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

Tracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100957
• Other study ID #: aScope-1+2 a
• Secondary ID: H-A-2009-022
• Status: Completed
• Phase: N/A
• First received: March 25, 2010
• Last updated: August 23, 2011
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark:De Videnskabsetiske komiteer i Region Hovedstaden
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Difficult Airway
• Tracheal Intubation

Intervention

Procedure:
• tracheal intubation with a single use flexible videoscope
tracheal intubation with a single use flexible videoscope

Locations

Country	Name	City	State
Denmark	Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	time for preparing and cleaning the endoscopes	this is measured in the hour before and after the intubation	september 2010	No
Secondary	number of intubation attempts	measured during the intubation	september 2010	No
Secondary	success rate of endotracheal intubation	measured during the intubation	september 2010	No
Secondary	total time for the intubation-procedure inclusive the time for distributing local analgesics	measured during the intubation	september 2010	No
Secondary	Quality of the image from the videoscope	Observed immediately before, and during, the intubation	september 2010	No
Secondary	Evaluation of the insertion cord of the flexible scope	measured during the intubation	september 2010	No
Secondary	Evaluation of the working-/-injection-channel	measured during the intubation	september 2010	No