AzTrials
AzTrials

Respiration, ArtificialVENTICRITNCT07646249

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

An observational study of Respiration, Artificial and Positive-Pressure Respiration, run by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
800 participants
Where
1 siteItaly
Study dates
7 Sep 2026to 1 Oct 2027
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

RICERCA SIAARTI Ufficio Ricerca Clinica, Clinical Trial Office contact

0039 06 4452816

ricerca@siaarti.it

Italy1 site, 1 recruiting

  • Azienda Ospedaliero-Universitaria di Alessandria

    Alessandria, Italy, 15121

    Gianmaria Cammarota, +39 0131 206252, gianmaria.cammarota@ospedale.al.it

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read more

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.

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
Medical subject headings
Respiratory Aspiration, Postoperative Complications, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Periprocedural period

Secondary outcomes (25)

  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 .

    Measured: 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 .

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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 .

    Measured: 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 .

    Measured: 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 .

    Measured: 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)

    Measured: 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)

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 30 minutes before transport - 30 minutes after transport (whole transport period)

  15. Incidence of PPCs

    Report the incidence of PPCs within 5 postoperative days.

    Measured: 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)

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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 .

    Measured: 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 .

    Measured: 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 .

    Measured: 30 minutes before - 30 minutes after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start7 Sep 2026
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07646249
Sponsor's protocol ID
SIAARTI.2025.05 - VENTICRIT
Other IDs
SIAARTI.2025.05 - VENTICRIT
Acronym
VENTICRIT
Status last verified
Sep 2026
First submitted
4 Mar 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in