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临床试验/NCT06716463
NCT06716463
招募中
不适用

PREdicting Failure of Non-inVasIve Ventilatory Support Using Non-invaSIve mONitoring in Non-intubated Patients With Acute Hypoxemic Respiratory Failure or Post-extubation Failure: the PREVISION Study

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 80 人2025年1月27日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Ventilatory Failure
发起方
Unity Health Toronto
入组人数
80
试验地点
1
主要终点
Difference in regional ventilation distribution (%)
状态
招募中
最后更新
11个月前

概览

简要总结

The goal of this observational study is to assess the potential non-invasive tools (e.g. regional ventilation, respiratory muscle response, lung mechanic's parameters) to identify the risk of failure when using high flow nasal cannula (HFNC) or non-invasive ventilation (NIV).

The main question, it aims to answer is:

Does abnormal regional ventilation could predict HFNC or NIV failure?

详细描述

This is a single-center, prospective, physiological study. The study will enroll patient who has used either HFNC or NIV for the indications of 1. to prevent worsening acute hypoxemic respiratory failure or 2. to prevent reintubation. Once being confirmed to meet the inclusion criteria, the research team will apply the electrical impedance tomography (EIT) on the patient and start recording for 5-10 minutes as well as perform diaphragm and parasternal intercostal muscle ultrasound when the patient is using HFNC or NIV. The current HFNC or NIV setting, some lung mechanic's parameters (e.g. rapid shallow breathing trial (RSBI), negative airway pressure generated during the first 100 milisecond (P0.1), end-expiratory occlusion pressure(ΔPocc) derived from NIV machine), patient's characteristic, dyspnea scores (intensive care respiratory distress observation scale, IC-RDOS; work of breathing scale; self-report of dyspnea visual analog scale, D-VAS), ICU and hospital length of stay will be also collected. The investigator will use EIT to visualize where air goes in the patient's lung and inspiratory muscle ultrasonography (diaphragm and parasternal intercostal muscle) to visualize the muscle activities when using HFNC or NIV. EIT is a measurement often used in the ICU since it allows easy visualization and is a non-invasive technique. The sensors measure electrical current changes during inspiration and expiration and will not cause any pain or radiation concerns. The EIT belt (3-cm diameter) will be placed around the chest without causing adverse event/discomfort/pain. The duration of study will be approximately 30 minutes. The study will be conducted one time for one enrolled patient. HFNC or NIV (device) failure is considered as either intubation/reintubation or death, whatever has come first. It will be followed up to 7 days. The investigators will proceed with the measurements only with agreement from the clinical team. The investigators will analyze the data collected offline with a dedicated software afterwards. After these study procedures are completed, data will also be collected from the participant's chart and combined with relevant information from the HFNC or NIV settings and vital functions. Confidentiality will be maintained throughout the entire study.

注册库
clinicaltrials.gov
开始日期
2025年1月27日
结束日期
2025年6月
最后更新
11个月前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Age of ≥ 18 years
  • Using NIV or HFNC anywhere in the hospital

排除标准

  • Chronic CO2 retention
  • Neuromuscular disorder
  • Requiring home NIV (CPAP or BIPAP)
  • Tracheostomy
  • Contraindication to EIT placement: pacemaker/defibrillator implantation, burns at the area of EIT placement

结局指标

主要结局

Difference in regional ventilation distribution (%)

时间窗: The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.

The primary endpoint is to assess regional ventilation distribution (%) when using HFNC or NIV to predict a device failure.

次要结局

  • Diaphragm or parasternal intercostal muscle thickening fraction(The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.)
  • Rapid shallow breathing index (RSBI) in mL/breaths/min(The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.)
  • Respiratory drive using negative airway pressure generated during the first 100 millisecond (P0.1)(The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.)
  • Respiratory effort using end-expiratory airway occlusion pressure (ΔPocc)(The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.)
  • The intensive care respiratory distress observation scale (IC-RDOS)(The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.)
  • The work of breathing scale(The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.)
  • Self-report of dyspnea visual analog scale (D-VAS)(The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.)

研究点 (1)

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