Cardiac ArrestNCT06580652
Respiratory Parameters Using Advanced Airways During In-hospital Cardiac Arrest
An observational study of Cardiac Arrest, run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Aug 2024to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have suffered a cardiac arrest whilst an in patient.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jerry Nolan contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal United Hospital Bath
Bath, Banes, BA13NG
About this study
Official title: Measurement of Tidal Volumes Achieved With Tracheal Tubes and Laryngeal Mask Airways During in Hospital Cardiac Arrest.
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.
Read the detailed description
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.
- Conditions
- Cardiac Arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Volume
The mean tidal volume achieved during cardiac arrest treatment
Measured: 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
The mean volume of leak recorded during cardiac arrest treatment
Measured: 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
The mean inspiratory time during cardiac arrest treatment
Measured: 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
The mean expiratory time during cardiac arrest treatment
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start28 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- RCUK
- Responsible party
- Sponsor
- Investigators
- Kelly Spencer, Study chair, Royal United Hosptial Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580652
- Sponsor's protocol ID
- 328233
- Status last verified
- Jul 2025
- First submitted
- 12 Mar 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Tidal Volumes Achieved With Tracheal Tubes and Laryngeal Mask Airways During in Hospital Cardiac Arrest.
- ClinicalTrials.gov ID
- NCT06580652
- Acronym / sponsor ID
- 328233
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation TrustUniversity, hospital or other
- Collaborators
- RCUK
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have suffered a cardiac arrest whilst an in patient.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tidal Volume
Time frame: 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.
The mean tidal volume achieved during cardiac arrest treatment
3 secondary outcomes
Mean leak
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jerry Nolan contact
Kelly Spencer study chair
Royal United Hosptial Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Penketh (07973504245, jpenketh@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal Volume (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.