Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

Anesthesia, General Clinical Trial

Official title:

Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323049
• Other study ID #: LOCAL/2010/JL-03
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: March 25, 2015
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Procedure:
• Positive pressure extubation
Positive pressure extubation will be used for patients waking up from general anesthesia
• Aspiration/suction extubation
Aspiration/suction extubation will be used for patients waking up from general anesthesia

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous ventilation (air) time without desaturation after extubation (min)	desaturation is defined as an SpO2< 92%	10 minutes	Yes
Secondary	presence/absence of a desaturation after extubation	desaturation is defined as an SpO2<92%	10 minutes	Yes
Secondary	minimum Sp02 level after extubation (%)		10 minutes	Yes
Secondary	minimum Sp02 level after extubation (%)		60 minutes	Yes
Secondary	presence/absence of complications	coughing, airway obstruction, laryngospasm, desaturation, apnea, vomiting in the first hour	60 minutes	Yes
Secondary	presence / absence of therapeutic maneuvers	includes oxygen therapy (or bezel ventimasque), Guedel airway, mask assistance, re-intubation during the first hour	60 minutes	Yes
Secondary	presence/absence of any complication		60 minutes	Yes