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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01100957

Enrollment

Registered

2010-04-09

Start date

2009-10-31

Completion date

2010-12-31

Last updated

2011-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Airway, Tracheal Intubation

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.

Interventions

PROCEDUREtracheal intubation with a single use flexible videoscope

tracheal intubation with a single use flexible videoscope

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
time for preparing and cleaning the endoscopes	september 2010	this is measured in the hour before and after 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
Quality of the image from the videoscope	september 2010	Observed immediately before, and during, the intubation

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026