Renovate Palliative Study: Randomized Controlled Trial Comparing High Flow Nasal Catheter Versus Standard Respiratory Support in Patients With Do Not Intubate Order and Acute Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Dypnea
研究概览
简要总结
Randomized clinical trial in which the main objective is to compare High Flow Nasal Cannula (HFNC) versus the standard respiratory care in the alleviation of dyspnea perception in patients with do-not-intubate (DNI) order. This is a pragmatic study that will take place in 10 Brazilians ICU facilities which are already participating in the main study RENOVATE NCT03643939.
详细描述
Do-not-intubate (DNI) is usually established in cases where endotracheal intubation (ETI) is considered disproportionate to prognosis and/or incompatible with the expression of wishes and values of the patient. Regardless of the profile of this care plan offered to patients with DNI, the control of dyspnea is one of its central objectives. The approach to dyspnea includes pharmacological measures such as opioids and non-pharmacological measures, such as oxygen therapy and Non-Invasive Ventilation, and more recently, the high flow nasal catheter (HFNC). HFNC provides high flow of heated and humidified mixed gas through a nasal cannula. In addition to the ability to generate high flows and supplemental oxygen, HFNC may generate a low level of positive airway pressure, may decrease dead space ventilation and may contribute to better patient comfort, such as the possibility of oral feeding while undergoing treatment, performing oral hygiene and allowing conversation and interaction with family members. This pilot study aims to evaluate the efficacy of HFNC in reducing dyspnea and improving comfort in patients with Acute Respiratory Failure (ARF) and DNI order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will have no access to randomisation list and won't be able to guess which group participant was allocated to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 18 years of age or older, with ARF of any cause on admission or post-extubation with prior DNI directives or DNI order determined in the current hospitalization.
- •Patients must meet the following criteria below:
- •Dyspnea (defined on the Borg scale ≥4);
- •SpO2 <90% or paO2 <60 mmHg in room air;
- •Absence of delirium;
- •One of the following:
- •A. Signs of respiratory distress and use of accessory muscles; B. Respiratory rate greater than 25 incursions per min .
排除标准
- •Refusal of treatment;
- •Agitation or non-cooperation;
- •Presence of delirium at the time of randomization;
- •Anatomical abnormalities that may interfere with the adjustment of the non-invasive positive pressure ventilation mask
- •Glasgow <12;
- •Psychomotor agitation that prevents adequate medical / nursing assistance requiring sedation;
- •Contraindications to NIV: uncontrollable vomiting, hypersecretion of the airways, facial deformities, trauma or extensive facial burn;
- •Presence of pneumothorax or extensive pleural effusion;
- •Expected imminent death, defined as an estimated death of less than 24 hours.
结局指标
主要结局
Dypnea
时间窗: 48 hours
Variation in dyspnea according to the Borg scale in 48 hours.
次要结局
- Dose of Opioid(48 hours)
- Delirium(48 hours)
- Intensive Care Unit (ICU) stay(28 days)
- Mortality(28 days)
- Comfort(48 hours)
- Usage of respiratory support devices(48 hours)