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

Rigshospitalet

Status: Completed

Conditions: Tracheal Intubation; Difficult Airway

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01100957

aScope-1+2 a

H-A-2009-022

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Conventional flexible videoscope for intubation

Active Comparator group

Treatment:

Procedure: tracheal intubation with a single use flexible videoscope

Single-patient flexible endoscope

Experimental group

Description:

Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm

Treatment:

Procedure: tracheal intubation with a single use flexible videoscope