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Comparison of the pressure of the cuff in the oral respiratory tube using two different techniques under general anesthesia during surgical procedures

Not Applicable
Completed
Conditions
Health Condition 1: null- ASA Class 1,2 and 3 patients scheduled for any elective surgical procedure under general anesthesia
Registration Number
CTRI/2018/04/013003
Lead Sponsor
Dr Alka Hasmukhhai Bhoot
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

1)Age: 18-75 years

2)Gender: male and female

3)ASA Class: 1, 2, 3

4)Patients posted for routine surgery, without any risk of aspiration or regurgitation requiring general anesthesia with orotracheal intubation

5)Duration of surgery less than 4 hours

6)Two or less than two attempts of intubation

Exclusion Criteria

1)Prone/lateral positioning for surgery

2)Recent history of upper respiratory tract infections; preoperative sore throat, hoarseness of voice or cough

3)Tracheostomised patients

4)Known airway anomalies (airway stenosis, including Downâ??s syndrome)

5)Known or suspected difficult intubation

6)Head and neck surgeries like surgery of the larynx and/or of the trachea, neck, and/or upper oesophagus

7)Pulmonary diseases (concurrent pneumonia or bronchial infection, asthma requiring inhalation medication, pulmonary malformations)

8)Fibre-optic intubation or alternative intubation technique

9)Planned postoperative ventilation in the ICU

10)Patients at risk of aspiration - Pregnant patients, full stomach.

11)Anterior cervical spine surgeries.

12)Patients having hypotension (BP < 90 mm Hg)

13)Patients with BMI > 35 kg/m2

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary aim: <br/ ><br>1) To compare endotracheal cuff pressures obtained by- manual inflation of pilot balloon (by a syringe) and direct inflation via a cuff pressure gauge. <br/ ><br>2) To evaluate changes in cuff pressure over time. <br/ ><br>Timepoint: 1. just after intubation <br/ ><br>2. at 30 mins <br/ ><br>3. at 1 hour <br/ ><br>4. at 2 hours <br/ ><br>5. at 3 hours <br/ ><br>6. at 4 hours/ just before extubation
Secondary Outcome Measures
NameTimeMethod
Secondary aim: <br/ ><br>To assess complications like sore throat, hoarseness of voice, cough, post extubation stridor which may occur as a result of overinflated ETT cuff; aspiration which may occur as a result of insufficiently inflated cuff. <br/ ><br>Timepoint: secondary outcome observed after 2 hours and 24 hours after extubation
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