Intra-Hospital Transport of Critically Ill Patients in Intensive Care Unit

Recruiting

• Conditions: Critical Illness; Intensive Care Unit; Transportation Accidents

• Registration Number: NCT06455696
• Lead Sponsor: French Society for Intensive Care

Brief Summary

Intra-hospital transport is a frequent procedure in the ICU, involving patients with the highest severity scores. Although some studies estimate the rate of adverse events to be around 33% during intra-hospital transport, including 4% of serious adverse events, the epidemiological data available is small, heterogeneous, and probably subject to methodological bias.

The aim of this study observational prospective observatoinal study is to determine:

* the different practices existing between ICUs ("practice survey")

* the occurrence of adverse events during intra-hospital transport provided by intensive care units (epidemiological study)

Detailed Description

This is a multicenter prospective observational study on evaluation of practices between ICUs and to describe the occurence of adverse events during intra-hospital transport provided by ICUs (epidemiological study)

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-05-27
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 645

Inclusion Criteria

• Patients aged over 18 years old
• Hospitalized in ICU
• Requiring an intra-hospital transport (e.g imagery, operating room, etc) by the ICU team
• With a departure from ICU and arrival to ICU

Exclusion Criteria

• Person under guardianship
• Protected Majors
• Already included in the study
• Transport for an ICU discharge in a medical or surgical ward
• Transport with another team than the ICU team
• Not affiliated to French social security

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events during intra-hospital transport in critical ill patients managed by an ICU team	During the intra-intrahospital transport [maximum 3 hours]	The number of adverse events during intra-hospital transport managed by an ICU team, as a proportion of the number of transports performed.

Secondary Outcome Measures

Name	Time	Method
Incidence of non-serious adverse events occurring during intra-hospital transport.	During the intra-intrahospital transport [maximum 3 hours]	3) Rate of types of (non-serious) adverse events occurring during intra-hospital transport including O Rate of Withdrawal or mobilization of equipment with low risk of serious complication (e.g. VVP withdrawal, urinary catheter, nasogastric tube, mobilization of endotracheal tube without extubation) O Rate of Non-severe hemodynamic failures (occurrence of arterial hypotension with MAP between 40 and 65 mmHg, or catecholamine increase \< 10% during transport) O Rate of Non-severe respiratory failure (desaturation with a SpO2 ≥ 80%) O Rate of Metabolic failure (e.g. hypoglycemia on return from transport) O Rate of Neurological complications (consciousness disorders occurring without sedation, agitation) O Rate of Material failures (O2 or ventilator failure, electrical syringe pump failure)
Incidence of serious adverse events occurring during intra-hospital transport.	During the intra-intrahospital transport [maximum 3 hours]	4) Rate of serious adverse events occurring during intra-hospital transport including O Death O Cardiorespiratory arrest O Accidental extubation and/or need for re-intubation, or removal of high-risk equipment (e.g. central venous catheter, arterial catheter, endotracheal tube) O Severe hemodynamic failure (arterial hypotension with MAP \< 40 mmHg, introduction or increase of catecholamines ≥ 10% during transport) O Severe respiratory failure (desaturation with SpO2 \< 80% or massive inhalation)

Trial Locations

Locations (1)

CHU de Strasbourg; 🇫🇷 Strasbourg, France