Low Skill Fibreoptic Glottis View in Obese Patients: Ramp vs Supine Sniffing Air Position

NCT03678246 | Completed FDA Device

• 1 other identifier: 2017-2135
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. Obese, and severely and morbidly patients in Asia are classed as body mass index (BMI) of ≥ 30, ≥35 and ≥40 kg/m2, respectively.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Feasibility study

  patient recruitment rate and ability to complete the study

  6 months

Secondary Outcomes (6)

• Positioning challenges

  6 months

• Success of LMA insertion rate

  6 months

• LMA insertion times

  6 months

• Fibreoptic intubation times

  6 months

• Airway manoeuvres to optimize glottis view

  6 months

Study Arms (2)

LSFOI (Ramped)

EXPERIMENTAL

LSFOI (Ramped)

Procedure: Ramped position; Procedure: Supine position

LSFOI (Supine)

ACTIVE COMPARATOR

LSFOI (Supine)

Procedure: Ramped position; Procedure: Supine position

Interventions

Ramped position PROCEDURE

LSFOI glottis view

LSFOI (Ramped); LSFOI (Supine)

Supine position PROCEDURE

LSFOI glottis view

LSFOI (Ramped); LSFOI (Supine)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• obese and severely obese patients (BMI ≥30, and ≥35 but \<40 kg/m2, respectively) undergoing elective bsurgery under general anaesthesia who require endotracheal intubation.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Obesity

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Images are reviewed by two senior anaesthetists who is not directly involved in the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Ramped vs Supine position

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: September 19, 2018
• Study Start: July 13, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

SG (1)