Two positions for intubation with videolaryngoscope in obese patients

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/05/053300
• Lead Sponsor: University College of Medical Siences

Brief Summary

Study title: Comparison of Ramped versus Sniffing position for orotracheal intubation usingvideolaryngoscope in obese patients.Rationale and Aims: Obesity is associated with an anticipated difficult airway. Patientpositioning is a very important and often neglected aspect of airway management in obese withthe ramped or head elevated laryngoscopy position being the most suitable for directlaryngoscopy. However, the best position for videolaryngoscopy in obese patients is yet to beresearched. This study is aimed to compare ramped position versus sniffing position fororotracheal intubation using videolaryngoscope in obese patients in terms of time required forsuccessful intubation, success rate in the first intubation attempt, difficulty in mask ventilation,laryngoscopy time, tube insertion time, intubation difficulty score, complications (oesophagealintubations, intubation failures, incidence of desaturation, trauma, sore throat and hoarseness).Methods: This prospective randomised study will be conducted between May 2023 andNovember 2024 after obtaining ethical approval and written informed consent from all patients.A total of 30 (15 in each group) consenting patients >18 years of age belonging to either sex,ASA physical status I-III having BMI>30 kg/m2 with Mallampatti class I-IV airways scheduledfor elective surgical procedures will be enrolled. Patients requiring awake intubation, rapidsequence intubation, having bleeding diathesis, neck mass, neck irradiation, restricted neckmobility, cervical spine injury/pathology, oral cavity growths or h/o upper respiratory tractinfection in the last 1 month will be excluded. Patients will be randomly allocated to eithergroup R (ramped position) or group S (sniffing position) based on a computer-generatedrandom number table. General anaesthesia will be induced as per standard protocol. Aftercomplete muscle relaxation, Tuoren video-laryngoscope will used for intubation.Sample size estimation and Statistical Analysis: Considering the total intubation time as 22.5± 6.2 s in the ramped position and 40.9 ± 9.0 s in sniffing position as per a previous study (7),to estimate a clinically important difference of 10 s in mean intubation time at α = 5% andpower = 90%, a sample of 15 patients is required in each group. So, we propose to include total30 cases, 15 in each group. Data will be entered on a spreadsheet, cleaned and analysed usingSPSS version 20.0. One time measured quantitative parameters between the groups will becompared by unpaired t-test or Mann Whitney U-test depending upon nature of data.Qualitative parameters will be compared by χ2testor Fisher’s exact test. A P-value<0.05 willbe taken as significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-06
• Study Completion: 2024-11-30
• Last Update Posted: 2024-11-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

A total of 30 (15 in each group) consenting patients >18 years of age belonging to either sex, ASA physical status I-III having BMI>30 kg/m2 with Mallampatti class I-IV airways scheduled for elective surgical procedures requiring general anaesthesia with tracheal intubation will be enrolled.

Exclusion Criteria

• Cases where awake intubation is planned (without induction of anaesthesia and muscle relaxation).
• Patients requiring rapid sequence intubation (full stomach, pregnant, emergency, gastroesophageal reflux disease, emergency laparotomy).
• Patients with bleeding diathesis.
• Patients with neck mass, neck irradiation, restricted neck mobility, cervical spine injury/pathology, oral cavity growths.
• Patients with h/o upper respiratory tract infection in the last 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time required for successful intubation	Once after intubation is done

Secondary Outcome Measures

Name	Time	Method
Success rate in the first intubation attempt	Difficulty in mask ventilation

Trial Locations

Locations (1)

University College of Medical Sciences; 🇮🇳 East, DELHI, India

University College of Medical Sciences

🇮🇳East, DELHI, India

DR RASHMI SALHOTRA

Principal investigator

9911317334

rashmichabra@yahoo.com