Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?

Обзор

To give chest compressions during cardiopulmonary resuscitation (CPR), mechanical chest compression devices can be used. During synchronous 30:2 CPR, the standard setting on these devices leave an automated 3-second chest compression pause after 30 compressions to facilitate caregivers in providing two ventilations. With this standard setting, research has shown that in less than half of ventilation pauses during CPR, those two ventilations are given. Increasing the ventilation pause duration to 5 seconds instead of 3 seconds is also an option following current guideline recommendations, and aligns with measured ventilation pause duration in manual CPR. Increasing pause duration to 5 seconds could result in an increased ventilation success rate. This multicenter randomized controlled trial will randomize LUCAS® mechanical compression devices to a standard setting of 3- or 5-second compression pauses. The main outcome will be the percentage of ventilation pauses in which two ventilations are successfully given. Secondary outcomes include the restoration of spontaneous circulation (ROSC), and the difference in (neurologically intact) survival. No study has been performed to evaluate this effect yet.

Вмешательства

• Другое 5-second ventilation pause duration during mechanical CPR
  The intervention is a 5-second lasting ventilation pause during mechanical CPR
• Другое 3-second ventilation pause duration during mechanical CPR
  The intervention is a 3-second lasting ventilation pause during mechanical CPR

Первичные конечные точки

• Percentage of ventilation pauses in which two ventilations are given [Срок оценки: From enrollment to end of mechanically assisted CPR by ambulance nurses (approximate maximum timeframe of 3 hours)]

Вторичные конечные точки (12)

• Return of spontaneous circulation (ROSC) [Срок оценки: From enrollment to end of cardiac arrest treatment (approximate maximum timeframe of 5 hours)]
• Cerebral performance score (CPC score) at hospital discharge (CPC 1-2 vs. 3-4) [Срок оценки: From enrollment to hospital discharge (approximate maximum timeframe of 3 months)]
• Survival to hospital discharge [Срок оценки: From enrollment to hospital discharge (approximate maximum timeframe of 3 months)]
• 30-day survival [Срок оценки: From enrollment to 30 days after cardiac arrest]
• Number of rhythm checks per five minutes, expected [Срок оценки: From enrollment to prehospital termination of CPR or handover at hospital by ambulance nurses (approximate maximum timeframe of 3 hours)]
• Number of rhythm checks per five minutes, observed [Срок оценки: From enrollment to prehospital termination of CPR or handover at hospital by ambulance nurses (approximate maximum of 3 hours)]
• Average tidal volume (ml) [Срок оценки: From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours)]
• Average minute volume (ml/min) [Срок оценки: From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours)]
• Average respiratory rate (rate per minute) [Срок оценки: From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours)]
• Average airway pressure (cmH2O) [Срок оценки: From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours)]
• Chest compression fraction (CCF) [Срок оценки: From enrollment to end of intra-arrest registration of ambulance monitor (approximate maximum timeframe of 3 hours)]
• Subjective experience of ambulance nurses with the mechanical CPR device and it's ventilation pause settings [Срок оценки: After the last inclusion of the study, with an approximate time frame of 1-2 months to respond to the anonymous survey]

Критерии участия

Критерии включения

• Adults (≥16 years of age)
• OHCA patients with an attempt at cardiopulmonary resuscitation (CPR) by ambulance personnel
• LUCAS® 3.1 has been used during the resuscitation attempt

Критерии исключения

• Missing ambulance run report, missing or unclear impedance signal (measurement of resistance across the thorax), making it impossible to assess the number of ventilation pauses
• Absence of a minimum of 3 assessable pauses intended for ventilation after connecting the LUCAS®

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 2 центра

• Ambulance Amsterdam — Amsterdam
• Regionale Ambulance Voorziening Kennemerland - Ambulancezorg GGD Kennemerland — Haarlem

Идентификаторы

NCT: NCT06824961 · LUCASVP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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