in patients undergoing non-cardiac surgery.

The VENTICIRT study is a multicenter, prospective observational study designed to describe ventilation practices during intra-hospital transport from the operating room to the ICU in adult patients undergoing non-cardiac surgery under general anesthesia who require postoperative ICU admission for continuation or weaning of invasive mechanical ventilation.

Data will be collected as part of routine clinical care without any modification of standard practice. The study will record patient demographics, surgical and anesthetic characteristics, ventilatory support modality during transport (manual versus mechanical), transport duration, and ventilator settings when applicable. Physiological variables, including vital signs, arterial blood gas values, and respiratory mechanics, will be assessed before and after transport according to routine clinical timing.

Adverse events occurring during transport and postoperative pulmonary complications within five days after surgery will also be documented.

By providing a comprehensive description of current ventilation strategies, their physiological impact, and associated clinical outcomes, this study aims to improve understanding of intra-hospital transport management and to generate evidence that may support safer and more effective care of critically ill postoperative patients.

Tipo de estudio

De observación

Inscripción (Estimado)

800

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.

Estudio Contacto

  • Nombre: RICERCA SIAARTI Ufficio Ricerca Clinica, Clinical Trial Office
  • Número de teléfono: 0039 06 4452816
  • Correo electrónico: ricerca@siaarti.it

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Intubated adult patients (≥18 years) undergoing general anesthesia (intravenous or mixed) for non-cardiac surgery, requiring transport from the operating room to the ICU for continuation/weaning from IMV in the postoperative period.

Descripción

Inclusion criteria

  • Intubated patients undergoing general anesthesia for non-cardiac surgery
  • Requirement for postoperative IMV
  • Age ≥18 years
  • Obtained informed consent Exclusion criteria
  • Patients undergoing cardiac surgery
  • Patients receiving preoperative mechanical ventilation prior to surgery.

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ventilation strategies applied during transport
Periodo de tiempo: Periprocedural period
Describe the ventilation strategies applied during transport from the operating room to ICU of the intubated patients subjected to general anesthesia for non-cardiac surgery requiring continuation of IMV in the postoperative period.
Periprocedural period

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before- 30 minutes after
assess changes in vital signs (SpO2 in %) in the peritransport period .
30 minutes before- 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before- 30 minutes after
assess changes in vital signs (EtCO2 mmHg) in the peritransport period .
30 minutes before- 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before- 30 minutes after
assess changes in vital signs (Blood pressure in mmHg), in the peri-transport period
30 minutes before- 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before- 30 minutes after
assess changes in vital signs (heart rate in beats per minute) , in the peri-transport period.
30 minutes before- 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before - 30 minutes after
assess changes in vital signs ( ECG ST interval modifications) in the peri-transport period.
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (pH) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (PaO2 in mmHg) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (lactate concentration) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in respiratory mechanics parameters before and after transport
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport
assess changes in respiratory mechanics parameters (respiratory system compliance in ml/cmH2O), before and after transport (30 minutes before transport - 30 minutes after transport)
30 minutes before transport - 30 minutes after transport
assess changes in respiratory mechanics parameters before and after transport
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport
assess changes in respiratory mechanics parameters (optional calculation of airway resistance cmH2O/(l/s)), before and after transport (30 minutes before transport - 30 minutes after transport)
30 minutes before transport - 30 minutes after transport
assess modification of mechanical ventilation setup
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
possible application of corrective measures (application or not of protective ventilation defined according to driving pressure in cmH2O and/or tidal volume in ml/kg of predeicted body weigth - descriptive outcome).
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as number of desaturation (descriptive outcome) during transport.
30 minutes before transport - 30 minutes after transport (whole transport period)
sedation plan and any curarization applied
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
Describe the sedation plan and any curarization applied during transport.
30 minutes before transport - 30 minutes after transport (whole transport period)
Inotropic/vasopressor medications applied and/or modified
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
Report the number of any inotropic/vasopressor medications application (descriptive outcome) 30 minutes before, during, and 30 minutes after transport.
30 minutes before transport - 30 minutes after transport (whole transport period)
Incidence of PPCs
Periodo de tiempo: within 5 postoperative days
Report the incidence of PPCs within 5 postoperative days.
within 5 postoperative days
assess modification of mechanical ventilation setup
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
possible application of corrective measures (application and/or modification of positive end-expiratory pressure - descriptive outcome)
30 minutes before transport - 30 minutes after transport (whole transport period)
assess modification of mechanical ventilation setup
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
possible application of corrective measures (application of recruitment maneuvers- descriptive outcome).
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as number of episodes of hemodynamic instability (descritptive outcome) during transport.
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as episodes of cardiocirculatory arrest (descriptive outcome) during transport.
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as arrhythmia events (descriptive outcome), during transport.
30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
report the incidence of adverse events such as accidental extubation (descriptive outcome) during transport.
30 minutes before transport - 30 minutes after transport (whole transport period)
Inotropic/vasopressor medications applied and/or modified
Periodo de tiempo: 30 minutes before transport - 30 minutes after transport (whole transport period)
Report the number of modifications in inotropic/vasopressor medications (descriptive outcome) 30 minutes before, during, and 30 minutes after transport.
30 minutes before transport - 30 minutes after transport (whole transport period)
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (bicarbonate concentration) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (PaCO2 in mmHg) in the peri-transport period .
30 minutes before - 30 minutes after
assess changes in vital signs and blood gas analysis in the peri-transport period
Periodo de tiempo: 30 minutes before - 30 minutes after
assess changes in blood gas analysis (PaO2/FiO2 in mmHg) in the peri-transport period .
30 minutes before - 30 minutes after

Colaboradores e Investigadores

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

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

  • Morita Y. et al. Comparison of Manual and Mechanical Ventilation During Intensive Care Unit Transport Following Cardiac Surgery: Impact on Oxygenation, Ventilation, and Hemodynamic Stability. J Cardiothorac Vasc Anesth. 2025 Mar;39(3):644-652.LAS VEGAS investigators, Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications: LAS VEGAS - an observational study in 29 countries. Eur J Anaesthesiol. 2017 Aug;34(8):492-507 Matthay et al. A New Global Definition of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2024 Jan 1;209(1):37-47

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 (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de octubre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

4 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

12 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de junio de 2026

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

9 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

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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