Pre-Operative Airway Assessment of Patients With Morbid Obesity

NCT04542187 | Completed

• 1 other identifier: 2017/599
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Backround:The incidence of difficulty in laryngoscopy and endotracheal intubation is more common in obese patients. There are conflicting data on factors predicting difficult intubation. Also, these predictors are uncertain when video laryngoscopy (VL) is used. In this study we aim to investigate the correlation between airway assessment tests, anthropometric measurements and Modified Cormack-Lehane Classification (MCLC), assessed by C-MAC-D-blade VL and predictive values for intubation difficulty in class-III patients. Methods: This prospective observational study was performed in 121 obese patients (Body mass index (BMI)≥45kg/m2) undergoing bariatric surgery. BMI, modified mallampati scores (MMS), thyromental distance (TMD), sternomental distance (SMD), interincisor distance (IID), and neck, waist, and chest circumference were all recorded preoperatively. Endotracheal intubations were performed with a C-MAC D-blade VL. The glottic view and intubation difficulty were determined according to the MCLC. MCLC I-IIa was recorded as the group with no risk of a difficult intubation, the MCLC IIb-III was recorded as the group with risk of a difficult intubation and the MCLC-IV was recorded as the group with a difficult intubation. The correlation between the airway tests, anthropometric parameters and the MCLC, as well as their sensitivity and specificity in predicting the intubation difficulty based on the MCLC, were analyzed. The duration of intubation, number of attempts, external laryngeal maneuver, the equipment requirements (style, guide), and complications during intubation were recorded.

Conditions

Intubation;Difficult; Obesity, Morbid

Keywords

Intubation, airway evaluation, obesity, videolaryngoscopy

Outcome Measures

Primary Outcomes (2)

• Number of attempts for intubation

  Number of attempts required to perform successful intubation

  6 months

• Modified Cormack-Lehane classification

  It will be evaluated with videolarengoscopy

  6 months

Secondary Outcomes (1)

• Time needed for intubation

  6 months

Eligibility Criteria

• Age: 16 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

After obtaining the patients written informed consent, as a result of the power analysis, one hundred and twenty-one patients, aged 16-68 years, with a BMI ≥ 45 kg/m2, who were undergoing elective bariatric surgery were included in this study. Patients with a history of difficult airway, limited neck movements, oral-pharyngeal cancer or reconstructive surgery, cervical spinal injury and facial anomaly or scar, patients who required quick and awake endotracheal intubation, and patients who were not oriented-cooperative, were excluded from the study.

You may qualify if:

• Patients with a BMI ≥ 45 kg/m2
• Patients undergoing bariatric surgery

You may not qualify if:

• Patients with a history of difficult airway
• Patients with a limited neck movements
• Patients with a cervical spinal injury
• Patients with a facial anomaly or scar
• Patients who required quick and awake endotracheal intubation
• Patients who were not oriented-cooperative

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Serdar Demirgan, MD

  Health Science University Bağcılar Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: January 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months
• Access Criteria: no criteria

Locations

TU (1)