Cardiac arrest Cardiac arrest
Conditions
Interventions
Participating ambulance services will use pre-assembled CPR kits, containing a bag-valve-mask system with either a PEEP valve or a sham valve. These kits will be 1:1 randomized, with the PEEP valve de
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patients with out-of-hospital cardiac arrest who receive an advanced airway
Exclusion criteria
Exclusion criteria: Any potential subject who meets the following criteria will be excluded from the study:Suspected traumatic cardiac arrestSuspected cardiac arrest after drowningAirway management and ventilation initiated with a non-study resuscitator by a provider from a non-participating ambulance serviceContinuous use of mechanical ventilationTraumatic OHCA (e.g. due to blunt or penetrating trauma) and cardiac arrest following drowning will be excluded due to their distinct pathophysiology. In contrast, arrests resulting from hanging, strangulation, or foreign body airway obstruction will be included. The trial will not exclude females of childbearing age or those with known or suspected pregnancy. Short-term mechanical ventilation used to facilitate patient transport (e.g., during fire department hoisting) will be allowed, provided it is not initiated directly after airway management and used only during transport, without being continued beyond the immediate transport period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is neurological outcome at hospital discharge, assessed by the utility-weighted modified Rankin Scale within the principal stratum estimand. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are of an exploratory nature and should be interpreted as preliminary findings. They aim to generate hypotheses for future studies rather than provide definitive conclusions.Safety parametersTo evaluate the effect of the intervention on the occurrence of clinically significant pneumothorax, defined as the need for drainage through (needle) thoracostomy or chest tube.To evaluate the effect of the intervention on successful ventricular fibrillation termination, defined as the presence of a non-shockable rhythm 5 seconds after the shock. Physiological parametersTo evaluate the effect of the intervention on airway opening index, a measure of intra-arrest intrathoracic airway closure.To evaluate whether the intervention affects thoracic impedance, reflecting changes in lung inflation during CPR.To evaluate the effect of the intervention on the intra-arrest blood gas parameters (pO2, pCO2, pH, base excess, bicarbonate, lactate) drawn in the hospital.To evaluate the effect of the intervention on atelectasis, defined as the fractional area of atelectasis on standardized CT scan if made as part of routine post-resuscitation care. Clinical outcomesTo evaluate the effect of the intervention on 30-day survival.To evaluate the effect of the intervention on dichotomized neurological favorable survival, as indicated by a score of 3 or less on the mRS.To evaluate the effect of the intervention on health-related quality of life among survivors at 6 months after cardiac arrest, measured through the EQ-5D-5L questionnaire. | — |
Countries
Netherlands
Contacts
Public ContactJ.A. Eijk
Amsterdam UMC
Outcome results
None listed