Critical IllnessPhase 1PROSENCT03768154
Prone Positioning and Spontaneous Breathing
A Phase 1 study testing Supine + spontaneous effort, Supine + paralysis and Prone + paralysis in people with Critical Illness and ARDS, run by Osaka University at 1 site in Japan.
Trial summary
Spontaneous breathing during mechanical ventilation has been recommended in patients with ARDS and is currently used. in part because oxygenation is better and there is a lower risk of diaphragm dysfunction due to disuse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, ARDS
- What is being tested?
- Supine + spontaneous effort, Supine + paralysis and Prone + paralysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2019to 31 Mar 2021
- Phase
- Phase 1
- 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 ≧ 18 years old
- Patients with moderate-to-severe ARDS as per the Berlin definition
- Patients with esophageal balloon manometry
- Patients planned to turn to prone positioning, based on the attending physician's decisions
Who cannot join
- Contraindication for prone positioning, referring to a previous randomized clinical trial
- Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mmHg
- Massive hemoptysis requiring an immediate surgical or interventional radiology procedure
- Tracheal surgery or sternotomy during the previous 15 days
- Serious facial trauma or facial surgery during the previous 15 days
- Cardiac pacemaker inserted in the last 2 days
Show all 11Show fewer
- Unstable spine, femur, or pelvic fractures
- Major hemodynamic instability:
- Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and two vasopressors or increase of vasopressor dose by 30% in the previous 6 hours.
- Contraindication to EIT electrode placement Burns, chest wall bandaging limiting electrode placement, pacemaker
- Clinical judgement of the attending physician against proning and/or spontaneous breathing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prone Positioning and Spontaneous Breathing: a Feasibility Study
Spontaneous breathing during mechanical ventilation has been recommended in patients with ARDS and is currently used. in part because oxygenation is better and there is a lower risk of diaphragm dysfunction due to disuse. The other approach to minimizing lung injury from spontaneous effort is the use of neuromuscular blockade; an early and short term (48 hours) of neuromuscular blockade in patients with severe ARDS has been shown to decrease inflammation and to improve survival. The investigators propose a pilot study to test the feasibility and the physiological effects of allowing spontaneous breathing in the prone position in patients with ARDS.
Read the detailed description
The multi-center feasibility study will enroll 12 adult ARDS patients from the Intensive Care Units (ICUs) in Japan and Peru. Informed consent will be obtained from the patient or legally authorized substitute decision maker. Moderate-to-severe ARDS patients who are planned to turn to prone positioning, based on the attending physician's decisions will be included. Prior to initiating the protocol, patients will be sedated deeply with sedatives and/or opioids. Ventilator settings, physiological data, esophageal pressure and diaphragm activity will be recorded and physiological measurements will be collected for 5 minutes in supine (Measurement 1: Supine + spontaneous effort) . Patients will be paralyzed with a continuous infusion of rocuronium, and Measurement 2 (Supine + paralysis) will be recorded. The critical care team in the ICU change the position from supine to prone. After waiting for at least 1 hour in prone positioning, Measurement 3 (Prone + paralysis) will be recorded. Continuous infusion of rocuronium will be gradually decreased (and can be terminated) until spontaneous breathing will be observed without reaching an excessive level. The presence of spontaneous breathing will be evaluated by the negative swing of esophageal pressure, and Measurement 5 (Prone + spontaneous breathing) will be recorded.
- Conditions
- Critical Illness, ARDS
- Being tested
- Supine + spontaneous effort, Supine + paralysis, Prone + paralysis, Prone + spontaneous breathing
- Keywords
- spontaneous breathing, prone position, muscle paralysis
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine + spontaneous effortProcedure or surgery
without muscle paralysis in supine position
Supine + paralysisProcedure or surgery
administer muscle paralysis in supine position
Prone + paralysisProcedure or surgery
change the patient position from supine to prone with muscle paralysis
Prone + spontaneous breathingProcedure or surgery
cease the paralysis in supine position
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | all patients will receive all four intervention in the same sequential method Receives: Procedure: Supine + spontaneous effort; Procedure: Supine + paralysis; Procedure: Prone + paralysis; Procedure: Prone + spontaneous breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
spontaneous breathing
The intensity of spontaneous breathing during supine vs. prone estimated by an esophageal manometry
Measured: Through study completion (up to 24 hours)
Secondary outcomes (4)
inflammatory cytokines
IL-6 levels
Measured: Through study completion (up to 24 hours)
Trans-pulmonary pressure
Trans-pulmonary pressure
Measured: Through study completion (up to 24 hours)
electrical activity of diaphragm
electrical activity of diaphragm
Measured: Through study completion (up to 24 hours)
gas exchange
gas exchange
Measured: Through study completion (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Mar 2019
- Primary completion8 May 2020
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- Measurement 1 (Supine + spontaneous effort) , Measurement 2 (Supine + paralysis) , Measurement 3 (Prone + paralysis) , Measurement 4 (Prone + spontaneous breathing)
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Rebagliati
- Responsible party
- Sponsor
- Investigators
- Takeshi Yoshida, PhD, Principal investigator, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768154
- Sponsor's protocol ID
- PROSE
- Acronym
- PROSE
- Status last verified
- May 2020
- First submitted
- 15 Nov 2018
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Positioning and Spontaneous Breathing: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03768154
- Acronym / sponsor ID
- PROSE / PROSE
- Conditions
- Critical Illness, ARDS
- Keywords
- spontaneous breathing, prone position, muscle paralysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Hospital Rebagliati
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 7 Dec 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.
Spontaneous breathing during mechanical ventilation has been recommended in patients with ARDS and is currently used. in part because oxygenation is better and there is a lower risk of diaphragm dysfunction due to disuse. The other approach to minimizing lung injury from spontaneous effort is the use of neuromuscular blockade; an early and short term (48 hours) of neuromuscular blockade in patients with severe ARDS has been shown to decrease inflammation and to improve survival. The investigators propose a pilot study to test the feasibility and the physiological effects of allowing spontaneous breathing in the prone position in patients with ARDS.
Detailed description
The multi-center feasibility study will enroll 12 adult ARDS patients from the Intensive Care Units (ICUs) in Japan and Peru. Informed consent will be obtained from the patient or legally authorized substitute decision maker. Moderate-to-severe ARDS patients who are planned to turn to prone positioning, based on the attending physician's decisions will be included. Prior to initiating the protocol, patients will be sedated deeply with sedatives and/or opioids. Ventilator settings, physiological data, esophageal pressure and diaphragm activity will be recorded and physiological measurements will be collected for 5 minutes in supine (Measurement 1: Supine + spontaneous effort) . Patients will be paralyzed with a continuous infusion of rocuronium, and Measurement 2 (Supine + paralysis) will be recorded. The critical care team in the ICU change the position from supine to prone. After waiting for at least 1 hour in prone positioning, Measurement 3 (Prone + paralysis) will be recorded. Continuous infusion of rocuronium will be gradually decreased (and can be terminated) until spontaneous breathing will be observed without reaching an excessive level. The presence of spontaneous breathing will be evaluated by the negative swing of esophageal pressure, and Measurement 5 (Prone + spontaneous breathing) will be recorded.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Measurement 1 (Supine + spontaneous effort) , Measurement 2 (Supine + paralysis) , Measurement 3 (Prone + paralysis) , Measurement 4 (Prone + spontaneous breathing)
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Procedure: Supine + spontaneous effort, Procedure: Supine + paralysis, Procedure: Prone + paralysis, Procedure: Prone + spontaneous breathingall patients will receive all four intervention in the same sequential method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≧ 18 years old
- Patients with moderate-to-severe ARDS as per the Berlin definition
- Patients with esophageal balloon manometry
- Patients planned to turn to prone positioning, based on the attending physician's decisions
Key exclusion criteria (11 listed)
- Contraindication for prone positioning, referring to a previous randomized clinical trial
- Major hemodynamic instability:
- Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and two vasopressors or increase of vasopressor dose by 30% in the previous 6 hours.
- Contraindication to EIT electrode placement Burns, chest wall bandaging limiting electrode placement, pacemaker
- Clinical judgement of the attending physician against proning and/or spontaneous breathing
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 |
|---|---|---|
| Supine + spontaneous effortwithout muscle paralysis in supine position | Procedure or surgery | study arm |
| Supine + paralysisadminister muscle paralysis in supine position | Procedure or surgery | study arm |
| Prone + paralysischange the patient position from supine to prone with muscle paralysis | Procedure or surgery | study arm |
| Prone + spontaneous breathingcease the paralysis in supine position | Procedure or surgery | study arm |
Primary outcome
spontaneous breathing
Time frame: Through study completion (up to 24 hours)
The intensity of spontaneous breathing during supine vs. prone estimated by an esophageal manometry
4 secondary outcomes
inflammatory cytokines
Time frame: Through study completion (up to 24 hours)
Trans-pulmonary pressure
Time frame: Through study completion (up to 24 hours)
electrical activity of diaphragm
Time frame: Through study completion (up to 24 hours)
gas exchange
Time frame: Through study completion (up to 24 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Individual participant dataSharing planned: No
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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.
Takeshi Yoshida, PhD principal investigator
Osaka University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Supine + spontaneous effort, Supine + paralysis and Prone + paralysis in people with Critical Illness and ARDS, run by Osaka University at 1 site in Japan.
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 4 inclusion and 11 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 15 May 2020. 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 Japan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
spontaneous breathing (time frame: Through study completion (up to 24 hours)). 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 15 May 2020; AzTrials last refreshed its copy on 2 Nov 2026.