Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580652
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-12
Brief Title:
Respiratory Parameters Using Advanced Airways During In-hospital Cardiac Arrest
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measurement of Tidal Volumes Achieved With Tracheal Tubes and Laryngeal Mask Airways During in Hospital Cardiac Arrest
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 MF
Calculated Ideal Body Weight kg
Duration of arrest
Presenting rhythm
Outcome of arrest - deadalive
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 meanmedian 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 005 The study will require 15 participants per group Total sample size 30
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 MF
Calculated Ideal Body Weight kg
Duration of arrest
Presenting rhythm
Outcome of arrest - deadalive
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 meanmedian 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 005 The study will require 15 participants per group Total sample size 30
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None