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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (1 UK site)
Royal United Hospital Bath
Bath BA13NG, United Kingdom
How to Get in Touch
James Penketh
Sponsor contactCONTACT
Jerry Nolan
Sponsor contactCONTACT
