Prone Positioning and Spontaneous Breathing

NCT03768154 | Unknown Phase 1

• 1 other identifier: PROSE
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; ARDS

Keywords

spontaneous breathing; prone position; muscle paralysis

Outcome Measures

Primary Outcomes (1)

• spontaneous breathing

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

  Through study completion (up to 24 hours)

Secondary Outcomes (4)

• inflammatory cytokines

  Through study completion (up to 24 hours)

• Trans-pulmonary pressure

  Through study completion (up to 24 hours)

• electrical activity of diaphragm

  Through study completion (up to 24 hours)

• gas exchange

  Through study completion (up to 24 hours)

Study Arms (1)

study arm

EXPERIMENTAL

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

Procedure: Supine + spontaneous effort; Procedure: Supine + paralysis; Procedure: Prone + paralysis; Procedure: Prone + spontaneous breathing

Interventions

Supine + spontaneous effort PROCEDURE

without muscle paralysis in supine position

study arm

Supine + paralysis PROCEDURE

administer muscle paralysis in supine position

study arm

Prone + paralysis PROCEDURE

change the patient position from supine to prone with muscle paralysis

study arm

Prone + spontaneous breathing PROCEDURE

cease the paralysis in supine position

study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osaka University: lead
• Hospital Rebagliati: collaborator

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Supine Position; Prone Position

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Takeshi Yoshida, PhD

  Osaka University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Measurement 1 (Supine + spontaneous effort) , Measurement 2 (Supine + paralysis) , Measurement 3 (Prone + paralysis) , Measurement 4 (Prone + spontaneous breathing)

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: December 7, 2018
• Study Start: March 1, 2019
• Primary Completion: May 8, 2020
• Study Completion: March 31, 2021
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)