NCT04258215

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

February 4, 2020

Last Update Submit

September 2, 2022

Conditions

Airway Control

Keywords

Positive pressure ventilationExtraglottic Airway Device

Outcome Measures

Primary Outcomes (2)

  • 1.PSA Ease of insertion It should be adequate and reliable [Time Frame: Assessed by the anesthesiologist within first 60 seconds of inserting the device.]

    Time taken to achieve adequate airway

    Assessed by the anesthesiologist within first 60 seconds of inserting the device.

  • Satisfactory positive pressure ventilation: Maximum airway inflation pressure

    Maximum airway inflation pressure that can be achieved before a significant leak becomes apparent must exceed 14 cm water pressure.

    Assessed by the anesthesiologist within first 120 seconds of inserting the device.

Secondary Outcomes (1)

  • Watching for possible unanticipated serious side effects from airway usage

    Within the first 24 hours

Study Arms (1)

Positive pressure achieved with PSA

EXPERIMENTAL

Maximum airway inflation pressure achievable before a significant leak occurs.

Device: Experimental: Routine positive pressure airway management.

Interventions

Experimental: Routine positive pressure airway management.DEVICE

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.

Positive pressure achieved with PSA

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Anatomical sizing criterion

You may not qualify if:

  • Emergency participants Suspected full stomach
  • Mentally incompetent patients
  • Patients who are requiring head and neck surgery
  • Morbidly obese patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hull University Teaching Hospital, Castle Hill Hospital.

Hull, East Riding Of Yorkshire, HU16 5JQ, United Kingdom

Location

Related Publications (3)

  • Miller DM, Light D. Laboratory and clinical comparisons of the Streamlined Liner of the Pharynx Airway (SLIPA) with the laryngeal mask airway. Anaesthesia. 2003 Feb;58(2):136-42. doi: 10.1046/j.1365-2044.2003.02962.x.

    PMID: 12562409BACKGROUND

  • Yamanaka H, Hayashi Y, Watanabe Y, Uematu H, Mashimo T. Prolonged hoarseness and arytenoid cartilage dislocation after tracheal intubation. Br J Anaesth. 2009 Sep;103(3):452-5. doi: 10.1093/bja/aep169. Epub 2009 Jun 25.

    PMID: 19556269RESULT

  • Miller DM, Lavelle M. A streamlined pharynx airway liner: a pilot study in 22 patients in controlled and spontaneous ventilation. Anesth Analg. 2002 Mar;94(3):759-61; table of contents. doi: 10.1097/00000539-200203000-00052.

    PMID: 11867412RESULT

Study Officials

  • Narendra Pai

    Hull University Teaching Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

  • Donald Miller

    Hull University Teaching Hospital NHS Trust

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Pilot study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

May 1, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)