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Respiratory Parameters Using Advanced Airways During In-hospital Cardiac Arrest

Sponsor: Royal United Hospitals Bath NHS Foundation Trust

NCT ID: NCT06580652

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 24 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
30
Started
2024-08-28
Last checked
2025-07

Plain English Summary

What is this study?

  • • Testing a new treatment for cardiac arrest
  • • Clinical study - 30 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with cardiac arrest

Where?

  • • Bath - Royal United Hospital Bath

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Patients meeting the AIRWAYS-3 inclusion criteria will be enrolled. Aged \> 18, undergoing cardiopulmonary resuscitation and a clinician present able to perform both tracheal intubation and insertion of an SGA. Patients in the emergency department, patients under 18 and pregnant patients will excluded. Patients will be treated exactly as per the AIRWAYS-3 protocol. Following randomisation a VFD device will be placed in the breathing system (Figure 2). The device will be left in situ until manual ventilation ceases during the IHCA event. The VFD will be used with the screen deactivated so as not to affect the airways rescuers normal practice. Cessation of manual ventilation may occur for the following reasons: patient resumed breathing spontaneously, use of mechanical ventilator, decision to stop resuscitation event (death). Anonymised ventilation data will be downloaded following each IHCA event. The following data will be collected alongside from the existing NCAA data and AIRWAYS-3 CRF. * Age * Actual Weight (kg) - Measured or estimated * Height (cm) * Gender (M/F) * Calculated Ideal Body Weight (kg) * Duration of arrest * Presenting rhythm * Outcome of arrest - dead/alive * Recorded respiratory disease * Timeline of airway insertion events * Advanced airway arm Respiratory data to be collected from VFD: * Duration of intervention * Average TV (ml) * Largest TV (ml) * Smallest TV (ml) * Average (mean) leak volume (ml) * Average respiratory rate * Average (mean) inspiratory time (s) * Average (mean) expiratory time (s) Mean and range values will be recorded for each parameter and grouped according to advanced airway device used. Data will be analysed using a commercial statistical software package. Descriptive and comparative statistical calculations will be performed including mean/median average, standard deviation, correlation, the Chi Square and Student t tests. Correlations and predictions will include regression analysis, Wilcoxon Rank Sum and ANOVA. If more advanced statistical analysis is required (the need for which will be based on the results from the simple statistical calculations and quality of data obtained), then a formal statistical consult will be sought from the Warwick Clinical Trials Unit. Sample Size A power calculation has been completed. Experimental bench data suggests manual bag ventilation achieved tidal volumes of 480ml during cardiopulmonary resuscitation. Based on a mean tidal volume of 500ml to detect a minimal difference of 100ml with a standard deviation of 100ml with power set at 80% and significance of 0.05. The study will require 15 participants per group. Total sample size = 30.

Cardiac Arrest

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓As per AIRWAYS-3 trial:
  • ✓Undergoing resuscitation and requiring advanced airway management in the opinion of the trained clinician...

Who cannot take part

  • ✗As per AIRWAYS-3 trial
  • ✗Patients who have a heart arrest outside hospital and who are transported to the hospital in ongoing heart 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
See the full criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Where Is This Study? (1 UK site)

Royal United Hospital Bath

Bath BA13NG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Amy Lloyd

ruh-tr.researchgovernance@nhs.net01225 821669

How to Get in Touch

James Penketh

Sponsor contact

CONTACT

07973504245 jpenketh@nhs.net

Jerry Nolan

Sponsor contact

CONTACT

jerry.nolan@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2025-07