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Does reduction of pressure in the cuff of a laryngeal mask airway (device to protect the airway during anaesthesia) help to decrease complications after anaesthesia?

Does cuff pressure monitoring reduce post-operative pharyngo-laryngeal adverse events after LMA-ProSeal insertion? â?? A randomized trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/12/004234
Enrollment
120
Registered
2013-12-23
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- adult patients (aged 18 to 80 years) with ASA physical status I, II and III scheduled to receive general anesthesia with LMA-ProSeal for short duration elective procedures

Interventions

Intervention1: pressure-monitored group: LMA-ProSeal cuff pressure monitoring and limiting pressure below 60 cm H2O Control Intervention1: control group: LMA-ProSeal cuff pressure measurement without

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: adult patients (aged 18 to 80 years) with ASA physical status I, II and III scheduled to receive general anesthesia with LMA-ProSeal for short duration elective procedures like orthopedic, urologic and breast surgeries.

Exclusion criteria

Exclusion criteria: any contraindication for the use of LMA (such as morbid obesity, gastro-esophageal reflux or previous upper abdominal surgery) or recent (within 7 days) history of upper respiratory tract infection.

Design outcomes

Primary

MeasureTime frame
The incidence of any pharyngo-laryngeal complication (sore throat, dysphagia, dysphonia)Timepoint: at any of 1, 2 or 24 hours postoperatively

Secondary

MeasureTime frame
Incidence of individual complications - sore throat, dysphagia, dysphoniaTimepoint: at individual time points of 1, 2 and 24 hrs post-operatively

Countries

India

Contacts

Public ContactPRIYA RANGANATHAN

Tata Memorial Centre

DRPRIYARANGANATHAN@GMAIL.COM912224177059

Outcome results

None listed

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