NCT07646249

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

March 4, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Intra-hospital TransportMechanical VentilationManual VentilationRespiration, ArtificialPositive-Pressure RespirationPostoperative CarePostoperative ComplicationsPostoperative Pulmonary ComplicationsCritical IllnessIntensive Care UnitsEndotracheal IntubationGeneral AnesthesiaNon-Cardiac Surgery

Outcome Measures

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.

    Periprocedural period

Secondary Outcomes (25)

  • assess changes in vital signs and blood gas analysis 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

    30 minutes before- 30 minutes after

  • assess changes in vital signs and blood gas analysis 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

    30 minutes before- 30 minutes after

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

    30 minutes before - 30 minutes after

  • +20 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Intubated patients undergoing general anesthesia for non-cardiac surgery
  • Requirement for postoperative IMV
  • Age ≥18 years

You may not qualify if:

  • Patients undergoing cardiac surgery
  • Patients receiving preoperative mechanical ventilation prior to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Respiratory AspirationPostoperative ComplicationsCritical Illness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Central Study Contacts

RICERCA SIAARTI Ufficio Ricerca Clinica, Clinical Trial Office

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

June 12, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06