Ventilator WeaningTONESNCT05380687
Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training
A study testing Inspiratory hold, Expiratory hold and Ultrasound of respiratory muscles in people with Ventilator Weaning and Respiration, Artificial, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator Weaning, Respiration, Artificial, Respiratory Muscles
- What is being tested?
- Inspiratory hold, Expiratory hold and Ultrasound of respiratory muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- refusal of participation
- pre-existing neuromuscular disorders (e.g., Guillain-Barré)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Conditions
- Ventilator Weaning, Respiration, Artificial, Respiratory Muscles, Respiratory Failure, Critical Care
- Being tested
- Inspiratory hold, Expiratory hold, Ultrasound of respiratory muscles, PEEP 10, PEEP 5
- Medical subject headings
- Respiratory Aspiration, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory holdDiagnostic test
A short period (< 30 seconds) during which both inspiratory and expiratory valves of the ventilator circuit are closed at the end of inspiration. It is used to asses expiratory force generation (maximal expiratory pressure, MEP) and frequently used in clinical practice.
Expiratory holdDiagnostic test
A short period (< 30 seconds) during which both inspiratory and expiratory valves of the ventilator circuit are closed at the end of expiration. It is used to asses static PEEP and inspiratory force generation (maximal inspiratory pressure, MIP \& occlusion pressure, ∆Pocc) and is frequently used in clinical practice.
Ultrasound of respiratory musclesDiagnostic test
Ultrasound of the diaphragm, parasternal intercostal muscle and internal oblique muscle will be performed during each block. Thickening fractions, calculated as thickness at end-inspiration minus thickness at end-expiration divided by thickness at end-expiration, are used to assess the contribution of the muscle to the tidal volume. A median over 5 breaths will be calculated.
PEEP 10Other
Positive End-Expiratory Pressure of 10cmH2O for 30 minutes
PEEP 5Other
Positive End-Expiratory Pressure of 5cmH2O for 30 minutes
PEEP 0Other
Positive End-Expiratory Pressure of 0cmH2O for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Training A - PEEP 10-5-5-5 | Experimental | 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. Receives: Diagnostic Test: Inspiratory hold; Diagnostic Test: Expiratory hold; Diagnostic Test: Ultrasound of respiratory muscles; Other: PEEP 10; Other: PEEP 5 |
| Training B - PEEP 10-5-0-5 | Experimental | 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. Receives: Diagnostic Test: Inspiratory hold; Diagnostic Test: Expiratory hold; Diagnostic Test: Ultrasound of respiratory muscles; Other: PEEP 10; Other: PEEP 5; Other: PEEP 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Measured each 3 mintues during blocks A1 and B1: initial 30 minutes of training in both trainings A and B (cumulative: 2x 30 minutes)
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
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.
Measured: 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)
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
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.
Measured: Measured each 3 mintues during block A3: third next 30 minutes of training in training A (cumulative: 1x 30 minutes)
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
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.
Measured: Measured each 3 mintues during block B3: third next 30 minutes of training in training B (cumulative: 1x 30 minutes)
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
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.
Measured: 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 (16)
Change in RSBI (ml*min)
Rapid shallow breathing index, calculated as tidal volume divided by respiratory rate
Measured: Measured at each breath during 30 minutes in block B3 (at zero PEEP; cumulative 30 minutes)
Change in P0.1 (cmH2O)
Airway pressure at the first 100 milliseconds of a breath
Measured: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in Cdyn (ml / cmH2O)
Dynamic respiratory system compliance, calculated as tidal volume divided by driving pressure
Measured: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in Raw (cmH2O * L / s)
Respiratory system resistance, calculated as (peak inspiratory pressure - plateau pressure) / flow
Measured: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in PIP (cmH2O)
Peak Inspiratory Pressure
Measured: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in DTF
Diaphragm thickening fraction, calculated as (diaphragm thickness at end-inspiration - diaphragm thickness at end-expiration) / diaphragm thickness at end-expiration [dimensionless]. Muscle thickness will be measured in millimeters using M-mode ultrasound with the probe placed perpendicular to the muscle (not including the thickness of fascial muscle layers).
Measured: Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in ICTF
Parasternal intercostal muscle thickening fraction, calculated as (parasternal intercostal muscle thickness at end-inspiration - parasternal intercostal muscle thickness at end-expiration) / parasternal intercostal muscle thickness at end-expiration [dimensionless]. Muscle thickness will be measured in millimeters using M-mode ultrasound with the probe placed perpendicular to the muscle (not including the thickness of fascial muscle layers).
Measured: Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in IOTF
Internal oblique muscle thickening fraction, calculated as (internal oblique muscle thickness at end-inspiration - internal oblique muscle thickness at end-expiration) / internal oblique muscle thickness at end-expiration [dimensionless]. Muscle thickness will be measured in millimeters using M-mode ultrasound with the probe placed perpendicular to the muscle (not including the thickness of fascial muscle layers).
Measured: Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in MIP (cmH2O)
Maximal inspiratory pressure
Measured: Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
Change in MEP (cmH2O)
Maximal expiratory pressure
Measured: Measured during an inspiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
Change in ∆Pocc (cmH2O)
Airway occlusion pressure
Measured: Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
Change in NVE (ml/µv)
Neuroventilatory efficiency, calculated as tidal volume divided by delta Edi. It is measured at a pressure support of 7 cmH2O, i.e. NOT during a zero assist manoeuvre.
