Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Neuroventilatory efficiency (NVE) during a zero-assist breath in neural pressure support mode with a pressure support level of 7cmH2O and a PEEP of 10 cmH2O
研究概览
简要总结
The TONES trial aims to evaluate the neuroventilatory efficiency (NVE = tidal volume / peak voltage of diaphragm contraction) measured during a zero-assist manoeuvre (ZAM, i.e. with PEEP but without pressure support). This novel parameter, NVE-ZAM, will be studied in a blocked, crossover, repeated measures design.
Possible confounders, such as activity of respiratory muscles other than the diaphragm, are included.
The investigators hypothesized that
- the NVE during a zero-assist maneuver has a low variability and high repeatability at the same level of PEEP (within subjects, within blocks)
- NVE-ZAM trends differ between participants (between subjects, within blocks) and between PEEP levels (within subjects, between blocks)
The primary aim is to study the variability and repeatability of the NVE-ZAM within subjects and within blocks.
Additionally, the effect of PEEP, muscle fatigue and recruitment of the accessory and expiratory muscles of respiration on the NVE-ZAM will be studied in an exploratory analysis (in multiple combinations of within and between subjects and/or blocks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (18-80 yrs.)
- •admitted to the ICU
- •intubated and mechanically ventilated
- •Edi catheter (Maquet, Solna, Sweden) in situ as part of their clinical care
- •ventilated in a support mode (e.g. pressure support) with a support between 7 and 15 cmH2O, a PEEP ≤10 cmH2O and an Fi02 <0.6, all since ≥6 hours.
- •can participate in the trial as judged by their attending physician
排除标准
- •pregnancy
- •refusal of participation
- •pre-existing neuromuscular disorders (e.g., Guillain-Barré)
研究组 & 干预措施
Training A - PEEP 10-5-5-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training A, the 4 blocks are
A1. PEEP 10 cmH2O | A2. PEEP 5 cmH2O | A3. PEEP *5* cmH2O | A4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: Inspiratory hold (Diagnostic Test)
Training A - PEEP 10-5-5-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training A, the 4 blocks are
A1. PEEP 10 cmH2O | A2. PEEP 5 cmH2O | A3. PEEP *5* cmH2O | A4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: Expiratory hold (Diagnostic Test)
Training A - PEEP 10-5-5-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training A, the 4 blocks are
A1. PEEP 10 cmH2O | A2. PEEP 5 cmH2O | A3. PEEP *5* cmH2O | A4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: Ultrasound of respiratory muscles (Diagnostic Test)
Training A - PEEP 10-5-5-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training A, the 4 blocks are
A1. PEEP 10 cmH2O | A2. PEEP 5 cmH2O | A3. PEEP *5* cmH2O | A4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: PEEP 10 (Other)
Training A - PEEP 10-5-5-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training A, the 4 blocks are
A1. PEEP 10 cmH2O | A2. PEEP 5 cmH2O | A3. PEEP *5* cmH2O | A4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: PEEP 5 (Other)
Training B - PEEP 10-5-0-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training B, the 4 blocks are
B1. PEEP 10 cmH2O | B2. PEEP 5 cmH2O | B3. PEEP *0* cmH2O | B4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: PEEP 0 (Other)
Training B - PEEP 10-5-0-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training B, the 4 blocks are
B1. PEEP 10 cmH2O | B2. PEEP 5 cmH2O | B3. PEEP *0* cmH2O | B4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: Inspiratory hold (Diagnostic Test)
Training B - PEEP 10-5-0-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training B, the 4 blocks are
B1. PEEP 10 cmH2O | B2. PEEP 5 cmH2O | B3. PEEP *0* cmH2O | B4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: Expiratory hold (Diagnostic Test)
Training B - PEEP 10-5-0-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training B, the 4 blocks are
B1. PEEP 10 cmH2O | B2. PEEP 5 cmH2O | B3. PEEP *0* cmH2O | B4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: Ultrasound of respiratory muscles (Diagnostic Test)
Training B - PEEP 10-5-0-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training B, the 4 blocks are
B1. PEEP 10 cmH2O | B2. PEEP 5 cmH2O | B3. PEEP *0* cmH2O | B4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: PEEP 10 (Other)
Training B - PEEP 10-5-0-5
The respiratory muscles of all participants will be trained in 4 consecutive blocks of 30 minutes during ventilation in neural pressure support mode (NPS) with a pressure support of 7 cmH2O.
