Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope

Study Overview
=================
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.

Official 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

Conditions
-----------------
Therapeutic Procedural Complication

Intervention / Treatment
-----------------
* Device: Fiberoptic bronchoscope
* Device: Disposcope endoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fiberoptic bronchoscope<br>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 | Device: Fiberoptic bronchoscope<br>* 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<br>|
| Experimental: Disposcope endoscope<br>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 | Device: Disposcope endoscope<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Time |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of throat pain measured by VAS |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fiberoptic bronchoscope, Disposcope endoscope, Awake orotracheal intubation