Measured: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in TV (ml)
Tidal volume
Measured: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in ∆Edi (µV)
Increase in electrical activity of the diaphragm (Edi) during inspiration, calculated as Edi high - Edi low.
Measured: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in Pplat (cmH2O)
Airway plateau pressure
Measured: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in static PEEP (cmH2O)
Postive end-expiratory pressure as measured during an expiratory hold.
Measured: Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start15 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover of 2 trainings (A and B)
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Philippe G Jorens, MD, PhD, Principal investigator, Head of the department of critical care medicine, Antwerp University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380687
- Sponsor's protocol ID
- 002418
- Acronym
- TONES
- Status last verified
- Jun 2023
- First submitted
- 9 May 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Time series of NVE-ZAM will be plotted per participant and reported in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training
- ClinicalTrials.gov ID
- NCT05380687
- Acronym / sponsor ID
- TONES / 002418
- Conditions
- Ventilator Weaning, Respiration, Artificial, Respiratory Muscles, Respiratory Failure, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover of 2 trainings (A and B)
| Arm | Type | Receives |
|---|---|---|
| Training A - PEEP 10-5-5-5 | Experimental | Diagnostic Test: Inspiratory hold, Diagnostic Test: Expiratory hold, Diagnostic Test: Ultrasound of respiratory muscles, Other: PEEP 10, Other: PEEP 5The 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. |
| Training B - PEEP 10-5-0-5 | Experimental | Diagnostic Test: Inspiratory hold, Diagnostic Test: Expiratory hold, Diagnostic Test: Ultrasound of respiratory muscles, Other: PEEP 10, Other: PEEP 5, Other: PEEP 0The 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- pregnancy
- refusal of participation
- pre-existing neuromuscular disorders (e.g., Guillain-Barré)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory holdA short period (< 30 seconds) during which both inspiratory and expiratory valves of the ventilator circuit are closed at the end of inspiration. It is used to asses expiratory force generation (maximal expiratory pressure, MEP) and frequently used in clinical practice. | Diagnostic test | Training A - PEEP 10-5-5-5, Training B - PEEP 10-5-0-5 |
| Expiratory holdA short period (< 30 seconds) during which both inspiratory and expiratory valves of the ventilator circuit are closed at the end of expiration. It is used to asses static PEEP and inspiratory force generation (maximal inspiratory pressure, MIP \& occlusion pressure, ∆Pocc) and is frequently used in clinical practice. | Diagnostic test | Training A - PEEP 10-5-5-5, Training B - PEEP 10-5-0-5 |
| Ultrasound of respiratory musclesUltrasound of the diaphragm, parasternal intercostal muscle and internal oblique muscle will be performed during each block. Thickening fractions, calculated as thickness at end-inspiration minus thickness at end-expiration divided by thickness at end-expiration, are used to assess the contribution of the muscle to the tidal volume. A median over 5 breaths will be calculated. | Diagnostic test | Training A - PEEP 10-5-5-5, Training B - PEEP 10-5-0-5 |
| PEEP 10Positive End-Expiratory Pressure of 10cmH2O for 30 minutes | Other | Training A - PEEP 10-5-5-5, Training B - PEEP 10-5-0-5 |
| PEEP 5Positive End-Expiratory Pressure of 5cmH2O for 30 minutes | Other | Training A - PEEP 10-5-5-5, Training B - PEEP 10-5-0-5 |
| PEEP 0Positive End-Expiratory Pressure of 0cmH2O for 30 minutes | Other | Training B - PEEP 10-5-0-5 |
Primary outcome
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
Time frame: 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 5 cmH2O
Time frame: 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
Time frame: 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.
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
Time frame: 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
Time frame: 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.
16 secondary outcomes
Change in RSBI (ml*min)
Time frame: Measured at each breath during 30 minutes in block B3 (at zero PEEP; cumulative 30 minutes)
Change in P0.1 (cmH2O)
Time frame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in Cdyn (ml / cmH2O)
Time frame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in Raw (cmH2O * L / s)
Time frame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in PIP (cmH2O)
Time frame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in DTF
Time frame: Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in ICTF
Time frame: Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in IOTF
Time frame: Measured for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in MIP (cmH2O)
Time frame: Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
Change in MEP (cmH2O)
Time frame: Measured during an inspiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
Change in ∆Pocc (cmH2O)
Time frame: Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
Change in NVE (ml/µv)
Time frame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in TV (ml)
Time frame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in ∆Edi (µV)
Time frame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in Pplat (cmH2O)
Time frame: Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Change in static PEEP (cmH2O)
Time frame: Measured during an expiratory hold of ≤ 30 seconds between each training block (AH0-4 & BH0-4; cumulative ≤ 5 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Yes. Time series of NVE-ZAM will be plotted per participant and reported in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe G Jorens, MD, PhD principal investigator
Head of the department of critical care medicine, Antwerp University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory hold, Expiratory hold and Ultrasound of respiratory muscles in people with Ventilator Weaning and Respiration, Artificial, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Measured each 3 mintues during blocks A1 and B1: initial 30 minutes of training in both trainings A and B (cumulative: 2x 30 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.