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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 April 2015 |
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Main ID: |
NCT01323049 |
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Date of registration:
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24/03/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public 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
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Scientific 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 |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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68 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01323049 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Joël L'Hermite, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de Nîmes |
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Key inclusion & exclusion 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)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anesthesia, General
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Intervention(s)
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Procedure: Aspiration/suction extubation
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Procedure: Positive pressure extubation
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Primary Outcome(s)
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Spontaneous ventilation (air) time without desaturation after extubation (min)
[Time Frame: 10 minutes]
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Secondary Outcome(s)
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minimum Sp02 level after extubation (%)
[Time Frame: 60 minutes]
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minimum Sp02 level after extubation (%)
[Time Frame: 10 minutes]
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presence / absence of therapeutic maneuvers
[Time Frame: 60 minutes]
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presence/absence of a desaturation after extubation
[Time Frame: 10 minutes]
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presence/absence of any complication
[Time Frame: 60 minutes]
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presence/absence of complications
[Time Frame: 60 minutes]
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Secondary ID(s)
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LOCAL/2010/JL-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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