Comparison of Indirect and Direct Laryngoscopy in Obese Patients
Comparison of the C-MAC Video Laryngoscope With Conventional Direct Laryngoscopy in Morbidly Obese Patients Using a Photographic Overlay Technique
1 other identifier
interventional
N/A
1 country
1
Brief Summary
An anaesthetist inserts a "laryngoscope" into the mouth to see the voice-box (larynx) for "tracheal intubation", when a tube is advanced into the windpipe (trachea) to protect the airway and administer anaesthetic gases. This study aims to compare traditional (direct view) Macintosh (MAC) laryngoscopy with Storz C-MAC videolaryngoscopes in subjects presenting for obesity reduction surgery using a novel "photographic overlay technique" to analyse the basis for any differences.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2013
Longer than P75 for not_applicable
1 active site
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
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2019
CompletedJune 9, 2022
March 1, 2016
6 years
June 17, 2014
June 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
POGO (percentage of glottic opening) score at maximum laryngeal view for three laryngoscopes (Macintosh, Storz C-MAC, standard and D-BLADE)
one year
Secondary Outcomes (2)
Subjective "ease of intubation"
one year
Time to intubate
one year
Other Outcomes (2)
Anatomical features important in ensuring an adequate view of the larynx
one year
Differences in what ensures an adequate view of the larynx for direct and indirect viewing devices
one year
Study Arms (2)
Laryngoscopy sequence 1
ACTIVE COMPARATORMacintosh laryngoscopy Storz C-MAC, standard blade Storz C-MAC, D-BLADE
Laryngoscopy sequence 2
ACTIVE COMPARATORMacintosh Storz C-MAC, D-BLADE Storz C-MAC, standard blade
Interventions
Eligibility Criteria
You may qualify if:
- Obese patients (BMI \>35) for elective bariatric surgery
You may not qualify if:
- Patients in whom rapid sequence induction of anaesthesia is indicated
- Patients in whom the responsible anaesthetist considers conventional laryngoscopy inappropriate (e.g. when the mouth opening is too narrow)
- Patients whose comorbidity makes them unsuitable for this type of study (e.g. those with limited cardiopulmonary reserve)
- patients who do not consent to be involved in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aintree University Hospitals
Liverpool, Merseyside, L9 7AL, United Kingdom
Related Publications (1)
Charters P. Analysis of mathematical model for osseous factors in difficult intubation. Can J Anaesth. 1994 Jul;41(7):594-602. doi: 10.1007/BF03009999.
PMID: 8087908BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Charters
Aintree University Hospitals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 19, 2014
Study Start
January 1, 2013
Primary Completion
January 7, 2019
Study Completion
January 7, 2019
Last Updated
June 9, 2022
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share