Clinical trial NCT05380687: Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training
Official title: Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Weaning
Respiration, Artificial
Respiratory Muscles
Respiratory Failure
Critical Care
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2022-05-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover of 2 trainings (A and B)
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* pregnancy
* refusal of participation
* pre-existing neuromuscular disorders (e.g., Guillain-Barré)

Primary outcomes:
measure: 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
timeFrame: Measured each 3 mintues during blocks A1 and B1: initial 30 minutes of training in both trainings A and B (cumulative: 2x 30 minutes)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: Measured each 3 mintues during block A3: third next 30 minutes of training in training A (cumulative: 1x 30 minutes)
measure: 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
timeFrame: Measured each 3 mintues during block B3: third next 30 minutes of training in training B (cumulative: 1x 30 minutes)
measure: 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
timeFrame: 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)
Secondary outcomes:
measure: Change in RSBI (ml*min)
timeFrame: Measured at each breath during 30 minutes in block B3 (at zero PEEP; cumulative 30 minutes)
measure: Change in P0.1 (cmH2O)
timeFrame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in Cdyn (ml / cmH2O)
timeFrame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in Raw (cmH2O * L / s)
timeFrame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in PIP (cmH2O)
timeFrame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in DTF
timeFrame: Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in ICTF
timeFrame: Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in IOTF
timeFrame: Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in MIP (cmH2O)
timeFrame: Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
measure: Change in MEP (cmH2O)
timeFrame: Measured during an inspiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
measure: Change in ∆Pocc (cmH2O)
timeFrame: Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
measure: Change in NVE (ml/µv)
timeFrame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in TV (ml)
timeFrame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in ∆Edi (µV)
timeFrame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in Pplat (cmH2O)
timeFrame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
measure: Change in static PEEP (cmH2O)
timeFrame: Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: Head of the department of critical care medicine, Antwerp University Hospital
name: Philippe G Jorens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: