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Study to check if the air pressure in breathing tube cuffs is within the safe range during anaesthesia.

To determine the incidence of inappropriate cuff inflation pressures in ProSeal laryngeal mask airway and endotracheal tube: A prospective observational study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/112370
Enrollment
132
Registered
2026-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: Z468- Encounter for fitting and adjustment of other specified devices

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Scheduled for elective/ emergency surgery under general anaesthesia in supine position.

Exclusion criteria

Exclusion criteria: Cuff inflated with saline or local anaesthetics, Cuff design other than high volume low pressure cuff, Microlaryngeal tubes, Tracheal anomalies or previous tracheal surgery, Pregnancy, Fresh gas flow with nitrous oxide.

Design outcomes

Primary

MeasureTime frame
Incidence of inappropriate cuff inflation pressure (under-inflation, adequate inflation, and over-inflation) in ProSeal Laryngeal Mask Airway and Endotracheal Tube as determined by cuff pressure measurement.Timepoint: Within 1 2 hours following insertion of the airway device (intubation/LMA placement).

Secondary

MeasureTime frame
Volume of air used for cuff inflation and its association with measured cuff pressure.Timepoint: Within 1 2 hours following insertion of the airway device (intubation/LMA placement).;Cuff pressure (cm H2O) in ProSeal LMA and Endotracheal Tube.Timepoint: Within 1 2 hours following insertion of the airway device (intubation/LMA placement).;Audible or palpable leak (yes or no), Etco2 (mmHg)& capnogram, Peak airway pressure(cmH2O) , set and expired tidal volume (ml) will be notedTimepoint: Within 1 2 hours following insertion of the airway device (intubation/LMA placement).

Countries

India

Contacts

Public ContactDr. P Sakthirajan

Jawaharlal Institute of Postgraduate Medical Education and Research

sakthiab8@gmail.com8903468132

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026