Ventilator WeaningI-DISCONCT03486249
Interaction Diaphragm and Cardiac Function During Ventilator Weaning
A study testing Repetition of medical examinations performed as part of the care in people with Ventilator Weaning, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Weaning failure is associated with prolonged duration of mechanical ventilation that itself can worsen patient's prognosis. Therefore, identification of the causes and mechanisms leading to weaning failure is important in daily practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- Repetition of medical examinations performed as part of the care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2018to 19 Jul 2019
- 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 adult (age ≥ 18 years)
- Intubation and invasive mechanical ventilation longer than 48 hours;
- Failure to the first spontaneous breathing trial;
- Presence of weaning readiness criteria
- Oral informed consent
- Patient with affiliation to the french healthcare system
Who cannot join
- Pregnant women
- Patient opposition
- Contraindication to perform magnetic phrenic nerves stimulation technique (chest tube, cardiac pacemaker or implanted defibrillator, cervical implants, chest drains,...)
- Impossibility to consider ventilator weaning (total ventilator dependence : preexisting neuromuscular disorders, cervical spine injury…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interaction Between Diaphragm and Cardiac Function During Weaning From Mechanical Ventilation
Weaning failure is associated with prolonged duration of mechanical ventilation that itself can worsen patient's prognosis. Therefore, identification of the causes and mechanisms leading to weaning failure is important in daily practice. While diaphragm dysfunction and pulmonary edema are two main causes of weaning failure, there are currently no data that quantify their respective contribution neither their potential co-existence. During weaning from mechanical ventilation, heart and lung interaction plays a major role. As a key factor, diaphragm function is therefore certainly involved in the occurrence of weaning-induced pulmonary edema. However, both phenomenons diaphragm dysfunction and weaning induced pulmonary edema have not been simultaneously investigated so far. This current project aims at exploring the relationship between diaphragm dysfunction and pulmonary in patients experiencing weaning failure. The objectives are 1) to quantify the respective contribution and co-existence of diaphragm dysfunction and weaning induced pulmonary edema and 2) to investigate the role of diaphragm function in the occurrence of weaning induced pulmonary edema.
Read the detailed description
The study will take place in the Medical ICU of Pitié-Salpêtrière Hospital in Paris. The ICU have an established and successful clinical research program and infrastructure.
ICU patients will be enrolled if eligible (based on inclusion and non inclusion criteria) after their first spontaneous breathing trial failure.
Diaphragm function will be assessed by its capacity to generate a pressure with the phrenic nerves stimulation technique (reference method) and by ultrasonography (thickening fraction). Weaning induced pulmonary edema will be diagnosed with cardiac echo and markers of plasma contraction (plasma protein concentration).
Phrenic nerves stimulation, diaphragm and cardiac ultrasound will be repeated as part of the research before the spontaneous breathing trial.
After obtaining consent and before starting the second spontaneous breathing trial, clinical and biological will be collected. EKG and maximal inspiratory pressure will be done. Then, a diaphragm ultrasound and cardiac echo will be done and the phrenic nerves stimulation method will be undertaken. After these measurements, the spontaneous breathing trial will start. At the end of the spontaneous breathing trial (30 minutes with pressure support 7 cmH2O and 0 positive end expiratory pressure) or sooner in case of intolerance (respiratory distress), a new cardiac echo and diaphragm ultrasound will be performed as part of standard care before resuming the initial ventilator settings. As recommended by the usual medical practice, a second phrenic nerves stimulation will be eventually done after resuming the initial ventilator settings.
Diaphragm capacity to generate pressure :
Twitch airway pressure (Ptr, stim) will be measured during phrenic nerve stimulation. Phrenic nerve stimulation will be performed by bilateral anterior magnetic stimulation.
Cardiac echo :
Cardiac echo will be performed with a Philips Sparq ultrasound with a dedicated probe. The following variables will be obtained: left ventricular ejection fraction, E wave, A wave, E' wave, TAPSE
Diaphragm ultrasound :
Diaphragm thickening fraction will be measured by placing 13 MHz transducer on the right chest wall in the ninth intercostal space mid-way between the anterior and mid-axillary line and held perpendicular to the chest wall. Thickening fraction will be computed as the percentage change in thickness between end-expiration (i.e. minimum muscle thickness) and peak inspiration (i.e. maximal muscle thickness) visualized in M-mode.
- Conditions
- Ventilator Weaning
- Being tested
- Repetition of medical examinations performed as part of the care
- Keywords
- diaphragm dysfunction, ventilator weaning, pulmonary edema
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetition of medical examinations performed as part of the careOther
Cardiac echo, diaphragm ultrasound and phrenic nerves stimulation performed before the spontaneous breathing trial.
| Study group | Role | What they receive |
|---|---|---|
| Patient difficult to wean | Experimental | Repetition of medical examinations performed as part of the care. All patients will have a cardiac echo examination and diaphragm function assessment before the spontaneous breathing trial. Receives: Other: Repetition of medical examinations performed as part of the care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure at the spontaneous breathing trial
Weaning failure defined by the criteria of the International Conference on Weaning (Boles et al. ERJ 2007)
Measured: During or at the end of the spontaneous breathing trial
Secondary outcomes (3)
Rate of patients with diaphragm dysfunction
Diaphragm dysfunction will be defined as a decrease capacity of the diaphragm to generate a pressure
Measured: At the end of the patient participation (Day 3)
Rate of patients with weaning induced pulmonary edema
Weaning induced pulmonary edema will be defined by an increase in left filling pressure and/or plasma protides concentration
Measured: At the end of the patient participation (Day 3)
Rate of patients with diaphragm dysfunction and weaning induced pulmonary edema
Diaphragm dysfunction will be defined as a decrease capacity of the diaphragm to generate a pressure and weaning induced pulmonary edema will be defined by an increase in left filling pressure and/or plasma protides concentration
Measured: At the end of the patient participation (Day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start27 Apr 2018
- Primary completion30 Apr 2018
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will have a cardiac echo examination and diaphragm function assessment.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin DRES, MD, PhD, Principal investigator, Assistance Publique Hoptiaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486249
- Sponsor's protocol ID
- K180103J
- Acronym
- I-DISCO
- Status last verified
- Feb 2021
- First submitted
- 27 Mar 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Diaphragm and Cardiac Function During Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03486249
- Acronym / sponsor ID
- I-DISCO / K180103J
- Conditions
- Ventilator Weaning
- Keywords
- diaphragm dysfunction, ventilator weaning, pulmonary edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 3 Apr 2018 (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.
Weaning failure is associated with prolonged duration of mechanical ventilation that itself can worsen patient's prognosis. Therefore, identification of the causes and mechanisms leading to weaning failure is important in daily practice. While diaphragm dysfunction and pulmonary edema are two main causes of weaning failure, there are currently no data that quantify their respective contribution neither their potential co-existence. During weaning from mechanical ventilation, heart and lung interaction plays a major role. As a key factor, diaphragm function is therefore certainly involved in the occurrence of weaning-induced pulmonary edema. However, both phenomenons diaphragm dysfunction and weaning induced pulmonary edema have not been simultaneously investigated so far. This current project aims at exploring the relationship between diaphragm dysfunction and pulmonary in patients experiencing weaning failure. The objectives are 1) to quantify the respective contribution and co-existence of diaphragm dysfunction and weaning induced pulmonary edema and 2) to investigate the role of diaphragm function in the occurrence of weaning induced pulmonary edema.
Detailed description
The study will take place in the Medical ICU of Pitié-Salpêtrière Hospital in Paris. The ICU have an established and successful clinical research program and infrastructure.
ICU patients will be enrolled if eligible (based on inclusion and non inclusion criteria) after their first spontaneous breathing trial failure.
Diaphragm function will be assessed by its capacity to generate a pressure with the phrenic nerves stimulation technique (reference method) and by ultrasonography (thickening fraction). Weaning induced pulmonary edema will be diagnosed with cardiac echo and markers of plasma contraction (plasma protein concentration).
Phrenic nerves stimulation, diaphragm and cardiac ultrasound will be repeated as part of the research before the spontaneous breathing trial.
After obtaining consent and before starting the second spontaneous breathing trial, clinical and biological will be collected. EKG and maximal inspiratory pressure will be done. Then, a diaphragm ultrasound and cardiac echo will be done and the phrenic nerves stimulation method will be undertaken. After these measurements, the spontaneous breathing trial will start. At the end of the spontaneous breathing trial (30 minutes with pressure support 7 cmH2O and 0 positive end expiratory pressure) or sooner in case of intolerance (respiratory distress), a new cardiac echo and diaphragm ultrasound will be performed as part of standard care before resuming the initial ventilator settings. As recommended by the usual medical practice, a second phrenic nerves stimulation will be eventually done after resuming the initial ventilator settings.
Diaphragm capacity to generate pressure :
Twitch airway pressure (Ptr, stim) will be measured during phrenic nerve stimulation. Phrenic nerve stimulation will be performed by bilateral anterior magnetic stimulation.
Cardiac echo :
Cardiac echo will be performed with a Philips Sparq ultrasound with a dedicated probe. The following variables will be obtained: left ventricular ejection fraction, E wave, A wave, E' wave, TAPSE
Diaphragm ultrasound :
Diaphragm thickening fraction will be measured by placing 13 MHz transducer on the right chest wall in the ninth intercostal space mid-way between the anterior and mid-axillary line and held perpendicular to the chest wall. Thickening fraction will be computed as the percentage change in thickness between end-expiration (i.e. minimum muscle thickness) and peak inspiration (i.e. maximal muscle thickness) visualized in M-mode.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will have a cardiac echo examination and diaphragm function assessment.
| Arm | Type | Receives |
|---|---|---|
| Patient difficult to wean | Experimental | Other: Repetition of medical examinations performed as part of the careRepetition of medical examinations performed as part of the care. All patients will have a cardiac echo examination and diaphragm function assessment before the spontaneous breathing trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients adult (age ≥ 18 years)
- Intubation and invasive mechanical ventilation longer than 48 hours;
- Failure to the first spontaneous breathing trial;
- Presence of weaning readiness criteria
- Oral informed consent
Key exclusion criteria (4 listed)
- Pregnant women
- Patient opposition
- Contraindication to perform magnetic phrenic nerves stimulation technique (chest tube, cardiac pacemaker or implanted defibrillator, cervical implants, chest drains,...)
- Impossibility to consider ventilator weaning (total ventilator dependence : preexisting neuromuscular disorders, cervical spine injury…)
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 |
|---|---|---|
| Repetition of medical examinations performed as part of the careCardiac echo, diaphragm ultrasound and phrenic nerves stimulation performed before the spontaneous breathing trial. | Other | Patient difficult to wean |
Primary outcome
Failure at the spontaneous breathing trial
Time frame: During or at the end of the spontaneous breathing trial
Weaning failure defined by the criteria of the International Conference on Weaning (Boles et al. ERJ 2007)
3 secondary outcomes
Rate of patients with diaphragm dysfunction
Time frame: At the end of the patient participation (Day 3)
Rate of patients with weaning induced pulmonary edema
Time frame: At the end of the patient participation (Day 3)
Rate of patients with diaphragm dysfunction and weaning induced pulmonary edema
Time frame: At the end of the patient participation (Day 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
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Recruiting
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
Enrolling by invitation
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
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Not yet recruitingObservational study
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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.
Martin DRES, MD, PhD principal investigator
Assistance Publique Hoptiaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetition of medical examinations performed as part of the care in people with Ventilator Weaning, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 2 Mar 2021. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure at the spontaneous breathing trial (time frame: During or at the end of the spontaneous breathing trial). 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 2 Mar 2021.