Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy

Indiana University

Status: Terminated

Conditions: Intubation, Pediatric; Pyloric Stenosis

Treatments: Device: Video Laryngoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02775214

1306011553

Details and patient eligibility

About

The purpose of this study is to compare two different ways of placing breathing tubes for surgery. Both ways are used currently to place breathing tubes and are safe and effective. This study seeks to determine if one way is better than the other for infants with pyloric stenosis.

Full description

Specific aims of this study include determining if there is a difference in the desaturation rates of the two different intubation techniques- Direct Laryngoscopy and the C-MAC video laryngoscope. Also is there a difference in intubation success between the two techniques, does intubation success vary with different training levels, and does desaturation rate differ among training levels.

Enrollment: 62 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Need general anesthesia for pyloromyotomy procedure
• Have been informed of the nature of the study and informed consent has been obtained from the legally responsible guardian

Exclusion criteria

• Abnormal/difficult airway
• Allergy to succinylcholine and/or propofol

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Conventional Direct Laryngoscopy

No Intervention group

Description:

Endotracheal intubation will be performed by conventional direct laryngoscopy.

Video Laryngoscopy

Active Comparator group

Description:

Endotracheal intubation will be performed by video laryngoscopy with the C-MAC.

Treatment:

Device: Video Laryngoscopy