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

Evaluation and Comparison of the New Single Use Ambu aScope With Olympus BF 160 Multiple Use Scope for Securing the Airway of the Anaesthetised/Awake Patients' Normal or Difficult Airway

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.

Study Overview

• Status: Completed
• Conditions: Difficult Airway; Tracheal Intubation
• Intervention / Treatment: Procedure: tracheal intubation with a single use flexible videoscope

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional flexible videoscope for intubation	Procedure: tracheal intubation with a single use flexible videoscope; tracheal intubation with a single use flexible videoscope
EXPERIMENTAL: Single-patient flexible endoscope; Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm	Procedure: tracheal intubation with a single use flexible videoscope; tracheal intubation with a single use flexible videoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time for completion of intubation	This, the time for intubation, is measured immediately during the intubation, on the day that the specific patient participates in the study	September 2010

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Michael S Kristensen, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: March 25, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (ESTIMATE): April 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 24, 2011
• Last Update Submitted That Met QC Criteria: August 23, 2011
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: aScope-1+2 a; H-A-2009-022