MedPath

A research to compare the use of two medical devices (C- MAC D-Blade videolaryngoscope and McCoy laryngoscope), in patients with restricted neck mobility.

Phase 4
Registration Number
CTRI/2016/08/007139
Lead Sponsor
Director Principal of Government Medical College and Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
54
Inclusion Criteria

1. Age group of 18 to 60 years

2. ASA (American Society of Anaesthesiologists) physical status I and II

3. Patients undergoing elective surgery requiring endotracheal intubation under general anaesthesia

Exclusion Criteria

1. Morbid obesity

2. Patients with anticipated difficult airway[Airway Difficulty Score >8]

3. Patients at increased risk of pulmonary aspiration such as gastroesophageal reflux disease(GERD), peptic ulcer disease

4. Previous upper gastrointestinal surgery

5. Pregnancy

6. Coagulopathy or history of anticoagulant use

7. Cardiorespiratory or cerebrovascular disease

8. Cervical spine pathology

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate and compare C-MAC D-Blade videolaryngoscope with McCoy laryngoscope for time taken for tracheal intubation in patients with simulated restricted neck mobility undergoing elective surgery under general anaesthesia.Timepoint: Outcome (TTI) will be assessed at point of appearance of square wave capnograph on monitor after the introduction of device in mouth and subsequent endotracheal tube placement. <br/ ><br> <br/ ><br>[TTI- defined as time of introduction of device in mouth to the confirmation of endotracheal tube placement by a square wave capnograph on the monitor]. <br/ ><br> <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
To Compare the: <br/ ><br>1. Laryngeal view <br/ ><br>2. Number of attempts <br/ ><br>3. Heart Rate (HR),Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Continuous electrocardiogram (ECG), oxygen saturation (SPO2) and End Tidal carbon dioxide level (ETCO2). <br/ ><br>4. Intraoperative findings and post operative adverse eventsTimepoint: 1. Laryngeal view: immediately after introduction of laryngoscope <br/ ><br>2. HR, NIBP, ECG, SPO2 and ETCO2: just before intubation, immediately after intubation, 1minute interval for next 5 minutes after intubation, 5 minute interval till 15 minutes after intubation <br/ ><br>3.Intra/postoperative findings and adverse events: immediately after endotracheal intubation, immediately after extubation of tracheal tube, 2 hours after extubation of tracheal tube, 12 hours after extubation of tracheal tube <br/ ><br>
© Copyright 2025. All Rights Reserved by MedPath