Respiratory Parameters Using Advanced Airways During In-hospital Cardiac Arrest

Royal United Hospitals Bath NHS Foundation Trust

Status

Enrolling

Conditions

Cardiac Arrest

Study type

Observational

Funder types

Other

Identifiers

NCT06580652

328233

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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