ObesityNCT03678246
Low Skill Fibreoptic Glottis View in Obese Patients: Ramp vs Supine Sniffing Air Position
A study testing Ramped position and Supine position in people with Obesity, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Aims: The investigators are employing a feasibility study to determine whether fibreoptic view of the glottis (vocal cords) during low skill fibreoptic intubation (FOI) via a laryngeal mask airway (LMA) in obese and severely obese patients is appropriate and feasible for future full-scale research. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Ramped position and Supine position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Jul 2018to 30 Nov 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- obese and severely obese patients (BMI ≥30, and ≥35 but <40 kg/m2, respectively) undergoing elective bsurgery under general anaesthesia who require endotracheal intubation.
Who cannot join
- Morbidly obese patients (BMI ≥40 kg/m2)
- Patients with history of previous difficult endotracheal intubation
- Patients with two or more predictors of difficult face or laryngeal mask ventilation, or difficult intubation or the combination of both
- Mallamapatti score III-IV
- Interdental distance <3cm
- Thyromental distance <6cm
Show all 15Show fewer
- Moderate to severe limitation of neck movement
- Previous head and neck radiotherapy or surgery
- Supraglottic lesion
- Patients with loose teeth
- Patients with ASA grade III (other than due to obesity) and grade IV are excluded from the study
- Patients needing a rapid sequence induction for rapid securement of the airway e.g. patients with symptoms of reflux (>1 episode per week), not starved as per standard nil by mouth guidelines, hiatus hernia, previous gastric surgery
- Pregnant women
- Patients below the age of 21 years old
- Patients unfit to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Aims: The investigators are employing a feasibility study to determine whether fibreoptic view of the glottis (vocal cords) during low skill fibreoptic intubation (FOI) via a laryngeal mask airway (LMA) in obese and severely obese patients is appropriate and feasible for future full-scale research. Obese, and severely and morbidly patients in Asia are classed as body mass index (BMI) of ≥ 30, ≥35 and ≥40 kg/m2, respectively.
Read the detailed description
Aims: The investigators are employing a feasibility study to determine whether fibreoptic view of the glottis (vocal cords) during low skill fibreoptic intubation (FOI) via a laryngeal mask airway (LMA) in obese and severely obese patients is appropriate and feasible for future full-scale research. Obese, and severely and morbidly patients in Asia are classed as body mass index (BMI) of ≥ 30, ≥35 and ≥40 kg/m2, respectively.
Hypothesis: The glottis view during low skill FOI in obese and severely obese patients (BMI ≥30, and BMI ≥35 <40 kg/m2) is better in the ramp than in the standard supine 'sniffing air' position. Low skill FOI is a term for FOI via an LMA.
Methodology: As a feasibility study, the investigators will recruit 18 adult patients scheduled for elective surgery in obese and severely obese patients requiring tracheal intubation. A non-randomized cross over design in selected. The investigators will assess acceptability, implementation and practicality of such a study and also set criteria for success of this feasibility study.
Importance of proposed research: Obese patients present many anaesthetic challenges. The ramp position facilitates easier tracheal intubation and prolongs apnoea time. In cases of failed intubation, guidelines recommend insertion of an LMA to faciliate ventilation and oxygenation, allowing the option of low skill FOI to secure the airway. It may be performed in unanticipated difficult airway ('rescue' intubation after failed intubation by conventional techniques) and so may decrease patient morbidity and mortality. There is a knowledge gap regarding whether the glottis view during low skill FOI is superior in the ramp or standard supine sniffing position. It will help determine whether the study methodology and protocol needs modification and assess what changes may occur, before implementing a full-scale study. This will help form recommendations for future guidelines in difficult airway management.
Primary outcome is to measure feasibility of this study. The areas of focus addressed by this study are:
- the investigators will assess how many obese and severely obese patients we can recruit in the Pre-Operative Evaluation Clinic (PEC)
- Patient reaction and recruitment rate (accepting or declining invitation to the study)
- Patient dropout rate Integration: Previous studies evaluating FOI via the LMA have proved less straightforward than anticipated. Standard rostering of anaesthetic study members does not allocate the latter to the operating theatre where study patients are listed; this means the anaesthetic study team member needs to leave their own operating list elsewhere to deliver the study intervention leading to poor workflow. Also, the investigators used operating intubating fibrescopes, which had priority allocation to other (nonstudy) patients due to clinical reasons. In addition, the number of fibrescopes was greatly reduced due to maintenance and repair work. As such, our study protocol incorporates different workflows. As soon as a participant is recruited, the investigators will inform the roster consultant to allocate one of the anaesthetic study member to the operating theatre where a participant is listed to improve workflow. The investigators will also use grant funded disposable fibrescopes and grant funded fibrescope monitor. Assessment will be made of:
- Percentage of lists that contain study participants that have an allocated study team member, aiming for 80% allocation.
- Any workflow availability. Practicality: The investigators will assess for any difficulties when the patient is changed from a ramp to standard supine sniffing position by a coordinated team effort by theatre personnel. Secondary outcome measures will evaluate the technique of FOI via the LMA in our study population, comparing ramp and standard 'sniffing air' positions.
- Success of LMA insertion rate (after LMA insertion, an adequate capnography trace is obtained under study ventilation parameters, whilst in ramp position)
- LMA insertion times (time from picking up the LMA for insertion until adequate capnography trace is obtained, whilst in ramp position)
- Fibreoptic intubation times (time from picking up the fibrescope, after the patient has been place in the standard supine sniffing position, until adequate capnography trace is obtained)
- Airway manoeuvers to optimize glottis view
- Any complications
- Conditions
- Obesity
- Being tested
- Ramped position, Supine position
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramped positionProcedure or surgery
LSFOI glottis view
Supine positionProcedure or surgery
LSFOI glottis view
| Study group | Role | What they receive |
|---|---|---|
| LSFOI (Ramped) | Experimental | LSFOI (Ramped) Receives: Procedure: Ramped position; Procedure: Supine position |
| LSFOI (Supine) | Active comparator | LSFOI (Supine) Receives: Procedure: Ramped position; Procedure: Supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility study
patient recruitment rate and ability to complete the study
Measured: 6 months
Secondary outcomes (6)
Positioning challenges
descriptive scale with free text comments on difficulties encountered during positioning from ramped to supine
Measured: 6 months
Success of LMA insertion rate
Success of LMA insertion rate with number of attempts stated
Measured: 6 months
LMA insertion times
LMA insertion times
Measured: 6 months
Fibreoptic intubation times
Fibreoptic intubation times
Measured: 6 months
Airway manoeuvres to optimize glottis view
options include jaw thrust and withdrawal of LMA
Measured: 6 months
Any complications
descriptive scale listing the problems/complications encountered during the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start13 Jul 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Ramped vs Supine position
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678246
- Sponsor's protocol ID
- 2017-2135
- Status last verified
- May 2019
- First submitted
- 20 Aug 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Skill Fibreoptic Glottis View in Obese Patients: Ramp vs Supine Sniffing Air Position
- ClinicalTrials.gov ID
- NCT03678246
- Acronym / sponsor ID
- 2017-2135
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 Sep 2018 (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.
Aims: The investigators are employing a feasibility study to determine whether fibreoptic view of the glottis (vocal cords) during low skill fibreoptic intubation (FOI) via a laryngeal mask airway (LMA) in obese and severely obese patients is appropriate and feasible for future full-scale research. Obese, and severely and morbidly patients in Asia are classed as body mass index (BMI) of ≥ 30, ≥35 and ≥40 kg/m2, respectively.
Detailed description
Aims: The investigators are employing a feasibility study to determine whether fibreoptic view of the glottis (vocal cords) during low skill fibreoptic intubation (FOI) via a laryngeal mask airway (LMA) in obese and severely obese patients is appropriate and feasible for future full-scale research. Obese, and severely and morbidly patients in Asia are classed as body mass index (BMI) of ≥ 30, ≥35 and ≥40 kg/m2, respectively.
Hypothesis: The glottis view during low skill FOI in obese and severely obese patients (BMI ≥30, and BMI ≥35 <40 kg/m2) is better in the ramp than in the standard supine 'sniffing air' position. Low skill FOI is a term for FOI via an LMA.
Methodology: As a feasibility study, the investigators will recruit 18 adult patients scheduled for elective surgery in obese and severely obese patients requiring tracheal intubation. A non-randomized cross over design in selected. The investigators will assess acceptability, implementation and practicality of such a study and also set criteria for success of this feasibility study.
Importance of proposed research: Obese patients present many anaesthetic challenges. The ramp position facilitates easier tracheal intubation and prolongs apnoea time. In cases of failed intubation, guidelines recommend insertion of an LMA to faciliate ventilation and oxygenation, allowing the option of low skill FOI to secure the airway. It may be performed in unanticipated difficult airway ('rescue' intubation after failed intubation by conventional techniques) and so may decrease patient morbidity and mortality. There is a knowledge gap regarding whether the glottis view during low skill FOI is superior in the ramp or standard supine sniffing position. It will help determine whether the study methodology and protocol needs modification and assess what changes may occur, before implementing a full-scale study. This will help form recommendations for future guidelines in difficult airway management.
Primary outcome is to measure feasibility of this study. The areas of focus addressed by this study are:
- the investigators will assess how many obese and severely obese patients we can recruit in the Pre-Operative Evaluation Clinic (PEC)
- Patient reaction and recruitment rate (accepting or declining invitation to the study)
- Patient dropout rate Integration: Previous studies evaluating FOI via the LMA have proved less straightforward than anticipated. Standard rostering of anaesthetic study members does not allocate the latter to the operating theatre where study patients are listed; this means the anaesthetic study team member needs to leave their own operating list elsewhere to deliver the study intervention leading to poor workflow. Also, the investigators used operating intubating fibrescopes, which had priority allocation to other (nonstudy) patients due to clinical reasons. In addition, the number of fibrescopes was greatly reduced due to maintenance and repair work. As such, our study protocol incorporates different workflows. As soon as a participant is recruited, the investigators will inform the roster consultant to allocate one of the anaesthetic study member to the operating theatre where a participant is listed to improve workflow. The investigators will also use grant funded disposable fibrescopes and grant funded fibrescope monitor. Assessment will be made of:
- Percentage of lists that contain study participants that have an allocated study team member, aiming for 80% allocation.
- Any workflow availability. Practicality: The investigators will assess for any difficulties when the patient is changed from a ramp to standard supine sniffing position by a coordinated team effort by theatre personnel. Secondary outcome measures will evaluate the technique of FOI via the LMA in our study population, comparing ramp and standard 'sniffing air' positions.
- Success of LMA insertion rate (after LMA insertion, an adequate capnography trace is obtained under study ventilation parameters, whilst in ramp position)
- LMA insertion times (time from picking up the LMA for insertion until adequate capnography trace is obtained, whilst in ramp position)
- Fibreoptic intubation times (time from picking up the fibrescope, after the patient has been place in the standard supine sniffing position, until adequate capnography trace is obtained)
- Airway manoeuvers to optimize glottis view
- Any complications
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Ramped vs Supine position
| Arm | Type | Receives |
|---|---|---|
| LSFOI (Ramped) | Experimental | Procedure: Ramped position, Procedure: Supine positionLSFOI (Ramped) |
| LSFOI (Supine) | Active comparator | Procedure: Ramped position, Procedure: Supine positionLSFOI (Supine) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- obese and severely obese patients (BMI ≥30, and ≥35 but <40 kg/m2, respectively) undergoing elective bsurgery under general anaesthesia who require endotracheal intubation.
Key exclusion criteria (15 listed)
- Morbidly obese patients (BMI ≥40 kg/m2)
- Patients with history of previous difficult endotracheal intubation
- Patients with two or more predictors of difficult face or laryngeal mask ventilation, or difficult intubation or the combination of both
- Mallamapatti score III-IV
- Interdental distance <3cm
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 |
|---|---|---|
| Ramped positionLSFOI glottis view | Procedure or surgery | LSFOI (Ramped), LSFOI (Supine) |
| Supine positionLSFOI glottis view | Procedure or surgery | LSFOI (Ramped), LSFOI (Supine) |
Primary outcome
Feasibility study
Time frame: 6 months
patient recruitment rate and ability to complete the study
6 secondary outcomes
Positioning challenges
Time frame: 6 months
Success of LMA insertion rate
Time frame: 6 months
LMA insertion times
Time frame: 6 months
Fibreoptic intubation times
Time frame: 6 months
Airway manoeuvres to optimize glottis view
Time frame: 6 months
Any complications
Time frame: 6 months
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 14 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ramped position and Supine position in people with Obesity, run by Singapore General Hospital at 1 site in Singapore.
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 1 inclusion and 15 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 14 May 2019. 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 Singapore. 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?
Feasibility study (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2019.