Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation

Not Applicable

Completed

• Conditions: Tracheal Intubation; Difficult Airway
• Interventions: Procedure: tracheal intubation with a single use flexible videoscope

• Registration Number: NCT01100957
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The study is in two parts

Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.

Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.

The hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Status Verified: 2010-03
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2011-08-23
• Last Update Posted: 2011-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Study part 1:

   • Patients scheduled for tracheal intubation and predicted to have a normal airway
   • ASA class I, II or III
   • >18 years

2. Study part 2:

   • Adult patients scheduled for tracheal intubation and predicted to have a difficult airway
   • ASA class I, II or III
   • >18 years

Exclusion Criteria

1. Study part 1:

   • Massive bleeding from the mouth
   • Previously abandoned flexible optical intubation

2. Study part 2:

   • Massive bleeding from the mouth
   • Previously abandoned flexible optical intubation
   • Patients with audible stridor
   • Patients with dyspnea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional flexible videoscope for intubation	tracheal intubation with a single use flexible videoscope	-
Single-patient flexible endoscope	tracheal intubation with a single use flexible videoscope	Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm

Primary Outcome Measures

Name	Time	Method
time for completion of intubation	September 2010	This, the time for intubation, is measured immediately during the intubation, on the day that the specific patient participates in the study

Secondary Outcome Measures

Name	Time	Method
time for preparing and cleaning the endoscopes	september 2010	this is measured in the hour before and after the intubation
number of intubation attempts	september 2010	measured during the intubation
success rate of endotracheal intubation	september 2010	measured during the intubation
total time for the intubation-procedure inclusive the time for distributing local analgesics	september 2010	measured during the intubation
Quality of the image from the videoscope	september 2010	Observed immediately before, and during, the intubation
Evaluation of the insertion cord of the flexible scope	september 2010	measured during the intubation
Evaluation of the working-/-injection-channel	september 2010	measured during the intubation

Trial Locations

Locations (1)

Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071; 🇩🇰 Copenhagen, Denmark