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A study to evaluate the air pressure inside the cuff of device which is inserted in the patients throat.

To determine the trend of intracuff pressure after successful placement of the Ambu Auragain™ supraglottic airway device and inflating it according to the manufacturer’s recommendations: a single arm prospective observational pilot study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/09/058156
Enrollment
50
Registered
2023-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Nil: Not Applicable Control Intervention1: Nil: Not Applicable

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 years or above 2. Undergoing anaesthesia for procedures lasting 30 minutes or more. 3. We will recruit only those patients who require the use of a supraglottic airway device and muscle paralysis for their anaesthetic management e.g., Breast surgery, TURBT etc. 4. Adults undergoing surgery in the supine position or any position in which the patient is on their back, with neck slightly rotated to one side.

Exclusion criteria

Exclusion criteria: 1. Patients refusing consent. 2. Patients undergoing Head and Neck surgery. 3. Positions other than supine or lithotomy i.e positions where the patient is not lying on their back. 4. Patients requiring any neck manipulations during surgery e.g., Insertion of Chemo Port.

Design outcomes

Primary

MeasureTime frame
To note the intracuff pressure and maintain it less than 44 mm of Hg (60 cm of water)Timepoint: Immediately after supraglottic device insertion and cuff inflation and every 15 mins thereafter—

Secondary

MeasureTime frame
1. To measure the incidence and severity of post-operative sore-throat at 24 hours in patients undergoing procedures with a supraglottic airway device using a 10 point numerical scale. This can be classified using a Likert scale as- Mild- NRS 1-3 Moderate-NRS 4-6 Severe- NRS 7-10 2. Other complications like hoarseness of voice, dysphagia or any other complications at 24 hours will also be noted. Timepoint: 24 hours after the procedure—

Countries

India

Contacts

Public ContactDr Vipul Tripathi

TATA MEMORIAL HOSPITAL

jesonrdoctor@gmail.com9820054956

Outcome results

None listed

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