The iso-volume pressure support range: stable tidal volume conceals major physiological changes during pressure support ventilation
| ISRCTN | ISRCTN69141246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69141246 |
| Sponsor | Le Groupe de Recherche Clinique CARMAS |
| Funder | Investigator initiated and funded |
- Submission date
- 26/06/2026
- Registration date
- 30/06/2026
- Last edited
- 30/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Samuel Tuffet
Principal investigator, Public, Scientific
Principal investigator, Public, Scientific
20 quai Claude Bernard
LYON 06
69006
France
| Phone | +33478618210 |
|---|---|
| stuffet@saintjosephsaintluc.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Diagnostic |
| Scientific title | The iso-volume pressure support range: stable tidal volume conceals major physiological changes during pressure support ventilation |
| Study objectives | To characterize the iso-volume pressure support range and evaluate the physiological consequences of pressure support modifications within its boundaries |
| Ethics approval(s) |
Approved 09/07/2018, South West 3 Research Ethics Committee (Comité de protection des personnes Sud Ouest 3) (Groupe hospitalier Pellegrin, Place Amélie Raba Léon, Bordeaux, 33076, France; +33557817607; cpp.soom3@u-bordeaux.fr), ref: 2018-A00867-48 |
| Health condition(s) or problem(s) studied | Patients invasively ventilated in pressure-support mode |
| Intervention | A decremental pressure support titration is performed with steps of 2 cmH₂O, each lasting five minutes, from 20 to 4 cmH₂O. Sedation and analgesia levels are not modified during the titration. PEEP, FiO₂, trigger, pressurization slope, and the expiratory cycling criterion are kept constant as set by the clinician. Titration has to be interrupted in case of arterial hypotension, poor respiratory tolerance (SpO₂ below 88% despite a 20% increase in FiO₂, or respiratory rate above 40 breaths/min for one minute), or at the request of the patient or the physician in charge of the patient. Airway flow is recorded using an AC137A-1 pneumotachograph (Biopac Systems, Goleta, CA, USA) placed between the Y-piece and the endotracheal tube. Airway and esophageal pressures are measured using TSD160D transducers (Biopac Systems). All signals are acquired using AcqKnowledge® software (Biopac Systems, Goleta, CA, USA). EIT monitoring (Enlight 1800, Timpel, São Paulo, Brazil) is performed using a belt positioned around the chest at the fourth to fifth intercostal space. Total duration of the intervention was then 45 minutes for each patient. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 17 |
| Total final enrolment | 17 |
| Key inclusion criteria | 1. Adult (age at least 18 years) 2. Invasively ventilated in pressure support mode |
| Key exclusion criteria | 1. Contra-indication to electrical impedance tomography 2. Pregnancy 3. Legal protection status 4. Refusal of the patient or next of kin |
| Date of first enrolment | 01/09/2018 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- France
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
30/06/2026: Study’s existence confirmed by the South West 3 Research Ethics Committee (Comité de protection des personnes Sud Ouest 3), France.
