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Clinical Trials/NCT01323049
NCT01323049
Completed
Not 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 Nīmes1 site in 1 country68 target enrollmentMarch 1, 2012
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ConditionsAnesthesia, General

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, General
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
68
Locations
1
Primary Endpoint
Spontaneous ventilation (air) time without desaturation after extubation (min)
Status
Completed
Last Updated
5 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2012
End Date
February 25, 2014
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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