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Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation

Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation: A Randomised, Controlled, Non-inferiority Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03357679
Enrollment
138
Registered
2017-11-30
Start date
2017-12-26
Completion date
2018-09-13
Last updated
2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bed up Head Elevated Intubation Position

Keywords

Bed up head elevated position, Glidescope assisted tracheal intubation, Laryngeal exposure, Time to intubation

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.

Interventions

PROCEDURETracheal intubation

Intubation of the trachea with endotracheal tube

DEVICEGlidescope assisted tracheal intubation

With the use of the Glidescope video laryngoscope, the trachea will be intubated with the endotracheal tube

DEVICEBed up head elevated tracheal intubation

Use of the Macintosh laryngoscope blade size 3

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Investigator is blinded to the initial laryngeal exposure during the sniffing position, but is unblinded during assessment of laryngeal exposure in either the bed up head elevated position or glidescope assisted tracheal intubation

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Laryngeal exposureThrough study completion, period of 1 yearMeasured by Percentage of Glottic Opening (POGO) score. A 100% POGO score refers to visualisation of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% refers to no visualisation of laryngeal structures. A 100% score is optimal.
Time required for intubationThrough study completion, period of 1 yearMeasured from the time the tip of the laryngoscope passes through the incisors to the time of the first recorded wave of capnography

Secondary

MeasureTime frameDescription
Number of intubation attemptsThrough study completion, period of 1 year
Effort during laryngoscopyThrough study completion, period of 1 yearAssessed based on a visual analogue scale, with 10 being the strongest effort, and 1 being the least effort required.
Complications arising from intubationThrough study completion, period of 1 yearIncidence of hypoxia, hypotension, or esophageal intubation. Yes/no categories.
Airway traumaThrough study completion, period of 1 yearWhether injury occurs to the lips, tongue, teeth, and other structures in the oropharyngeal area. Yes/no categories.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026