An Early Phase 1 interventional study of Handivent Ventilator in Cardiac Arrest and Hyperventilation, sponsored by University of Utah. Completed. Per ClinicalTrials.gov, last updated 2016-08-10.
Sponsored by University of Utah · Early Phase 1, Interventional, and Treatment
The objective of this study is to determine whether healthcare professionals trained in CPR can deliver more effective ventilations during CPR using the Handivent, a novel turbine-driven ventilator as compared to bag-valve-mask ventilations, using a manikin model. The investigators believe the Handivent will deliver a more accurate respiratory rate and tidal volume, with lower intrathoracic pressure during CPR.
Previous studies have shown that increased respiratory rate during CPR inversely correlates with blood pressure. Higher respiratory rates increase intrathoracic pressure, which in turn decreases venous return to the heart.
In one previous study, the authors looked at 3 groups of 7 pigs, ventilated at 12 (100% O2), 30 (100%), and 30 (5% CO2, 95% 02) breaths per minute during cardiac arrest, and showed increased mortality with increasing respiratory rate. Survival rates were 6/7, 1/7, and 1/7 respectively. The results of this study led to changing the CPR guidelines in 2005 to include fewer ventilations.
The authors also observed 13 cases of CPR in the field and noted EMS personnel delivered breaths at an average of 32 bpm.
In 2012, a similar study to the current study under proposal compared a pressure-limited, pneumatically driven ventilator to bag-valve-mask in simulated CPR, using medical student volunteers. That study did not show a significant difference in tidal volumes; however, they did not record respiratory rates or mean intrathoracic pressures. Furthermore, that ventilator was pneumatically -driven and pressure limited, whereas the ventilator we propose to study is turbine-driven and can be volume/time triggered.
926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.
This study's enrollment of 24 is below the median of 100 across 518 interventional studies indexed under Heart Arrest.
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Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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Exclusion Criteria:
CPR simulation with and without ventilator
Device: Handivent Ventilator
CPR with use of a turbine-driven ventilator (Handivent)
Respiratory rate
The study will measure the respiratory rate delivered during the 8-minute CPR scenario
Time frame: RR will be the average RR during the CPR simulation, which is 8-minutes in duration.
Tidal volume
The study will measure the tidal volume delivered during the 8-minute CPR scenario
Time frame: Average Vt during CPR simulation, which is 8 minutes in duration
Peak Inspiratory pressure
the study will measure the peak inspiratory pressure delivered during the 8-minute CPR scenario
Time frame: Average PIP delivered during CPR simulation, which is 8 minutes in duration.
No study locations are listed for this record.
Plan to share: No
The record gives a start of Apr 2013, a primary completion of Jun 2013 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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