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Prone Positioning and Spontaneous Breathing (PROSE)

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ClinicalTrials.gov Identifier: NCT03768154
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Hospital Rebagliati
Information provided by (Responsible Party):
Osaka University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Critical Illness ARDS Procedure: Supine + spontaneous effort Procedure: Supine + paralysis Procedure: Prone + paralysis Procedure: Prone + spontaneous breathing Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Measurement 1 (Supine + spontaneous effort) , Measurement 2 (Supine + paralysis) , Measurement 3 (Prone + paralysis) , Measurement 4 (Prone + spontaneous breathing)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prone Positioning and Spontaneous Breathing: a Feasibility Study
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: study arm
all patients will receive all four intervention in the same sequential method
Procedure: Supine + spontaneous effort
without muscle paralysis in supine position

Procedure: Supine + paralysis
administer muscle paralysis in supine position

Procedure: Prone + paralysis
change the patient position from supine to prone with muscle paralysis

Procedure: Prone + spontaneous breathing
cease the paralysis in supine position




Primary Outcome Measures :
  1. spontaneous breathing [ Time Frame: Through study completion (up to 24 hours) ]
    Presence of spontaneous breathing while patients are under prone positioning.


Secondary Outcome Measures :
  1. inflammatory cytokines [ Time Frame: Through study completion (up to 24 hours) ]
    IL-6, IL-8 levels

  2. Trans-pulmonary pressure [ Time Frame: Through study completion (up to 24 hours) ]
    Trans-pulmonary pressure

  3. electrical activity of diaphragm [ Time Frame: Through study completion (up to 24 hours) ]
    electrical activity of diaphragm

  4. lung recruitment volume [ Time Frame: Through study completion (up to 24 hours) ]
    lung recruitment volume



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindication for prone positioning, referring to a previous randomized clinical trial

    1. Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mmHg
    2. Massive hemoptysis requiring an immediate surgical or interventional radiology procedure
    3. Tracheal surgery or sternotomy during the previous 15 days
    4. Serious facial trauma or facial surgery during the previous 15 days
    5. Cardiac pacemaker inserted in the last 2 days
    6. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768154


Contacts
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Contact: Takeshi Yoshida, PhD +81668795820 takeshiyoshida@hp-icu.med.osaka-u.ac.jp

Sponsors and Collaborators
Osaka University
Hospital Rebagliati
Investigators
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Principal Investigator: Takeshi Yoshida, PhD Osaka University

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Responsible Party: Osaka University
ClinicalTrials.gov Identifier: NCT03768154     History of Changes
Other Study ID Numbers: PROSE2018
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Osaka University:
spontaneous breathing
prone position
muscle paralysis

Additional relevant MeSH terms:
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Respiratory Aspiration
Critical Illness
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Disease Attributes