Respiratory Failure Clinical Trial
— TONESOfficial title:
Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training
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 |
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).
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) |
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | Research Foundation Flanders |
Belgium,
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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