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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Complication

Intervention / Treatment
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* Procedure: Clamping of the ventilator endotracheal tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |