NCT06580652

Brief Summary

The investigators aim to investigate the real life volumes of air delivered to the lungs when rescuers deliver these breaths by hand as part of resuscitation attempts during cardiac arrest. The study will compare the volumes achieved using different devices which are routinely used to provided an airway during routine cardiac arrest care. Volumes will be measured using a small non intrusive device which sits in the airway circuit and measures flow of air in real time. The patients chosen for this study will be those already recruited to an ongoing trial (AIRWAYS-3) assessing the outcomes for patients suffering in hospital cardiac arrest based on airway device used.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Aug 2024Aug 2026

First Submitted

Initial submission to the registry

March 12, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

November 21, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

March 12, 2024

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tidal Volume

    The mean tidal volume achieved during cardiac arrest treatment

    assessed from the initiation of advanced airway management to the cessation of the resuscitation treatment (Return of spontaneous circulation or death). Through completion of data collection, ranging between minutes to 1 hour.

Secondary Outcomes (3)

  • Mean leak

    assessed from the initiation of advanced airway management to the cessation of the resuscitation treatment (Return of spontaneous circulation or death). Through completion of data collection, ranging between minutes to 1 hour.

  • inspiratory time

    assessed from the initiation of advanced airway management to the cessation of the resuscitation treatment (Return of spontaneous circulation or death). Through completion of data collection, ranging between minutes to 1 hour.

  • Expiratory time

    assessed from the initiation of advanced airway management to the cessation of the resuscitation treatment (Return of spontaneous circulation or death). Through completion of data collection, ranging between minutes to 1 hour.

Other Outcomes (4)

  • Respiratory rate

    assessed from the initiation of advanced airway management to the cessation of the resuscitation treatment (Return of spontaneous circulation or death). Through completion of data collection, ranging between minutes to 1 hour.

  • Smallest tidal volume

    assessed from the initiation of advanced airway management to the cessation of the resuscitation treatment (Return of spontaneous circulation or death). Through completion of data collection, ranging between minutes to 1 hour.

  • largest tidal volume

    assessed from the initiation of advanced airway management to the cessation of the resuscitation treatment (Return of spontaneous circulation or death). Through completion of data collection, ranging between minutes to 1 hour.

  • +1 more other outcomes

Study Arms (2)

Tracheal Tube

participants in cardiac arrest in whom a tracheal tube is used as the airway device

Supraglottic Airway

participants in cardiac arrest in whom a supraglottic airway is used as the airway device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have suffered a cardiac arrest whilst an in patient.

You may qualify if:

  • As per AIRWAYS-3 trial:
  • In-hospital cardiac arrest, attended by the hospital cardiac arrest team in response to a cardiac arrest call (2222 or equivalent), and when a clinician permitted to undertake both tracheal intubation and supraglottic airway placement (so that either intervention can be delivered) is present
  • Undergoing resuscitation and requiring advanced airway management in the opinion of the trained clinician responsible for randomisation

You may not qualify if:

  • As per AIRWAYS-3 trial
  • Patients who have a cardiac arrest outside hospital and who are transported to the hospital in ongoing cardiac arrest
  • People who are not a hospital inpatient (e.g. visitor, relative, staff or outpatient)
  • Patients who are already tracheally intubated at the time of eligibility assessment
  • Patients known to be pregnant
  • Patients with a functioning tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal United Hospital Bath

Bath, Banes, BA13NG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Kelly Spencer

    Royal United Hosptial Bath

    STUDY CHAIR

Central Study Contacts

James Penketh

CONTACT

Jerry Nolan

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2024

First Posted

August 30, 2024

Study Start

August 28, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

November 21, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations