Loading clinical trials...
Loading clinical trials...
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).
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Antwerp University Hospital
Edegem, Antwerp, Belgium
Start Date
June 15, 2022
Primary Completion Date
December 31, 2023
Completion Date
December 31, 2023
Last Updated
April 4, 2025
1
ACTUAL participants
Inspiratory hold
DIAGNOSTIC_TEST
Expiratory hold
DIAGNOSTIC_TEST
Ultrasound of respiratory muscles
DIAGNOSTIC_TEST
PEEP 10
OTHER
PEEP 5
OTHER
PEEP 0
OTHER
Lead Sponsor
University Hospital, Antwerp
Collaborators
NCT07098611
NCT04080440
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions