Mechanical Ventilation ComplicationTWEEPNCT03856424
Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients
A study testing Modality 1, Modality 2 and Modality 3 in people with Mechanical Ventilation Complication, run by Piquilloud Imboden Lise at 1 site in Switzerland.
Trial summary
Datas are lacking concerning weaning from mechanical ventilation for tracheostomized patients. In particular, the effect of different modalities of spontaneous breathing trials on respiratory effort has not been extensively described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Modality 1, Modality 2 and Modality 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Mar 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for whom a tracheostomy is planned
- Patients on invasive ventilation for >72 hours
Who cannot join
- Tracheostomy for upper airway obstruction or other disease
- Patients tracheostomized before current hospitalization
- Patients with Glasgow Coma Scale (GCS) < 8/10 after cardiac arrest
- Patients with GCS < 8/10 because of primary central neurologic disease
- Patients for whom therapeutic limitations have already been decided
- Patients for whom weaning from ventilation is not an objective
Show all 10Show fewer
- Patients suffering from myasthenia gravis
- Patients with cardiac assistance device
- Patients with medullary lesion proximal to C5
- Patients for whom nasogastric tube insertion is contraindicated
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospitals
Lausanne, Canton of Vaud, 1011
Lise Piquilloud Imboden, PD&MER, +41 79 556 68 27, lise.piquilloud@chuv.ch
About this study
Official title: Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients. Monocentric Crossover Interventionnal Study.
Datas are lacking concerning weaning from mechanical ventilation for tracheostomized patients. In particular, the effect of different modalities of spontaneous breathing trials on respiratory effort has not been extensively described.
This crossover physiology study will include 18 tracheostomized patients ventilated for more than 72 hours.
The objective of this study is to compare the effect of three different modalities of SBTs on respiratory effort in tracheostomized patients. The modalities tested are : Pressure Support Ventilation (PSV level 5 cmH2O, PEEP 5 cmH2O), T-piece test and high-flow Oxygen. Each modality is applied in a randomized order, during 30 minutes. During every modality tested, esophageal and gastric pressure, expired CO2, and comfort will be monitored, in addition to standard monitoring. Based on esophageal pressure monitoring, patient's respiratory efforts can be calculated either by esophageal pressure-time product and work of breathing. Pressure generated by inspiratory muscles will also be assessed.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Modality 1, Modality 2, Modality 3
- Keywords
- Ventilation, Tracheotomy, Difficult weaning, Spontaneous Breathing Test, Esophageal pressure, Work of breathing, Esophageal pressure time-product, Difficult weaning from mechanical ventilation, Ventilation weaning
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modality 1Procedure or surgery
Pressure support ventilation (PSV) modality
Modality 2Procedure or surgery
T-Piece modality
Modality 3Procedure or surgery
High-flow oxygen
| Study group | Role | What they receive |
|---|---|---|
| Modality 1 - Washout - Modality 2 - Washout - Modality 3 | Other | Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. Receives: Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3 |
| Modality 1 - Washout - Modality 3 - Washout - Modality 2 | Other | Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. Receives: Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3 |
| Modality 2 - Washout - Modality 1 - Washout - Modality 3 | Other | Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. Receives: Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3 |
| Modality 2 - Washout - Modality 3 - Washout - Modality 1 | Other | Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. Receives: Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3 |
| Modality 3 - Washout - Modality 2 - Washout - Modality 1 | Other | Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. Receives: Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3 |
| Modality 3 - Washout - Modality 1 - Washout - Modality 2 | Other | Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. Receives: Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of pressure-time product of esophageal pressure
Quantification of inspiratory effort of the patient
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Secondary outcomes (27)
Evolution of work of breathing (WOB)
Total area of a Campbell diagram for esophageal pressure and volume during one respiratory cycle
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of esophageal pressure drop
Maximum variation of esophageal pressure during respiratory cycles
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of inspiratory muscle pressure (Pmus)
Pressure generated by patients' respiratory muscles
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of transdiaphragmatic pressure (Ptransdiaph)
Difference between gastric and esophageal pressure. Reflect of pressure generated by diaphragm during inspiration
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of tidal volume (VT)
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of respiratory rate (RR)
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of inspiratory airway flow
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of ratio of inspiratory time over total duration of a breathing cycle (ti/ttot)
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of Rapid Shallow Breathing Index (RSBI)
RR/VT - predictor during ventilation weaning of intolerance of SBT
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of respiratory system compliance (Crs)
Capacity of total respiratory system to gain volume for a given pressure
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of lungs compliance (CL)
Capacity of lungs to gain volume for a given pressure
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of chest wall compliance (Ccw)
Capacity of lungs to gain volume for a given pressure
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of transpulmonary pressure (Ptranspulm)
Alveolar pressure minus pleural pressure
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of ratio of total dead space volume over tidal volume
Calculated by means of expired CO2 and arterial blood gas CO2
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of total dead space volume
Calculated by means of expired CO2
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of total Positive End-Expiratory Pressure (PEEPtot)
Airway pressure during end-expiratory ventilator occlusion
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of heart rate
Standard monitoring
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of blood pressure
Standard monitoring
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of Plateau pressure (Pplat)
Airway pressure during end-inspiratory ventilator occlusion (corresponds to alveolar pressure)
Measured: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of intrinsic Positive End-Expiratory Pressure (PEEPi)
PEEPi minus PEEP set on ventilator
Measured: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Pulmonary strain
Measured as the ratio of tidal volume over functionnal residual capacity (FRV)
Measured: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of Diaphragmatic excursion (DE)
Ultrasound measurement of diaphragm movement during inspiration
Measured: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Diaphragmatic thickening fraction (DTF)
Ultrasound measurement of diaphragm thickening during inspiration
Measured: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of hematocrits
Mesured by arterial blood
Measured: Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Richmond Agitation/Sedation scale (RASS) score
Used in ICU to monitor neurologic changes in patients. Scale from -5 (unarousable) to +4 (combative). 0 is a calm and responsive patient.
Measured: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Borg dyspnea scale score
Numeric scale to quantify dyspnea from 0 to 10. 0 mean patient does not feel that breathing is difficult and 10 is a maximal dyspnea.
Measured twice during each Spontaneous Breathing Trial
Measured: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Multidimensionnal dyspnea scale (MDP) score
Score to quantify comfort, dyspnea and assess respiratory effort as perceived by patient. This scale contains multiple items, divided in two dimensions : sensory and affective.
Sensory dimension contains : intensity on a scale of 0 to 10 of five sensory qualities (physical breathing effort, air hunger, tightness, mental breathing effort, hyperpnoea) Affective dimension contains : a breathing discomfort scale (scale of 0 to 10)
Measured once during each Spontaneous Breathing Trial
Measured: Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start8 Mar 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three different spontaneous breathing trials modalities will be tested in each patient in a randomized order. Washout periods will be performed between the tested modalities.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piquilloud Imboden Lise
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Piquilloud Imboden Lise, University of Lausanne Hospitals
- Investigators
- Lise Piquilloud Imboden, MER&PD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856424
- Sponsor's protocol ID
- TWEEP
- Acronym
- TWEEP
- Status last verified
- May 2022
- First submitted
- 28 Jan 2019
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients. Monocentric Crossover Interventionnal Study.
- ClinicalTrials.gov ID
- NCT03856424
- Acronym / sponsor ID
- TWEEP / TWEEP
- Conditions
- Mechanical Ventilation Complication
- Keywords
- Ventilation, Tracheotomy, Difficult weaning, Spontaneous Breathing Test, Esophageal pressure, Work of breathing, Esophageal pressure time-product, Difficult weaning from mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Piquilloud Imboden LiseUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Datas are lacking concerning weaning from mechanical ventilation for tracheostomized patients. In particular, the effect of different modalities of spontaneous breathing trials on respiratory effort has not been extensively described.
This crossover physiology study will include 18 tracheostomized patients ventilated for more than 72 hours.
The objective of this study is to compare the effect of three different modalities of SBTs on respiratory effort in tracheostomized patients. The modalities tested are : Pressure Support Ventilation (PSV level 5 cmH2O, PEEP 5 cmH2O), T-piece test and high-flow Oxygen. Each modality is applied in a randomized order, during 30 minutes. During every modality tested, esophageal and gastric pressure, expired CO2, and comfort will be monitored, in addition to standard monitoring. Based on esophageal pressure monitoring, patient's respiratory efforts can be calculated either by esophageal pressure-time product and work of breathing. Pressure generated by inspiratory muscles will also be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Three different spontaneous breathing trials modalities will be tested in each patient in a randomized order. Washout periods will be performed between the tested modalities.
| Arm | Type | Receives |
|---|---|---|
| Modality 1 - Washout - Modality 2 - Washout - Modality 3 | Other | Procedure: Modality 1, Procedure: Modality 2, Procedure: Modality 3Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. |
| Modality 1 - Washout - Modality 3 - Washout - Modality 2 | Other | Procedure: Modality 1, Procedure: Modality 2, Procedure: Modality 3Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. |
| Modality 2 - Washout - Modality 1 - Washout - Modality 3 | Other | Procedure: Modality 1, Procedure: Modality 2, Procedure: Modality 3Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. |
| Modality 2 - Washout - Modality 3 - Washout - Modality 1 | Other | Procedure: Modality 1, Procedure: Modality 2, Procedure: Modality 3Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. |
| Modality 3 - Washout - Modality 2 - Washout - Modality 1 | Other | Procedure: Modality 1, Procedure: Modality 2, Procedure: Modality 3Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. |
| Modality 3 - Washout - Modality 1 - Washout - Modality 2 | Other | Procedure: Modality 1, Procedure: Modality 2, Procedure: Modality 3Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients for whom a tracheostomy is planned
- Patients on invasive ventilation for >72 hours
Key exclusion criteria (10 listed)
- Tracheostomy for upper airway obstruction or other disease
- Patients tracheostomized before current hospitalization
- Patients with Glasgow Coma Scale (GCS) < 8/10 after cardiac arrest
- Patients with GCS < 8/10 because of primary central neurologic disease
- Patients for whom therapeutic limitations have already been decided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modality 1Pressure support ventilation (PSV) modality | Procedure or surgery | Modality 1 - Washout - Modality 2 - Washout - Modality 3, Modality 1 - Washout - Modality 3 - Washout - Modality 2, Modality 2 - Washout - Modality 1 - Washout - Modality 3, Modality 2 - Washout - Modality 3 - Washout - Modality 1, Modality 3 - Washout - Modality 1 - Washout - Modality 2, Modality 3 - Washout - Modality 2 - Washout - Modality 1 |
| Modality 2T-Piece modality | Procedure or surgery | Modality 1 - Washout - Modality 2 - Washout - Modality 3, Modality 1 - Washout - Modality 3 - Washout - Modality 2, Modality 2 - Washout - Modality 1 - Washout - Modality 3, Modality 2 - Washout - Modality 3 - Washout - Modality 1, Modality 3 - Washout - Modality 1 - Washout - Modality 2, Modality 3 - Washout - Modality 2 - Washout - Modality 1 |
| Modality 3High-flow oxygen | Procedure or surgery | Modality 1 - Washout - Modality 2 - Washout - Modality 3, Modality 1 - Washout - Modality 3 - Washout - Modality 2, Modality 2 - Washout - Modality 1 - Washout - Modality 3, Modality 2 - Washout - Modality 3 - Washout - Modality 1, Modality 3 - Washout - Modality 1 - Washout - Modality 2, Modality 3 - Washout - Modality 2 - Washout - Modality 1 |
Primary outcome
Evolution of pressure-time product of esophageal pressure
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Quantification of inspiratory effort of the patient
27 secondary outcomes
Evolution of work of breathing (WOB)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of esophageal pressure drop
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of inspiratory muscle pressure (Pmus)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of transdiaphragmatic pressure (Ptransdiaph)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of tidal volume (VT)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of respiratory rate (RR)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of inspiratory airway flow
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of ratio of inspiratory time over total duration of a breathing cycle (ti/ttot)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of Rapid Shallow Breathing Index (RSBI)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of respiratory system compliance (Crs)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of lungs compliance (CL)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of chest wall compliance (Ccw)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of transpulmonary pressure (Ptranspulm)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of ratio of total dead space volume over tidal volume
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of total dead space volume
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of total Positive End-Expiratory Pressure (PEEPtot)
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of heart rate
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of blood pressure
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of Plateau pressure (Pplat)
Time frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of intrinsic Positive End-Expiratory Pressure (PEEPi)
Time frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Pulmonary strain
Time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of Diaphragmatic excursion (DE)
Time frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Diaphragmatic thickening fraction (DTF)
Time frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of hematocrits
Time frame: Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Richmond Agitation/Sedation scale (RASS) score
Time frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Borg dyspnea scale score
Time frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Multidimensionnal dyspnea scale (MDP) score
Time frame: Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Piquilloud Imboden, MER&PD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modality 1, Modality 2 and Modality 3 in people with Mechanical Ventilation Complication, run by Piquilloud Imboden Lise at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Piquilloud Imboden, MER&PD (+41 79 556 68 27, lise.piquilloud@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of pressure-time product of esophageal pressure (time frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.