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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 ] [ Designated as safety issue: Yes ]
    desaturation is defined as an SpO2< 92%


Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01323049     History of Changes
Other Study ID Numbers: LOCAL/2010/JL-03
Study First Received: March 24, 2011
Last Updated: October 9, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
extubation strategy

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014