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

Critical Illness Clinical Trial

— TIGRHOU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455696
• Other study ID #: 2023-A00866-39
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: French Society for Intensive Care
• Contact: Raphaël CLERE-JEHL
• Phone: +33 1 45 86 51 99
• Email: raphael.clere[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 645
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Unit

Locations

Country	Name	City	State
France	CHU de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
French Society for Intensive Care

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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]