During training B, the 4 blocks are
B1. PEEP 10 cmH2O | B2. PEEP 5 cmH2O | B3. PEEP *0* cmH2O | B4. PEEP 5 cmH2O
During the training, ventilator data will be recorded and respiratory muscles will be imaged using ultrasound.
Before and after each training block, an inspiratory and an expiratory hold (both ≤ 30 seconds) will be performed to assess fatigue.
干预措施: PEEP 5 (Other)
结局指标
主要结局
Neuroventilatory efficiency (NVE) during a zero-assist breath in neural pressure support mode with a pressure support level of 7cmH2O and a PEEP of 10 cmH2O
时间窗: Measured each 3 mintues during blocks A1 and B1: initial 30 minutes of training in both trainings A and B (cumulative: 2x 30 minutes)
Measured using an Edi catheter (Maquet, Solna, Sweden) each 3 minutes as tidal volume / delta Edi. Zero assist is defined as a pressure support of 0 cmH2O during a single breath.
Neuroventilatory efficiency (NVE) during a zero-assist breath in neural pressure support mode with a pressure support level of 7cmH2O and a PEEP of 0 cmH2O
时间窗: Measured each 3 mintues during block B3: third next 30 minutes of training in training B (cumulative: 1x 30 minutes)
Measured using an Edi catheter (Maquet, Solna, Sweden) each 3 minutes as tidal volume / delta Edi. Zero assist is defined as a pressure support of 0 cmH2O during a single breath.
Neuroventilatory efficiency (NVE) during a zero-assist breath in neural pressure support mode with a pressure support level of 7cmH2O and a PEEP of 5 cmH2O
时间窗: Measured each 3 mintues during blocks A4 and B4: fourth next 30 minutes of training in both trainings A and B (cumulative: 2x 30 minutes)
Measured using an Edi catheter (Maquet, Solna, Sweden) each 3 minutes as tidal volume / delta Edi. Zero assist is defined as a pressure support of 0 cmH2O during a single breath.
Neuroventilatory efficiency (NVE) during a zero-assist breath in neural pressure support mode with a pressure support level of 7cmH2O and a PEEP of 5 cmH2O
时间窗: Measured each 3 mintues during blocks A2 and B2: second next 30 minutes of training in both trainings A and B (cumulative: 2x 30 minutes)
Measured using an Edi catheter (Maquet, Solna, Sweden) each 3 minutes as tidal volume / delta Edi. Zero assist is defined as a pressure support of 0 cmH2O during a single breath.
Neuroventilatory efficiency (NVE) during a zero-assist breath in neural pressure support mode with a pressure support level of 7cmH2O and a PEEP of 5 cmH2O
时间窗: Measured each 3 mintues during block A3: third next 30 minutes of training in training A (cumulative: 1x 30 minutes)
Measured using an Edi catheter (Maquet, Solna, Sweden) each 3 minutes as tidal volume / delta Edi. Zero assist is defined as a pressure support of 0 cmH2O during a single breath.
次要结局
- Change in ∆Edi (µV)(Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in MEP (cmH2O)(Measured during an inspiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes))
- Change in NVE (ml/µv)(Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in ICTF(Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in RSBI (ml*min)(Measured at each breath during 30 minutes in block B3 (at zero PEEP; cumulative 30 minutes))
- Change in P0.1 (cmH2O)(Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in IOTF(Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in ∆Pocc (cmH2O)(Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes))
- Change in static PEEP (cmH2O)(Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes))
- Change in Cdyn (ml / cmH2O)(Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in PIP (cmH2O)(Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in MIP (cmH2O)(Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes))
- Change in Pplat (cmH2O)(Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in Raw (cmH2O * L / s)(Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in DTF(Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))
- Change in TV (ml)(Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours))