Singapore General Hospital
Singapore, 169608
NCT Number: NCT03678246
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Singapore, 169608
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:
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LSFOI glottis view
LSFOI glottis view
Time frame: 6 months
patient recruitment rate and ability to complete the study
Time frame: 6 months
descriptive scale with free text comments on difficulties encountered during positioning from ramped to supine
Time frame: 6 months
Success of LMA insertion rate with number of attempts stated
Time frame: 6 months
LMA insertion times
Time frame: 6 months
Fibreoptic intubation times
Time frame: 6 months
options include jaw thrust and withdrawal of LMA
Time frame: 6 months
descriptive scale listing the problems/complications encountered during the study
Singapore General Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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