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PSA (Pharachute Supralaryngeal Airway) for Positive Pressure Ventilation (PPV)

NCT04258215 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-09-07

No results posted yet for this study

Summary

The Pharachute Supralaryngeal Airway (PSA) is an extraglottic airway device (EAD) for routine use in anaesthesia.

The plan is to do a pilot study on a minimum of 20 and maximum of 30 participants whose fitness status is ASA 1 or 2 for whom this type of airway management is routinely used. When the participants are asleep the airway will be inserted, with ease of insertion and satisfactory positive pressure ventilation assessed. This will be indicated by minimal threshold leak from the breathing system and the seal pressure that can be achieved. Any side-effects will be assessed post-operatively.

Conditions

  • Airway Control

Interventions

DEVICE

Experimental: Routine positive pressure airway management.

The use of the PSA extraglottic airway for routine general anesthesia will be assessed for quality of airway management by measuring the seal pressure when using the device in 20 participants.

Sponsors & Collaborators

  • Hull University Teaching Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Narendra Pai · Hull University Teaching Hospital NHS Trust

  • Donald Miller · Hull University Teaching Hospital NHS Trust

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04258215 on ClinicalTrials.gov