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

Pyloric Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02775214
• Other study ID #: 1306011553
• Status: Terminated
• Phase: N/A
• Start date: September 2013
• Est. completion date: July 12, 2022

Study information

• Verified date: October 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: July 12, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Intubation, Pediatric
• Pyloric Stenosis

Intervention

Device:
• Video Laryngoscopy

Locations

Country	Name	City	State
United States	Riley Hospital for Children at IU Health	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Had Desaturation Below 80% During Intubation	Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope	During intubation attempt (less than two minutes)