Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Medical University of Vienna

Status: Completed

Conditions: Infants; Difficult Airway

Treatments: Other: laryngoscopy with oxygen; Other: laryngoscopy without oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT01664234

ECS 1178/2012

Details and patient eligibility

About

Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.

Enrollment: 48 patients

Sex: All

Ages: 1 month to 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• infants (0-2) difficult airways

Exclusion criteria

• . Patients with American Society of Anesthesiologists physical status scores ≥3 congenital heart disease left-to-right shunting

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups, including a placebo group

laryngoscopy with simultaneous insufflation of oxygen

Experimental group

Description:

Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.

Treatment:

Other: laryngoscopy with oxygen

laryngoscopy without simultaneous oxygen insufflation

Placebo Comparator group

Description:

Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.

Treatment:

Other: laryngoscopy without oxygen