错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

A comparative study of targeted end-tidal carbon dioxide versus standard management to guide resuscitation in emergency department cardiac arrest in Thailand: study protocol for a three-arm randomised controlled trial

  • Winchana Srivilaithon,
  • Chitlada Limjindaporn,
  • Kumpol Kornthatchapong,
  • Intanon Imsuwan,
  • Kiattichai Daorattanachai,
  • Nipon Diskumpon,
  • Ittabud Dasanadeba,
  • Yaowapha Siripakarn,
  • Thosapol Ueamsaranworakul,
  • Chatchanan Pornpanit,
  • Nat Chatchairatanavej,
  • Piyawat Tivirach

摘要

Background

Cardiac arrest managed in the emergency department (ED) is associated with suboptimal survival outcomes. End-tidal carbon dioxide (EtCO2) monitoring during cardiopulmonary resuscitation (CPR) reflects cardiac output, tissue perfusion, and pulmonary blood flow. Observational evidence suggests that higher EtCO2 levels during CPR are associated with return of spontaneous circulation (ROSC), but the effect of actively targeting higher EtCO2 thresholds remains uncertain. The primary objective of this trial is to determine whether CPR guided by higher EtCO2 targets improves sustained ROSC compared with a standard EtCO2 target among patients with ED cardiac arrest.

Methods

This is a single-centre, three-arm, single-blind, superiority randomised controlled trial conducted in the ED of Thammasat University Hospital, Pathum Thani, Thailand. Eligible participants are patients with ED cardiac arrest, including out-of-hospital cardiac arrest patients receiving CPR in the ED and patients with first in-hospital cardiac arrest occurring in the ED. Exclusion criteria include age < 15 years, traumatic cardiac arrest, a do-not-attempt-resuscitation order, and signs of irreversible death. Post-randomisation exclusions include inability to obtain EtCO2 monitoring through an advanced airway and ROSC before the first EtCO2 measurement. Consecutive eligible participants will be screened and enrolled by the attending emergency physician. Participants will be randomised in a 1:1:1 ratio using fixed-block randomisation with a block size of six; no stratification variables will be used. The planned sample size is 300 participants, with 100 participants per group. All participants will receive high-quality CPR according to international resuscitation guidelines and will be assigned to one of three EtCO2 targets: ≥ 10 mmHg, ≥ 20 mmHg, or ≥ 25% of venous partial pressure of carbon dioxide (PvCO2), with a minimum threshold of 10 mmHg. Peripheral venous PvCO2 will be obtained using point-of-care testing every 10 min. Chest compression depth and rate will be titrated in 0.5-cm and 10/min increments, respectively, every 30 s until the assigned EtCO2 target is achieved. The primary outcome is sustained ROSC. Secondary outcomes include survival to hospital discharge and survival with favourable neurological outcome. Safety and harm measures include adverse events related to the study intervention, unanticipated device-related issues, and complications attributed to study-directed chest-compression adjustments. These events will be documented, reported to the coordinating centre and ethics committee as required, and reviewed by the Data Safety Monitoring Board. Analyses will follow both intention-to-treat and per-protocol principles.

Discussion

This trial will evaluate whether higher absolute or patient-specific EtCO2 targets during CPR improve resuscitation outcomes compared with the standard EtCO2 threshold in ED cardiac arrest patients.

Trial registration

Thai Clinical Trials Registry (TCTR), TCTR20240619001, registered on 19 June 2024: https://www.thaiclinicaltrials.org/show/TCTR20240619001.