NCT05843123已完成4 期
Comparison of Carbon Dioxide Control During Pressure Controlled (PC) Versus Pressure Regulated Volume Control (PRVC) Ventilation in Children (CoCO2): a Digital, Randomized Controlled Trial
University Children's Hospital, Zurich2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2024年1月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Adherence to the allocated ventilation mode among randomized/enrolled participants
研究概览
简要总结
This study assesses the feasibility of digital data collection for a randomized controlled trial in a quaternary pediatric intensive care unit and the effect of two commonly used mechanical ventilation modes on gas exchange (CO2) in children over 2 days after randomization.
This is a single-center, open-labelled, randomized controlled trial with two parallel 1:1 treatment arms: pressure controlled (PC) vs pressure-regulated volume controlled (PRVC) mechanical ventilation modes.
Use to routine digital data is essential to enable health learning systems and to provide rapid clinical trials readiness, as the pandemic has demonstrated. Despite availability of data to perform digital trials in PICU settings, these are yet scarcely done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent provided by the participant or the participant's parents or legal guardians. In case of an emergency situation, a physician who is independent of the research project must be consulted prior to inclusion in order to safeguard the interests of the test subject.
- •Admission to PICU at the University Children's Hospital Zurich
- •Need for mechanical ventilation for >60 min during PICU hospitalization. Need for mechanical ventilation will be based on clinical decision of the treating physician.
- •Need for an arterial line during PICU hospitalization. Need for an arterial line will be based on clinical decision of the treating physician.
- •Age <18 years
- •Weight >2 Kg
排除标准
- •Substantial air leaks around the endotracheal tube (>30%)
- •Cyanotic shunt lesions
- •Intracranial hypertension (i.e. traumatic brain injury or patients admitted after neurosurgery)
- •Pulmonary hypertension under treatment (i.e sildenafil or inhaled nitric oxide)
- •Time from start of invasive mechanical ventilation until time of screening is > 24 hours
- •Previous enrolment in the study in the past 30 days
- •Inability of the parents or legal guardians to understand the study due to linguistic or cognitive reasons
结局指标
主要结局
Adherence to the allocated ventilation mode among randomized/enrolled participants
时间窗: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
Main feasibility outcome
Proportion of time spent within the target range of carbon dioxide (normocarbia, defined as carbon dioxide ≥ 35 mmHg or 4.5 kPa and ≤ 45 mmHg or 6 kPa) measured using end-tidal carbon dioxide recorded every minute by the ventilation device
时间窗: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
Main physiological outcome
次要结局
- Number of patients who were screened, were missed, gave consent and were randomized/enrolled per month(From date of recruitment start until date of recruitment end (assessed when n=60, anticipated through 6 months of recruitment period))
- Proportion of enrolled participants with complete primary and secondary outcome data extracted from the electronic patient records(From date of recruitment start until date of study end (assessed when n=60 and data has been extracted for all participants, anticipated through 8 months))
- Reasons for protocol violations(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours since randomization))
- Time from randomization to protocol violation(From time of randomization until time of protocol violation (assessed up to 48 hours))
- Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours))
- Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours))
- Time from ventilation start until screening(From time of ventilation start until time of screening (assessed up to 48 hours))
- Time from ventilation start until randomization(From time of ventilation start until time of randomization (assessed up to 48 hours))
- Time from consent until randomization(From time of consent signed until time of randomization (assessed up to 48 hours))
- Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa), measured using continuous end-tidal carbon dioxide(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours))
- Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using intermittent arterial blood measurements(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours))
- Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours))
- Time weighted average of hypo- and hypercarbia (i.e. outside normocarbia, carbon dioxide < 35 mmHg or 4.5 kPa; or carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours))
- Time weighted average of hypercarbia (carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours))
- Time weighted average of hypo- and hypercarbia (i.e. outside normocarbia, carbon dioxide < 35 mmHg or 4.5 kPa; or carbon dioxide >45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours))
- Time weighted average of hypo- and hypercarbia (i.e. carbon dioxide < 35 mmHg or 4.5 kPa; or >45 mmHg or 6 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis(From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours))
研究者
研究点 (2)
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