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NCT05380687: TONES
Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training
NA trial testing Inspiratory hold in Ventilator Weaning in 1 participant. Completed in 31 December 2023.
31 December 2023
Quick facts
| Lead sponsor | University Hospital, Antwerp |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1 |
| Start date | 15 June 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Inspiratory hold
- Expiratory hold
- Ultrasound of respiratory muscles
- PEEP 10
- PEEP 5
- PEEP 0
Conditions studied
- Ventilator Weaning — all drugs for Ventilator Weaning →
- Respiration, Artificial — all drugs for Respiration, Artificial →
- Respiratory Muscles — all drugs for Respiratory Muscles →
- Respiratory Failure — all drugs for Respiratory Failure →
Sponsor
University Hospital, Antwerp
Who can join
Adults 18 to 80, any sex, with Ventilator Weaning or Respiration, Artificial. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05380687
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other University Hospital, Antwerp trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05380687 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Antwerp
- Last refreshed: 4 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05380687.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing