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

Not Applicable

Completed

• Conditions: Anesthesia, General
• Interventions: Procedure: Positive pressure extubation; Procedure: Aspiration/suction extubation

• Registration Number: NCT01323049
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Study Start: 2012-03
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive pressure extubation	Positive pressure extubation	Positive pressure extubation will be used for patients waking up from general anesthesia in this group
Aspiration/suction extubation	Aspiration/suction extubation	Aspiration/suction extubation will be used for patients waking up from general anesthesia in this group

Primary Outcome Measures

Name	Time	Method
Spontaneous ventilation (air) time without desaturation after extubation (min)	10 minutes	desaturation is defined as an SpO2\< 92%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France