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Prone Positioning and Spontaneous Breathing (PROSE)

Primary Purpose

Critical Illness, ARDS

Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Supine + spontaneous effort
Supine + paralysis
Prone + paralysis
Prone + spontaneous breathing
Sponsored by
Osaka University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring spontaneous breathing, prone position, muscle paralysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osaka University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study arm

Arm Description

all patients will receive all four intervention in the same sequential method

Outcomes

Primary Outcome Measures

spontaneous breathing
The intensity of spontaneous breathing during supine vs. prone estimated by an esophageal manometry

Secondary Outcome Measures

inflammatory cytokines
IL-6 levels
Trans-pulmonary pressure
Trans-pulmonary pressure
electrical activity of diaphragm
electrical activity of diaphragm
gas exchange
gas exchange

Full Information

First Posted
November 15, 2018
Last Updated
May 13, 2020
Sponsor
Osaka University
Collaborators
Hospital Rebagliati
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1. Study Identification

Unique Protocol Identification Number
NCT03768154
Brief Title
Prone Positioning and Spontaneous Breathing
Acronym
PROSE
Official Title
Prone Positioning and Spontaneous Breathing: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 8, 2020 (Actual)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osaka University
Collaborators
Hospital Rebagliati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, ARDS
Keywords
spontaneous breathing, prone position, muscle paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Measurement 1 (Supine + spontaneous effort) , Measurement 2 (Supine + paralysis) , Measurement 3 (Prone + paralysis) , Measurement 4 (Prone + spontaneous breathing)
Masking
None (Open Label)
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study arm
Arm Type
Experimental
Arm Description
all patients will receive all four intervention in the same sequential method
Intervention Type
Procedure
Intervention Name(s)
Supine + spontaneous effort
Intervention Description
without muscle paralysis in supine position
Intervention Type
Procedure
Intervention Name(s)
Supine + paralysis
Intervention Description
administer muscle paralysis in supine position
Intervention Type
Procedure
Intervention Name(s)
Prone + paralysis
Intervention Description
change the patient position from supine to prone with muscle paralysis
Intervention Type
Procedure
Intervention Name(s)
Prone + spontaneous breathing
Intervention Description
cease the paralysis in supine position
Primary Outcome Measure Information:
Title
spontaneous breathing
Description
The intensity of spontaneous breathing during supine vs. prone estimated by an esophageal manometry
Time Frame
Through study completion (up to 24 hours)
Secondary Outcome Measure Information:
Title
inflammatory cytokines
Description
IL-6 levels
Time Frame
Through study completion (up to 24 hours)
Title
Trans-pulmonary pressure
Description
Trans-pulmonary pressure
Time Frame
Through study completion (up to 24 hours)
Title
electrical activity of diaphragm
Description
electrical activity of diaphragm
Time Frame
Through study completion (up to 24 hours)
Title
gas exchange
Description
gas exchange
Time Frame
Through study completion (up to 24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Yoshida, PhD
Organizational Affiliation
Osaka University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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Prone Positioning and Spontaneous Breathing

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