Does Tracheal Suction During Extubation in Intensive Care Unit Decrease Functional Residual Capacity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ΔEELI 15
研究概览
简要总结
Little is known about the procedure of extubation of patients admitted in Intensive Care Units (ICU). In particular, effects of tracheal suction during extubation have never been evaluated. Tracheal suction induces alveolar derecruitment in sedated patients under mechanical ventilation and is a major source of pain.
The aim of this study was to evaluate the impact of tracheal suction during the extubation procedure of critically ill patients on the end-expiratory lung volume.
详细描述
This is a prospective, monocentric study, conducted in the surgical ICU of the university hospital of Rouen, France.
Sixty patients were expected to be randomized before extubation into two groups (ratio of 1:1) with different extubation protocols depending on whether tracheal suction was performed or not.
After oral information and collection of the non opposition of the patient to participate in the study, eligible patients were randomized (raio 1:1) in two groups: "tracheal suction" group or "no tracheal suction" group.
The allocation concealment was assured by enclosing assignments in sequentially numbered, opaque, sealed envelopes. Envelopes were opened after enrolment of each patient by the medical doctor in charged. Each envelope contained a number by a random allocation process using a computer-generated random block design (the randomization list was established by the local biostatistics unit before the beginning of the study).
Juste after inclusion, the 30 minutes standardized extubation protocol started and consisted of:
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age of 18 years or more
- •hospitalization in the surgical ICU (whatever the cause of hospitalization)
- •under mechanical ventilation via a tracheal tube (oro or nasotracheal) for at least 24 hours
- •satisfying general criteria for mechanical ventilation weaning (described by the French Language Resuscitation Society)
- •having successfully completed a spontaneous breathing trial (among those described by the SRLF)
- •physiotherapist available during the first hour after extubation
排除标准
- •the presence of an electrical implantable medical device (pacemaker, automatic defibrillator, deep brain stimulation box)
- •body mass index (BMI) > 50
- •pregnancy
- •tracheal tube with subglottic suction channel
- •technical impossibility of monitoring by electrical impedance tomography (chest plaster, undrained pneumothorax, ...).
研究组 & 干预措施
no tracheal suction
After a standardized protocol during the thirty minutes before extubation, extubation was performed without tracheal suction.
干预措施: no tracheal suction (Procedure)
tracheal suction
After a standardized protocol during the thirty minutes before extubation, extubation was performed with a standardized tracheal suction.
干预措施: tracheal suction (Procedure)
结局指标
主要结局
ΔEELI 15
时间窗: 15 minutes after extubation
The primary endpoint was the end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 15 minutes after extubation (ΔEELI 15). It happened so 45 minutes after inclusion (30 minutes of extubation protocol and 15 minutes after extubation)
次要结局
- Lowest oxygen saturation by pulse oximetry(360 minutes after extubation)
- Oxygen flow(360 minutes after extubation)
- ΔEELI H1(60 minutes after extubation)
- ΔEELI H2(120 minutes after extubation)
- arterial partial pressure of oxygen(360 minutes after extubation)
- arterial oxygen saturation(360 minutes after extubation)
- arterial partial pressure of carbon dioxide(360 minutes after extubation)
- Respiratory rates(360 minutes after extubation)
- Respiratory complication(48 hours after extubation)
- Death(48 hours after extubation)