Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

Study Overview
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Brief Summary
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The primary objective is to show that positive pressure extubation improves oxygenation immediately after extubation compared to extubation via aspiration by evaluating and comparing the onset time of desaturation during spontaneous ventilation during awakening following general anesthesia.

Official Title
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Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

Conditions
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Anesthesia, General

Intervention / Treatment
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* Procedure: Positive pressure extubation
* Procedure: Aspiration/suction extubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 1 hour of follow up ASA 1 to 3 The patient is schedules for orthopedic surgery (limbs) with general anesthesia Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant The patient is breastfeeding Chronic respiratory insufficiency Cardiopathy Obstructive sleep apnea Two or more predictive criteria for difficult mask ventilation (age > 55 years, toothless, beard, snorer, BMI > 26) No predictive criteria for difficult intubation (SPIDS <= 10)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positive pressure extubation<br>Positive pressure extubation will be used for patients waking up from general anesthesia in this group | Procedure: Positive pressure extubation<br>* Positive pressure extubation will be used for patients waking up from general anesthesia<br>|
| Active Comparator: Aspiration/suction extubation<br>Aspiration/suction extubation will be used for patients waking up from general anesthesia in this group | Procedure: Aspiration/suction extubation<br>* Aspiration/suction extubation will be used for patients waking up from general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous ventilation (air) time without desaturation after extubation (min) | desaturation is defined as an SpO2< 92% | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence/absence of a desaturation after extubation | desaturation is defined as an SpO2<92% | 10 minutes | 
| minimum Sp02 level after extubation (%) |  | 10 minutes | 
| minimum Sp02 level after extubation (%) |  | 60 minutes | 
| presence/absence of complications | coughing, airway obstruction, laryngospasm, desaturation, apnea, vomiting in the first hour | 60 minutes | 
| presence / absence of therapeutic maneuvers | includes oxygen therapy (or bezel ventimasque), Guedel airway, mask assistance, re-intubation during the first hour | 60 minutes | 
| presence/absence of any complication |  | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extubation strategy