Does Positive Pressure Extubation Reduce Postoperative Desaturation?

Study Overview
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Brief Summary
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Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations

Detailed Description
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Study realise on university hospital on Lille in France. Patients inclusion is prospective and randomised in three groups. First group : extubation is realised with aspiration in tracheal tube during removal tube Second group : extubation is realised without aspiration but with APL valve set to 20cmH20 Third group : extubation is realised without aspiration but with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room

Official Title
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The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery

Conditions
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Extubation, Postoperative Complications, Lung Ultrasound Score

Intervention / Treatment
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* Procedure: positive pressure during extubation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Visceral or urological surgery Scheduled surgery Surgical or patient requirement: placement of an arterial catheter Supine position Post-surgical extubation scheduled in the operating room Minimum age of 18 years Informed and signed consent Exclusion Criteria: Severe obesity (BMI over 35kg/m2) pregnant woman Acute or chronic preoperative respiratory pathology. Sleep apnea syndrome Inability to receive informed information (does not speak, read or understand French) Patient under guardianship or curatorship Lack of social security coverage History of intubation or criteria for difficult intubation or ventilation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Classical extubation technique : ETT was removed with continuous endotracheal suction | |
| Experimental: VSPEP<br>ETT was removed with APL valve set to 20cmH2O | Procedure: positive pressure during extubation procedure<br>* positive pressure during extubation procedure<br>|
| Experimental: VSAIPEP<br>ETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room | Procedure: positive pressure during extubation procedure<br>* positive pressure during extubation procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| desaturations during extubation | saturation <92% | 1 minute after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| desaturation postoperatory | saturation<92% | 5 and 30 minutes after extubation | 
| hypoxemia post operatory | PaO2 <60mmHg | 1 and 30 minutes after extubation | 
| atelectasis | Lung ultrasound score (LUS); min = 0, max = 32, higher scores mean is worse outcome | 30 minutes after extubation | 
| awakening time | time in seconds | through extubation completion, an average 2 minutes | 
| use of oxygen | days Numbers of oxygen therapy, kinesiotherapy, non invasive ventilation | day 7 | 
| post operative complications | Clavien Dindo Score; min = grade I, max = grade V; higher scores mean is worse outcome | day 7 and day 28 | 
| feasibility and acceptance of both techniques pressure positive extubation | questionnaire, min = 4, max =20, higher scores mean is worse outcome | 15 minutes after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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positive pressure extubation, Postoperative Complications, lung ultrasound score