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RecruitingNCT07646249VENTICRITUpdated Sep 11, 2026

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

An observational study in Respiration, Artificial, Positive-Pressure Respiration and Postoperative Complications (Cardiopulmonary), sponsored by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Eligibility criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Ventilation strategies applied during transport

    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.

    Time frame: Periprocedural period

Secondary outcomes

  1. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in vital signs (SpO2 in %) in the peritransport period .

    Time frame: 30 minutes before- 30 minutes after

  2. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in vital signs (EtCO2 mmHg) in the peritransport period .

    Time frame: 30 minutes before- 30 minutes after

  3. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in vital signs (Blood pressure in mmHg), in the peri-transport period

    Time frame: 30 minutes before- 30 minutes after

  4. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in vital signs (heart rate in beats per minute) , in the peri-transport period.

    Time frame: 30 minutes before- 30 minutes after

  5. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in vital signs ( ECG ST interval modifications) in the peri-transport period.

    Time frame: 30 minutes before - 30 minutes after

  6. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in blood gas analysis (pH) in the peri-transport period .

    Time frame: 30 minutes before - 30 minutes after

  7. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in blood gas analysis (PaO2 in mmHg) in the peri-transport period .

    Time frame: 30 minutes before - 30 minutes after

  8. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in blood gas analysis (lactate concentration) in the peri-transport period .

    Time frame: 30 minutes before - 30 minutes after

  9. assess changes in respiratory mechanics parameters before and 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)

    Time frame: 30 minutes before transport - 30 minutes after transport

  10. assess changes in respiratory mechanics parameters before and 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)

    Time frame: 30 minutes before transport - 30 minutes after transport

  11. assess modification of mechanical ventilation setup

    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).

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  12. incidence of adverse events

    report the incidence of adverse events such as number of desaturation (descriptive outcome) during transport.

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  13. sedation plan and any curarization applied

    Describe the sedation plan and any curarization applied during transport.

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  14. Inotropic/vasopressor medications applied and/or modified

    Report the number of any inotropic/vasopressor medications application (descriptive outcome) 30 minutes before, during, and 30 minutes after transport.

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  15. Incidence of PPCs

    Report the incidence of PPCs within 5 postoperative days.

    Time frame: within 5 postoperative days

  16. assess modification of mechanical ventilation setup

    possible application of corrective measures (application and/or modification of positive end-expiratory pressure - descriptive outcome)

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  17. assess modification of mechanical ventilation setup

    possible application of corrective measures (application of recruitment maneuvers- descriptive outcome).

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  18. incidence of adverse events

    report the incidence of adverse events such as number of episodes of hemodynamic instability (descritptive outcome) during transport.

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  19. incidence of adverse events

    report the incidence of adverse events such as episodes of cardiocirculatory arrest (descriptive outcome) during transport.

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  20. incidence of adverse events

    report the incidence of adverse events such as arrhythmia events (descriptive outcome), during transport.

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  21. incidence of adverse events

    report the incidence of adverse events such as accidental extubation (descriptive outcome) during transport.

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  22. Inotropic/vasopressor medications applied and/or modified

    Report the number of modifications in inotropic/vasopressor medications (descriptive outcome) 30 minutes before, during, and 30 minutes after transport.

    Time frame: 30 minutes before transport - 30 minutes after transport (whole transport period)

  23. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in blood gas analysis (bicarbonate concentration) in the peri-transport period .

    Time frame: 30 minutes before - 30 minutes after

  24. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in blood gas analysis (PaCO2 in mmHg) in the peri-transport period .

    Time frame: 30 minutes before - 30 minutes after

  25. assess changes in vital signs and blood gas analysis in the peri-transport period

    assess changes in blood gas analysis (PaO2/FiO2 in mmHg) in the peri-transport period .

    Time frame: 30 minutes before - 30 minutes after

06

Study locations

1 of 1 sites recruiting
  • Azienda Ospedaliero-Universitaria di Alessandria
    Alessandria, Italy 15121, Italy
    Recruiting
07

References and documents

Publications

  • 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
08

Registry details

Key details

Study ID
NCT07646249
Lead sponsor
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Collaborators
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
Sep 7, 2026
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

RICERCA SIAARTI Ufficio Ricerca Clinica, Clinical Trial Office
Contact
ricerca@siaarti.it
0039 06 4452816

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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