Respiratory Parameters Using Advanced Airways During In-hospital Cardiac Arrest

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: James Penketh; Phone Number: 07973504245; Email: jpenketh@nhs.net
• Study Contact Backup: Name: Jerry Nolan; Email: jerry.nolan@nhs.net

Study Locations

• United Kingdom
  • Banes
    • Bath, Banes, United Kingdom, BA13NG
      • Recruiting
      • Royal United Hospital Bath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean leak	The mean volume of leak recorded 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.
inspiratory time	The mean inspiratory time 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.
Expiratory time	The mean expiratory time 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate	Mean Respiratory rate delivered 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.
Smallest tidal volume	The smallest tidal volume delivered 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.
largest tidal volume	The largest tidal volume delivered 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.
duration of intervention	The time for which the airway device was used 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.

Collaborators and Investigators

• Sponsor: Royal United Hospitals Bath NHS Foundation Trust
• Collaborators: RCUK
• Investigators: Study Chair: Kelly Spencer, Royal United Hosptial Bath

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest
• Other Study ID Numbers: 328233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No