NCT01323049CompletedNot Applicable
Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia
Centre Hospitalier Universitaire de Nīmes2 sites in 1 country68 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Spontaneous ventilation (air) time without desaturation after extubation (min)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Spontaneous ventilation (air) time without desaturation after extubation (min)
Time Frame: 10 minutes
desaturation is defined as an SpO2\< 92%
Secondary Outcomes
- presence/absence of a desaturation after extubation(10 minutes)
- minimum Sp02 level after extubation (%)(60 minutes)
- presence/absence of complications(60 minutes)
- presence / absence of therapeutic maneuvers(60 minutes)
- presence/absence of any complication(60 minutes)
Investigators
Study Sites (2)
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