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

Not Applicable

Completed

• Conditions: Respiratory Complication
• Interventions: Procedure: Clamping of the ventilator endotracheal tube

• Registration Number: NCT04159220
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Study Start: 2020-01-17
• Primary Completion: 2023-12-18
• Study Completion: 2023-12-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clamping group	Clamping of the ventilator endotracheal tube	The transport will be released with a clamping of endotracheal tube before each disconnection from ventilator.

Primary Outcome Measures

Name	Time	Method
Measure of the pa02/Fi02	1 hour after the end of the transport	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.

Secondary Outcome Measures

Name	Time	Method
length of stay	up to 28 days	Evaluate the impact of the intervention on the length of ICU stay
occurrence of adverse events during the HIT	immediately after the end of the HIT	occurrence of adverse events related to the clamping
duration of invasive ventilation	up to 28 days	Evaluate the impact of the intervention on the invasive ventilation
Assessment of the pa02	6 hours after the end of of the HIT	Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator

Trial Locations

Locations (1)

Departement d'anesthésie et réanimation Gui de Chauliac (DAR C); 🇫🇷 Montpellier, France