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

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)

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 645

Contacts and Locations

• Study Contact: Name: Raphaël CLERE-JEHL; Phone Number: +33 1 45 86 51 99; Email: raphael.clere@gmail.com

Study Locations

• France
  • Strasbourg, France
    • Recruiting
    • CHU de Strasbourg
    • Contact: Raphaël CLERE-JEHL; Phone Number: +33 1 45 86 51 99; Email: raphael.clere@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients hospitalized in an ICU and requiring an intra-hospital transport with a departure from ICU and arrival to ICU will be eligible.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of non-serious adverse events occurring during intra-hospital transport.	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)	During the intra-intrahospital transport [maximum 3 hours]
Incidence of serious adverse events occurring during intra-hospital transport.	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)	During the intra-intrahospital transport [maximum 3 hours]

Collaborators and Investigators

• Sponsor: French Society for Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care unit; Intra-hospital transport; Critical ill patients
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2023-A00866-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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