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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03357679
Recruitment Status : Completed
First Posted : November 30, 2017
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel E H Tsan, MD, BMedSc, University of Malaya

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.

Condition or disease Intervention/treatment Phase
Bed up Head Elevated Intubation Position Procedure: Tracheal intubation Device: Glidescope assisted tracheal intubation Device: Bed up head elevated tracheal intubation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Primary Purpose: Treatment
Official Title: Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation: A Randomised, Controlled, Non-inferiority Trial
Actual Study Start Date : December 26, 2017
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : September 13, 2018

Arm Intervention/treatment
Active Comparator: Bed up head elevated intubation
Patients positioned in the bed up head elevated position, followed by tracheal intubation
Procedure: Tracheal intubation
Intubation of the trachea with endotracheal tube

Device: Bed up head elevated tracheal intubation
Use of the Macintosh laryngoscope blade size 3

Active Comparator: Glidescope assisted intubation
Glidescope is used for laryngoscopy, followed by intubation
Procedure: Tracheal intubation
Intubation of the trachea with endotracheal tube

Device: Glidescope assisted tracheal intubation
With the use of the Glidescope video laryngoscope, the trachea will be intubated with the endotracheal tube




Primary Outcome Measures :
  1. Laryngeal exposure [ Time Frame: Through study completion, period of 1 year ]
    Measured 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.

  2. Time required for intubation [ Time Frame: Through study completion, period of 1 year ]
    Measured from the time the tip of the laryngoscope passes through the incisors to the time of the first recorded wave of capnography


Secondary Outcome Measures :
  1. Number of intubation attempts [ Time Frame: Through study completion, period of 1 year ]
  2. Effort during laryngoscopy [ Time Frame: Through study completion, period of 1 year ]
    Assessed based on a visual analogue scale, with 10 being the strongest effort, and 1 being the least effort required.

  3. Complications arising from intubation [ Time Frame: Through study completion, period of 1 year ]
    Incidence of hypoxia, hypotension, or esophageal intubation. Yes/no categories.

  4. Airway trauma [ Time Frame: Through study completion, period of 1 year ]
    Whether injury occurs to the lips, tongue, teeth, and other structures in the oropharyngeal area. Yes/no categories.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357679


Locations
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Malaysia
University Malaya Medical Centre
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Samuel E H Tsan, MD, BMedSc University of Malaya
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samuel E H Tsan, MD, BMedSc, Doctor, University of Malaya
ClinicalTrials.gov Identifier: NCT03357679    
Other Study ID Numbers: 2017112-5770
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel E H Tsan, MD, BMedSc, University of Malaya:
Bed up head elevated position
Glidescope assisted tracheal intubation
Laryngeal exposure
Time to intubation