Assessment of Clinical Practice of Mechanical Ventilation After COVID-19 Pan-demic Among 57 Countries: A Systematic Analysis for the Global BurdEn of Me-chanIcal VeNtilatIon (GEMINI Study) 2022, From VENTILAGROUP.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,900
- 试验地点
- 1
- 主要终点
- ICU mortality
研究概览
简要总结
BACKGROUND: Changes in the clinical practice of mechanical ventilation during and after the coronavirus pandemic (COVID-19) worldwide could influence the clinical outcomes of critically ill patients with mechanical ventilation due to a generalization of these changes. Thus, the variability of the clinical response of different strategies in critically ill patients could be related to the existence of unidentified phenotypes that would be related to an increased risk of mortality and functional deterioration at the medium term.
OBJECTIVES: The main objective will be to evaluate the worldwide clinical practice of mechanical Ventilation in critically ill patients, as well as the medium-term clinical outcomes for the description of phenotypes of critically ill patients treated with mechanical ventilation.
The analysis of phenotypes and unsupervised pattern recognition over time could help to predict relevant clinical outcomes. This approach could improve personalized and precision medicine applicable to the ventilated patient. METHODOLOGY: An observational, prospective, non-interventional, international, and multicenter study will be carried out that will include adult critically ill patients requiring invasive or non-invasive mechanical ventilation for more than 12 hours. Analyzes of the variability of mortality and functional impairment at six months will be performed. Likewise, artificial intelligence analyzes ("machine learning" and "neural networks") will be carried out.
详细描述
Patient Population and Participating Centers Research personnel prospectively will follow up all newly admitted adult patients admitted in the ICU who received ventilator support. A region will be defined as a country or collection of countries represented by a National Coordinator. We aimed to include a total amount of ICUs with similar characteristics (approximately 1525 ICUs) from each region accordingly to the global population of the participating country. Participating centers Recruitment for participation in GEMINI study will be by open invitation, through the Steering Committee. National Coordinators will be selected, and committed to enroll local ICUs for the inclusion of patients. Participation is entirely voluntary, with no financial incentive.
Institutional review board/ Local Ethics committees approval will be obtained by the participating institutions in accordance with local ethical regulations.Currently, the study has been approved by the Ethics Committee of the Universitary Hospital of Getafe, Madrid, Spain as a coordinating center (CEIM 22/27).
Study design This will be an observational, prospective, no interventional, international and multicenter study coordinated by Hospital universitarian from Getafe, Madrid, Spain in 52 countries (see appendix for participanting regions) and will have a inclusion period of 3 months recruitment window, and then to pick any consecutive 4 week period within that window.
The recruitment framing will start October 1st 2022 until march 31th 2023. Then, a follow-up period at six months after hospital discharge.
The project will be inscribed in a Web-based resource that will provide patients, their family members, health care professionals, researchers, and the public an easy access to information regarding the protocol (clinicaltrials.gov) before the starting of the study. Study outcomes, data collection, and statistical analyses will be established a priori and submitted for publication in a peer-review International Journal before data access.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 119 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive adult patients (≥ 18 years old) who are admitted to the ICU and require invasive mechanical ventilation (endotracheal tube or tracheostomy) longer than 12 hours.
- •Adult patients admitted to the ICU and require advanced respiratory support (high flow oxygen nasal cannula [HFONC], or noninvasive ventilation [NIV] BIPAP or CPAP with oronasal, nasal, helmet or facial mask) with acute respiratory failure defined as PaO2/ fraction of inspired oxygen (FiO2), [PaO2/FiO2] ratio <300, or the pulse oximetric saturation (SpO2/FiO2 ) ratio < 315 for more than 1 hour.
- •Adult patients in whom mechanical ventilation were started outside the study ICU at the same Institution and/or a different Institution, including Emergency Room, Operating Room (OR), /or were then transferred to the ICU at the participating center
排除标准
- •The following ICUs will be excluded:
- •Pediatric ICU.
- •Post-Operators Anesthesia Recovery Room.
- •Patients less than 18 years old.
- •Patients admitted after elective surgery and who require mechanical ventilation for less than 12 hours (excepting patients who receive non-invasive ventilation).
- •Patients will be excluded if they were transferred to participating ICUs without a documented intubation time, or underwent a tracheotomy at prior to ICU admission.
- •Patients that were at participating ICUs for 24 hours or more, were readmitted during the study period
结局指标
主要结局
ICU mortality
时间窗: From date of inclusion until the date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks
rate of dead patients requiring mechanical ventilation during ICU stay
次要结局
- duration of mechanical ventilation.(from orotracheal intubation date until scheduled extubation date or 24 hours of unassisted respiratory support in tracheotomized patietns)
- hospital mortality.(From date of inclusion until the date of death from any cause during hospital stay, whichever came first, assessed up to 6 months)
- ventilator-free days (VFD).(events during ICU stay (from ICU admission to ICU discharge dates) From date of orotracheal intubation until the date of unassisted positive pressure ventilation, either without orotracheal tube or tracheal cannula, assessed up to 6 months)
- 28-day mortality.(from initiacion from mechanical ventilation until 28-day hospital stay.)
- 6-months frailty.(from hospital discharge date until 6 months of follow-up in surviors from ICU stay, assessed by Clinical Frailty Scale (CFS, where values between 1-9 points, a higher scores mean a worse outcome))
- ICU stay.(From date of inclusion (ICU admission) until the date of ICU discharge, assessed up to 6 weeks, including survivors and nonsurvivors from ICU)
- decision for withdrawal or withholding vital support rate.(events during ICU admission through study completion, an average of 6 months.)
- 6 months mortality(from hospital discharge date until 6 months of follow-up in surviors from ICU stay.)
- reintubation.(From date of orotracheal scheduled extubation until the date of reintubation from any cause during ICU stay, assessed up to 48 hours)
- hospital stay.(From date of inclusion (ICU admission) until the date of hospital discharge, assessed up to 6 monthss including survivors and nonsurvivors from ICU)
- ICU free days.(events during ICU stay (from ICU admission to ICU discharge dates))
- tracheotomy rate.(events during ICU stay (rate of performance for scheduled tracheotomy, assessed up to 6 months))
研究者
Oscar Penuelas, MD
Principal Investigator. Clinical Chief Intensive Care Unit
Hospital Universitario Getafe