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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Anesthesia, General

Treatments: Procedure: Positive pressure extubation; Procedure: Aspiration/suction extubation

Study type: Interventional

Funder types: Other

Identifiers

NCT01323049

LOCAL/2010/JL-03

2011-A00051-40 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Positive pressure extubation

Active Comparator group

Description:

Positive pressure extubation will be used for patients waking up from general anesthesia in this group

Treatment:

Procedure: Positive pressure extubation

Aspiration/suction extubation

Active Comparator group

Description:

Aspiration/suction extubation will be used for patients waking up from general anesthesia in this group

Treatment:

Procedure: Aspiration/suction extubation