Clinical trial NCT03357679: Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation
Official title: Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation: A Randomised, Controlled, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bed up Head Elevated Intubation Position
Keywords: Bed up head elevated position
Glidescope assisted tracheal intubation
Laryngeal exposure
Time to intubation
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Positioning during the process of tracheal intubation is critical, as optimal positioning can greatly facilitate successful intubation. Many complications can occur as a result of failed intubation, ranging from airway injury, lack of oxygen, with even deaths. Today, the most popular positioning of patients for intubation is in the "sniffing" position. There is however evidence to support that intubation in the bed-up-head-elevated position may be better. In today's technological age, video assisted laryngoscopy (Laryngoscopy is the process of visualizing the vocal cords prior to intubation), a new method where the anaesthetist intubates a patient via aid of an image guided view of the airway, is increasingly popular due to its reliability and superiority to normal intubation. However, it is not widely available, and may suffer from technical breakdowns. The Glidescope is one example of a video laryngoscope, and has been widely researched in the medical literature. In this study, the investigators wish to investigate whether intubation in the bed-up-head-elevated position will be as good as, if not better than Glidescope assisted tracheal intubation, in patients undergoing elective surgery and planned for general anaesthesia.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing elective surgeries under general anaesthesia
2. Patients aged from 18 years old to 75 years old
3. Patients who are able to give informed consent

Exclusion Criteria:

1. Patients with airway obstruction
2. Patients with contraindications to neck extension
3. Patients with small mouth opening (\<3 cm)
4. BMI \> 35 kg/m3
5. Patients with ischemic heart disease, cerebrovascular disease and respiratory diseases
6. Patients in whom rapid sequence induction is indicated

Primary outcomes:
measure: Laryngeal exposure
timeFrame: Through study completion, period of 1 year
measure: Time required for intubation
timeFrame: Through study completion, period of 1 year
Secondary outcomes:
measure: Number of intubation attempts
timeFrame: Through study completion, period of 1 year
measure: Effort during laryngoscopy
timeFrame: Through study completion, period of 1 year
measure: Complications arising from intubation
timeFrame: Through study completion, period of 1 year
measure: Airway trauma
timeFrame: Through study completion, period of 1 year
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan
Study officials:
affiliation: University of Malaya
name: Samuel E H Tsan, MD, BMedSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsan SEH, Lim SM, Abidin MFZ, Ganesh S, Wang CY. Comparison of Macintosh Laryngoscopy in Bed-up-Head-Elevated Position With GlideScope Laryngoscopy: A Randomized, Controlled, Noninferiority Trial. Anesth Analg. 2020 Jul;131(1):210-219. doi: 10.1213/ANE.0000000000004349.