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

September 13, 2018 updated by: Samuel E H Tsan, MD, BMedSc, University of Malaya

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
        • University Malaya Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, period of 1 year
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
Through study completion, period of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of intubation attempts
Time Frame: Through study completion, period of 1 year
Through study completion, period of 1 year
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.
Through study completion, period of 1 year
Complications arising from intubation
Time Frame: Through study completion, period of 1 year
Incidence of hypoxia, hypotension, or esophageal intubation. Yes/no categories.
Through study completion, period of 1 year
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.
Through study completion, period of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samuel E H Tsan, MD, BMedSc, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017112-5770

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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