Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care (ESCORTE)

Randomized Controlled Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care

Intra hospital transport of ICU patients is still at high risk of respiratory complications.We propose to determine if endotracheal tube clamping prior to disconnect ventilator allows to avoid oxygenation decrease.

Study Overview

• Status: Completed
• Conditions: Respiratory Complication
• Intervention / Treatment: Procedure: Clamping of the ventilator endotracheal tube

Detailed Description

Changing respiratory support and multiples endotracheal tube disconnections may induce a loss of PEEP and finally lead to alveolar derecruitment. This study is an evaluation of a care procedure to limit the incidence of alveolar derecruitment in ventilated intubated ICU patients during transport for CT scan.

Intra hospital transport of ICU patients are performed by anesthesiologist nurses, the physician entrusts them this activity.

This is a randomized controlled study, the procedure is to clamp endotracheal tube before each disconnection from ventilator.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Departement d'anesthésie et réanimation Gui de Chauliac (DAR C)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• intensive care patient
• intubated, sedated, controlled assisted ventilation
• Intra hospital transport for CT scan
• arterial catheter
• the patient or his trusted person consent to the study

Exclusion Criteria:

• Patient Covid tests positive or Covid test results not received
• extubated, unsedated,
• reinforced tube
• tracheotomy
• pregnancy
• guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The transport will be released without a clamping of endotracheal tube before each disconnection from ventilator.
Experimental: Clamping group; The transport will be released with a clamping of endotracheal tube before each disconnection from ventilator.	Procedure: Clamping of the ventilator endotracheal tube; The transport will be released in accordance with SFAR SRLF guideline. Before each disconnection from ventilator endotracheal tube will be clamped.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of the pa02/Fi02	Evaluate the effectiveness of a procedure to avoid alveolar delisting, measured by the absence of a decrease in the PaO2/FiO2 ratio (before transport and 1 hour after return to bed) during an HIT performed by a nurse anaesthetist/caregiver team, of intubated and ventilated resuscitation patients in a controlled assisted volume.	1 hour after the end of the transport

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the pa02	Evaluate the impact of the procedure on the absence of PaO2 reduction (before transport and 1 hour after return to bed)	1 hour after the end of the HIT
Assessment of the pa02	Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator	immediately after the end of the HIT
Assessment of the pa02	Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator	6 hours after the end of of the HIT
length of stay	Evaluate the impact of the intervention on the length of ICU stay	up to 28 days
duration of invasive ventilation	Evaluate the impact of the intervention on the invasive ventilation	up to 28 days
occurrence of adverse events during the HIT	occurrence of adverse events related to the clamping	immediately after the end of the HIT

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2020
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RECHMPL19_0070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 12 months after the main publication
• IPD Sharing Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

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