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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

Comparison of endotracheal tube cuff pressures using manual vs. pressure gauge monitored technique

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013003
Enrollment
100
Registered
2018-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ASA Class 1,2 and 3 patients scheduled for any elective surgical procedure under general anesthesia

Interventions

Intervention1: Group M Inflation of ETT cuff by a syringe: Inflation of ETT cuff by a syringe with estimation of intra cuff pressure by manual palpation of pilot balloon and by auscultation with a ste

Sponsors

Dr Alka Hasmukhhai Bhoot
Lead Sponsor

Eligibility

Inclusion criteria

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

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 13) Patients with BMI > 35 kg/m2

Design outcomes

Primary

MeasureTime frame
Primary aim: 1) To compare endotracheal cuff pressures obtained by- manual inflation of pilot balloon (by a syringe) and direct inflation via a cuff pressure gauge. 2) To evaluate changes in cuff pressure over time. Timepoint: 1. just after intubation 2. at 30 mins 3. at 1 hour 4. at 2 hours 5. at 3 hours 6. at 4 hours/ just before extubation

Secondary

MeasureTime frame
Secondary aim: 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. Timepoint: secondary outcome observed after 2 hours and 24 hours after extubation

Countries

India

Contacts

Public ContactDr Alka Hasmukhbhai Bhoot

Government medical college and New civil hospital, Surat

dr26hemanginisurat@gmail.com9408709807

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026