Bed up Head Elevated Intubation PositionNCT03357679
Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation
A study testing Tracheal intubation, Glidescope assisted tracheal intubation and Bed up head elevated tracheal intubation in people with Bed up Head Elevated Intubation Position, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bed up Head Elevated Intubation Position
- What is being tested?
- Tracheal intubation, Glidescope assisted tracheal intubation and Bed up head elevated tracheal intubation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteMalaysia
- Study dates
- 26 Dec 2017to 13 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective surgeries under general anaesthesia
- Patients aged from 18 years old to 75 years old
- Patients who are able to give informed consent
Who cannot join
- Patients with airway obstruction
- Patients with contraindications to neck extension
- Patients with small mouth opening (<3 cm)
- BMI > 35 kg/m3
- Patients with ischemic heart disease, cerebrovascular disease and respiratory diseases
- Patients in whom rapid sequence induction is indicated
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: 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.
- Conditions
- Bed up Head Elevated Intubation Position
- Being tested
- Tracheal intubation, Glidescope assisted tracheal intubation, Bed up head elevated tracheal intubation
- Keywords
- Bed up head elevated position, Glidescope assisted tracheal intubation, Laryngeal exposure, Time to intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubationProcedure or surgery
Intubation of the trachea with endotracheal tube
Glidescope assisted tracheal intubationDevice
With the use of the Glidescope video laryngoscope, the trachea will be intubated with the endotracheal tube
Bed up head elevated tracheal intubationDevice
Use of the Macintosh laryngoscope blade size 3
| Study group | Role | What they receive |
|---|---|---|
| Bed up head elevated intubation | Active comparator | Patients positioned in the bed up head elevated position, followed by tracheal intubation Receives: Procedure: Tracheal intubation; Device: Bed up head elevated tracheal intubation |
| Glidescope assisted intubation | Active comparator | Glidescope is used for laryngoscopy, followed by intubation Receives: Procedure: Tracheal intubation; Device: Glidescope assisted tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngeal exposure
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.
Measured: Through study completion, period of 1 year
Time required for intubation
Measured from the time the tip of the laryngoscope passes through the incisors to the time of the first recorded wave of capnography
Measured: Through study completion, period of 1 year
Secondary outcomes (4)
Number of intubation attempts
Measured: Through study completion, period of 1 year
Effort during laryngoscopy
Assessed based on a visual analogue scale, with 10 being the strongest effort, and 1 being the least effort required.
Measured: Through study completion, period of 1 year
Complications arising from intubation
Incidence of hypoxia, hypotension, or esophageal intubation. Yes/no categories.
Measured: Through study completion, period of 1 year
Airway trauma
Whether injury occurs to the lips, tongue, teeth, and other structures in the oropharyngeal area. Yes/no categories.
Measured: Through study completion, period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start26 Dec 2017
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bed up Head Elevated Intubation PositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel E H Tsan, MD, BMedSc, University of Malaya
- Investigators
- Samuel E H Tsan, MD, BMedSc, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357679
- Sponsor's protocol ID
- 2017112-5770
- Status last verified
- Sep 2018
- First submitted
- 17 Nov 2017
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31348051
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation: A Randomised, Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03357679
- Acronym / sponsor ID
- 2017112-5770
- Conditions
- Bed up Head Elevated Intubation Position
- Keywords
- Bed up head elevated position, Glidescope assisted tracheal intubation, Laryngeal exposure, Time to intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bed up head elevated intubation | Active comparator | Procedure: Tracheal intubation, Device: Bed up head elevated tracheal intubationPatients positioned in the bed up head elevated position, followed by tracheal intubation |
| Glidescope assisted intubation | Active comparator | Procedure: Tracheal intubation, Device: Glidescope assisted tracheal intubationGlidescope is used for laryngoscopy, followed by intubation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective surgeries under general anaesthesia
- Patients aged from 18 years old to 75 years old
- Patients who are able to give informed consent
Key exclusion criteria (6 listed)
- Patients with airway obstruction
- Patients with contraindications to neck extension
- Patients with small mouth opening (<3 cm)
- BMI > 35 kg/m3
- Patients with ischemic heart disease, cerebrovascular disease and respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracheal intubationIntubation of the trachea with endotracheal tube | Procedure or surgery | Bed up head elevated intubation, Glidescope assisted intubation |
| Glidescope assisted tracheal intubationWith the use of the Glidescope video laryngoscope, the trachea will be intubated with the endotracheal tube | Device | Glidescope assisted intubation |
| Bed up head elevated tracheal intubationUse of the Macintosh laryngoscope blade size 3 | Device | Bed up head elevated intubation |
Primary outcome
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.
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
4 secondary outcomes
Number of intubation attempts
Time frame: Through study completion, period of 1 year
Effort during laryngoscopy
Time frame: Through study completion, period of 1 year
Complications arising from intubation
Time frame: Through study completion, period of 1 year
Airway trauma
Time frame: Through study completion, period of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Derived from this study: PubMed 31348051Tsan 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel E H Tsan, MD, BMedSc principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal intubation, Glidescope assisted tracheal intubation and Bed up head elevated tracheal intubation in people with Bed up Head Elevated Intubation Position, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laryngeal exposure (time frame: Through study completion, period of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03357679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.