Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care (ESCORTE)
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|ClinicalTrials.gov Identifier: NCT04159220|
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : March 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Complication||Procedure: Clamping of the ventilator endotracheal tube||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Controlled Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care|
|Actual Study Start Date :||January 17, 2020|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
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.
- Measure of the pa02/Fi02 [ Time Frame: 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.
- Assessment of the pa02 [ Time Frame: 1 hour after the end of the HIT ]Evaluate the impact of the procedure on the absence of PaO2 reduction (before transport and 1 hour after return to bed)
- Assessment of the pa02 [ Time Frame: immediately after the end of the HIT ]Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator
- Assessment of the pa02 [ Time Frame: 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
- length of stay [ Time Frame: up to 28 days ]Evaluate the impact of the intervention on the length of ICU stay
- duration of invasive ventilation [ Time Frame: up to 28 days ]Evaluate the impact of the intervention on the invasive ventilation
- occurrence of adverse events during the HIT [ Time Frame: immediately after the end of the HIT ]occurrence of adverse events related to the clamping
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159220
|Contact: Christine BERNARD, firstname.lastname@example.org|
|Departement d'anesthésie et réanimation Gui de Chauliac (DAR C)||Recruiting|
|Montpellier, France, 34295|
|Contact: christine Bernard, nurse 0033467337476 email@example.com|