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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05380687
Other study ID # 002418
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2022
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source University Hospital, Antwerp
Contact Petra Vertongen
Phone 3 821 4404
Email icu-research@uza.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 31, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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)

Study Design


Intervention

Diagnostic Test:
Inspiratory hold
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 hold
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 muscles
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.
Other:
PEEP 10
Positive End-Expiratory Pressure of 10cmH2O for 30 minutes
PEEP 5
Positive End-Expiratory Pressure of 5cmH2O for 30 minutes
PEEP 0
Positive End-Expiratory Pressure of 0cmH2O for 30 minutes

Locations

Country Name City State
Belgium Antwerp University Hospital Edegem Antwerp

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Antwerp Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 each 3 mintues during blocks A1 and B1: initial 30 minutes of training in both trainings A and B (cumulative: 2x 30 minutes)
Primary 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 each 3 mintues during blocks A2 and B2: second next 30 minutes of training in both trainings A and B (cumulative: 2x 30 minutes)
Primary 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 each 3 mintues during block A3: third next 30 minutes of training in training A (cumulative: 1x 30 minutes)
Primary 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 each 3 mintues during block B3: third next 30 minutes of training in training B (cumulative: 1x 30 minutes)
Primary 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 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 Change in RSBI (ml*min) Rapid shallow breathing index, calculated as tidal volume divided by respiratory rate Measured at each breath during 30 minutes in block B3 (at zero PEEP; cumulative 30 minutes)
Secondary Change in P0.1 (cmH2O) Airway pressure at the first 100 milliseconds of a breath Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary Change in Cdyn (ml / cmH2O) Dynamic respiratory system compliance, calculated as tidal volume divided by driving pressure Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary Change in Raw (cmH2O * L / s) Respiratory system resistance, calculated as (peak inspiratory pressure - plateau pressure) / flow Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary Change in PIP (cmH2O) Peak Inspiratory Pressure Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary 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 for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary 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 for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary 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 for 5 breaths in the 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary Change in MIP (cmH2O) Maximal inspiratory pressure Measured during an expiratory hold of = 30 seconds between each training block (AH0-4 & BH0-4; cumulative = 5 minutes)
Secondary Change in MEP (cmH2O) Maximal expiratory pressure Measured during an inspiratory hold of = 30 seconds between each training block (AH0-4 & BH0-4; cumulative = 5 minutes)
Secondary Change in ?Pocc (cmH2O) Airway occlusion pressure Measured during an expiratory hold of = 30 seconds between each training block (AH0-4 & BH0-4; cumulative = 5 minutes)
Secondary 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 at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary Change in TV (ml) Tidal volume Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary Change in ?Edi (µV) Increase in electrical activity of the diaphragm (Edi) during inspiration, calculated as Edi high - Edi low. Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary Change in Pplat (cmH2O) Airway plateau pressure Measured at each breath during 30 minutes for each training block (A1-4 & B1-4; cumulative 4hours)
Secondary Change in static PEEP (cmH2O) Postive end-expiratory pressure as measured during an expiratory hold. Measured during an expiratory hold of = 30 seconds between each training block (AH0-4 & BH0-4; cumulative = 5 minutes)
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