Videolaryngoscope Versus Fiberoptic Bronchoscope for the Awake Intubation

NCT02169232 — Not applicable, Unknown, 40 participants, McGill University Health Centre/Research Institute of the McGill University Health Centre

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT02169232
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, health services research
Enrollment	40 (Estimated)
Sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Conditions	Need of Awake Intubation for Difficult Airways
Interventions	Videolaryngoscope, Fiberoptic (Device)
Dates	start 2014-05-01, primary completion 2015-05-01 (estimated), completion 2015-12-01 (estimated), first posted 2014-06-23, last updated 2014-06-23
Locations	1 site in Canada

-Summary

Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an airway while a patient is awake, has many limitations. The video laryngoscope is a device that is similar to a conventional laryngoscope but uses a video system to visualize the larynx. Because of its low cost, ease of use, and usefulness in the presence of edema or bleeding that may obstruct the airway, video assisted laryngoscopy has been shown to be useful for awake endotracheal intubations. However, a direct comparison of the fiberoptic bronchoscope with video assisted laryngoscopy has not been performed for awake endotracheal intubations in of obese patients. Patients undergoing laparoscopic gastric bypas andrecquiring awake intubations will be randomized for either fiberoptic bronchoscope or video assisted laryngoscopy. The investigators primary outcome will be the time required for successful intubation.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Videolaryngoscope	Active comparator	Device: Videolaryngoscope	Intubation by videolaryngoscope
Fiberoptic	Active comparator	Device: Fiberoptic	Intubation by fibroscope

Videolaryngoscope (Device), also known as Intubation by Glidoscope
Fiberoptic (Device)

+Outcome measures

Primary outcomes

The time required for successful intubation [10 minutes]: The time required for successful intubation, which will be measured as the time from which the bronchoscope or videolaryngoscope is initially introduced into the oropharynx, until the time that CO2 is registered on the capnogram.

Secondary outcomes

Number of intubation attempts, defined as a complete withdrawal and re-insertion of the airway instrument. [10 minutes]

Other outcomes

The ease of intubation using a 10 cm visual analogue scale, completed both by the person performing the intubation, and an independent observer. [one hour]
Post-operatively the patient's satisfaction [24 hours]: Post-operatively the patient's satisfaction with the procedure using a 10 cm visual analogue scale, a discomfort scale using a 10 cm visual analogue scale, whether they would recommend this procedure to a future patient, and the severity of sore throat using a 10 cm visual analogue scale.

+Eligibility

Sex: All, ages: 18 Years to 55 Years

Inclusion Criteria:

* morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital

Exclusion Criteria:

* moderate to severe systemic illness, i.e. American Society of Anesthesiologists (ASA) score of 4 or higher
* inability to communicate in English or French
* contraindications to the drugs used in the study

+Locations (1)

Facility	City	Country	Status
Royal Victoria Hospital	Montreal, Quebec	Canada	Recruiting

+Investigators

Albert Moore, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

My Notes

Public

To Read Reading Read