Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope
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
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 22, 2015
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedSeptember 26, 2017
January 1, 2016
3.1 years
November 22, 2015
September 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intubation Time
36 months
Secondary Outcomes (1)
Occurrence of throat pain measured by VAS
36 months
Study Arms (2)
Fiberoptic bronchoscope
EXPERIMENTALIn 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
EXPERIMENTALIn 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.
You may not qualify if:
- ASA class IV or V,
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Ximing Qi, PHD
The First Hospital of Qinhuangdao
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2015
First Posted
February 1, 2016
Study Start
July 1, 2012
Primary Completion
August 1, 2015
Study Completion
October 1, 2015
Last Updated
September 26, 2017
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will share