Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

NCT01163656 | Completed Results

• 1 other identifier: 10-007533
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.

Conditions

Intubation

Keywords

Neonate; Laryngoscopes

Outcome Measures

Primary Outcomes (1)

• Time to Tracheal Intubation

  The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.

  Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.

Study Arms (2)

Direct Laryngoscopy

ACTIVE COMPARATOR

Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope.

Device: Miller Laryngoscope

Glidescope Cobalt Video Laryngoscopy

ACTIVE COMPARATOR

Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope.

Device: Glidescope Cobalt Video Laryngoscopes

Interventions

Miller Laryngoscope DEVICE

Device is used to facilitate tracheal intubation.

Also known as: tracheal intubation, laryngoscopy, direct laryngoscopy

Direct Laryngoscopy

Glidescope Cobalt Video Laryngoscopes DEVICE

The laryngoscope design with the integration of video technology into the laryngoscope blade.

Also known as: Glidescope Cobalt Video Laryngoscopy, Video Laryngoscopy

Glidescope Cobalt Video Laryngoscopy

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Scheduled to undergo elective surgery at CHOP
• American Society of Anesthesiologists (ASA) Physical Status I or II
• Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant
• Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -

You may not qualify if:

• At known or anticipated high risk for aspiration pneumonia
• Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist
• Emergency surgical procedure
• Patients with preoperative airway pathology or stridor -

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Intubation, Intratracheal; Laryngoscopy

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Results Point of Contact

• Title: John Fiadjoe, MD
• Organization: The Children's Hospital of Philadelphia

fiadjoej@email.chop.edu

215-590-3916

Study Officials

• John Fiadjoe, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2012
• Last Updated: January 31, 2013
• Results First Posted: January 18, 2013

Record last verified: 2013-01

Locations

US (1)