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Completed

NCT Number: NCT02669550

Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope

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.

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Key information

Conditions

Therapeutic Procedural Complication

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiberoptic bronchoscope

Device

In case of FOB, the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB

Disposcope endoscope

Device

In the DE group, the operator gripped the chin and lower incisors of patients with the fingers and thumb to open the mouth adequately wide and grasped the wire body, which was enclosed within the endotracheal tube, by the other hand and held it parallel to,then inserted into oral cavity

Primary outcomes

  1. Intubation Time

    Time frame: 36 months

Secondary outcomes

  1. Occurrence of throat pain measured by VAS

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

The First Hospital of Qinhuangdao

Other Gov

Registry information

Official study title

A Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope During Awake Orotracheal Intubation in Obese Patients With Anticipated Difficult Airway : A Prospective, Randomised and Controlled Clinical Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2016
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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