Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

Respiratory Failure Clinical Trial

Official title:

Safety and Efficacy of Endotracheal Intubation by Pulmonary Critical Care Physicians in Critically-Ill Patients Using Glidescope Video-Laryngoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683526
• Other study ID #: 139-12
• Status: Completed
• Phase: N/A
• First received: September 6, 2012
• Last updated: October 9, 2014
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2014
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. This study will answer whether using a VL will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing urgent endotracheal intubation by a pulmonary critical care medicine physician

Exclusion Criteria:

• Difficult airway

• Oxygen saturation < 92% despite adequate mask ventilation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Direct laryngoscopy

Device:
• Video laryngoscopy (Glidescope)

Locations

Country	Name	City	State
United States	Beth Isreal Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Pass Success Rate		From begining of intubation to verification. Less then 5 minutes approximatly	Yes
Secondary	Severe Desaturation	sat <80%	For 10 minutes post intubation	Yes
Secondary	Hypotension	SBP<70	For 10 minutes post intubation	Yes
Secondary	Cardiac Arrest		For 1 hour post intubation	Yes
Secondary	Complications of Intubation	Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.	For 10 minutes post intubation	Yes