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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Critical Illness; Respiration, Artificial; Positive-Pressure Respiration; Intensive Care Units; Postoperative Complications (Cardiopulmonary)

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: RICERCA SIAARTI Ufficio Ricerca Clinica, Clinical Trial Office; Phone Number: 0039 06 4452816; Email: ricerca@siaarti.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	30 minutes before- 30 minutes after
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 .	30 minutes before- 30 minutes after
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	30 minutes before- 30 minutes after
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.	30 minutes before- 30 minutes after
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.	30 minutes before - 30 minutes after
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 .	30 minutes before - 30 minutes after
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 .	30 minutes before - 30 minutes after
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 .	30 minutes before - 30 minutes after
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)	30 minutes before transport - 30 minutes after transport
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)	30 minutes before transport - 30 minutes after transport
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).	30 minutes before transport - 30 minutes after transport (whole transport period)
incidence of adverse events	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	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	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	Report the incidence of PPCs within 5 postoperative days.	within 5 postoperative days
assess modification of mechanical ventilation setup	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	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	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	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	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	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	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	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	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	assess changes in blood gas analysis (PaO2/FiO2 in mmHg) in the peri-transport period .	30 minutes before - 30 minutes after

Collaborators and Investigators

• Sponsor: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
• Collaborators: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Critical Illness; Mechanical Ventilation; Intensive Care Units; Postoperative Complications; General Anesthesia; Postoperative Pulmonary Complications; Postoperative Care; Positive-Pressure Respiration; Respiration, Artificial; Endotracheal Intubation; Intra-hospital Transport; Manual Ventilation; Non-Cardiac Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Critical Illness; Respiratory Aspiration; Postoperative Complications
• Other Study ID Numbers: SIAARTI.2025.05 - VENTICRIT (Other Identifier: SIAARTI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No