Health Condition 1: Z468- Encounter for fitting and adjustment of other specified devices
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Jawaharlal Institute of Postgraduate Medical Education and Research