Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope

Not Applicable

Completed

• Conditions: Therapeutic Procedural Complication

• Registration Number: NCT02669550
• Lead Sponsor: The First Hospital of Qinhuangdao

Brief Summary

The fiberoptic bronchoscope (FOB) has been the preferred instrument for many years in the management of difficult tracheal intubation, and it is considered as a gold standard. The disposcope endoscope (DE) is a medical device for endotracheal intubation used in clinical practice recently.This study compares FOB and DE for awake orotracheal intubation in obese patients with anticipated difficult airway.

Detailed Description

Forty obese patients with anticipated difficult airways were randomised to undergo awake orotracheal intubation by FOB(group F) or DE(group D) after conscious sedation. The conditions of orotracheal intubation, the time needed to view the vocal cords and to complete the orotracheal intubation, the hemodynamic changes and the adverse events including bradycardia, respiratory depression during orotracheal intubation, throat pain, hoarseness and memory after surgery were recorded. The ease of view the vocal cords and passing the tracheal tube through the glottis were also evaluated by using a visual analogue scale (VAS) by operator.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Study First Submitted: 2015-11-22
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-01
• Last Update Submitted: 2017-09-23
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.

Exclusion Criteria

• Exclusion criteria included age younger than 18 yr,
• ASA class IV or V,
• Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Intubation Time	36 months

Secondary Outcome Measures

Name	Time	Method
Occurrence of throat pain measured by VAS	36 months