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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07646249
Acronym
VENTICRIT
Enrollment
800
Registered
2026-06-12
Start date
2026-09-07
Completion date
2027-10-01
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Intensive Care Units, Positive-Pressure Respiration, Postoperative Complications, Postoperative Complications (Cardiopulmonary), Respiration, Artificial

Keywords

Intra-hospital Transport, Mechanical Ventilation, Manual Ventilation, Respiration, Artificial, Positive-Pressure Respiration, Postoperative Care, Postoperative Complications, Postoperative Pulmonary Complications, Critical Illness, Intensive Care Units, Endotracheal Intubation, General Anesthesia, Non-Cardiac Surgery

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Lead SponsorOTHER
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ventilation strategies applied during transportPeriprocedural periodDescribe 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.

Secondary

MeasureTime frameDescription
assess changes in vital signs and blood gas analysis in the peri-transport period30 minutes before- 30 minutes afterassess changes in vital signs (SpO2 in %) in the peritransport period .
assess changes in respiratory mechanics parameters before and after transport30 minutes before transport - 30 minutes after transportassess changes in respiratory mechanics parameters (respiratory system compliance in ml/cmH2O), before and after transport (30 minutes before transport - 30 minutes after transport)
assess modification of mechanical ventilation setup30 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).
incidence of adverse events30 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.
sedation plan and any curarization applied30 minutes before transport - 30 minutes after transport (whole transport period)Describe the sedation plan and any curarization applied during transport.
Inotropic/vasopressor medications applied and/or modified30 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.
Incidence of PPCswithin 5 postoperative daysReport the incidence of PPCs within 5 postoperative days.

Countries

Italy

Contacts

CONTACTRICERCA SIAARTI Ufficio Ricerca Clinica, Clinical Trial Office
ricerca@siaarti.it0039 06 4452816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026