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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:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01323049
First received: March 24, 2011
Last updated: October 9, 2014
Last verified: October 2014

March 24, 2011
October 9, 2014
March 2012
February 2014   (final data collection date for primary outcome measure)
Spontaneous ventilation (air) time without desaturation after extubation (min) [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
desaturation is defined as an SpO2< 92%
Same as current
Complete list of historical versions of study NCT01323049 on ClinicalTrials.gov Archive Site
  • presence/absence of a desaturation after extubation [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
    desaturation is defined as an SpO2<92%
  • minimum Sp02 level after extubation (%) [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
  • minimum Sp02 level after extubation (%) [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • presence/absence of complications [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
    coughing, airway obstruction, laryngospasm, desaturation, apnea, vomiting in the first hour
  • presence / absence of therapeutic maneuvers [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia
Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Anesthesia, General
  • Procedure: Positive pressure extubation
    Positive pressure extubation will be used for patients waking up from general anesthesia
  • Procedure: Aspiration/suction extubation
    Aspiration/suction extubation will be used for patients waking up from general anesthesia
  • Active Comparator: Positive pressure extubation
    Positive pressure extubation will be used for patients waking up from general anesthesia in this group
    Intervention: Procedure: Positive pressure extubation
  • Active Comparator: Aspiration/suction extubation
    Aspiration/suction extubation will be used for patients waking up from general anesthesia in this group
    Intervention: Procedure: Aspiration/suction extubation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
February 2014
February 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01323049
LOCAL/2010/JL-03
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Joël L'Hermite, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP