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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323049
First Posted: March 25, 2011
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose
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.

Condition Intervention
Anesthesia, General Procedure: Positive pressure extubation Procedure: Aspiration/suction extubation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Spontaneous ventilation (air) time without desaturation after extubation (min) [ Time Frame: 10 minutes ]
    desaturation is defined as an SpO2< 92%


Secondary Outcome Measures:
  • presence/absence of a desaturation after extubation [ Time Frame: 10 minutes ]
    desaturation is defined as an SpO2<92%

  • minimum Sp02 level after extubation (%) [ Time Frame: 10 minutes ]
  • minimum Sp02 level after extubation (%) [ Time Frame: 60 minutes ]
  • presence/absence of complications [ Time Frame: 60 minutes ]
    coughing, airway obstruction, laryngospasm, desaturation, apnea, vomiting in the first hour

  • presence / absence of therapeutic maneuvers [ Time Frame: 60 minutes ]
    includes oxygen therapy (or bezel ventimasque), Guedel airway, mask assistance, re-intubation during the first hour

  • presence/absence of any complication [ Time Frame: 60 minutes ]

Enrollment: 68
Study Start Date: March 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Positive pressure extubation
Positive pressure extubation will be used for patients waking up from general anesthesia in this group
Procedure: Positive pressure extubation
Positive pressure extubation will be used for patients waking up from general anesthesia
Active Comparator: Aspiration/suction extubation
Aspiration/suction extubation will be used for patients waking up from general anesthesia in this group
Procedure: Aspiration/suction extubation
Aspiration/suction extubation will be used for patients waking up from general anesthesia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323049


Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Joël L'Hermite, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01323049     History of Changes
Other Study ID Numbers: LOCAL/2010/JL-03
First Submitted: March 24, 2011
First Posted: March 25, 2011
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
extubation strategy

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs