Prone Positioning and Spontaneous Breathing

NCT ID: NCT03768154

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-03-31

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.

Conditions

Critical Illness; ARDS

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study arm

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

Group Type: EXPERIMENTAL

Supine + spontaneous effort

Intervention Type: PROCEDURE

without muscle paralysis in supine position

Supine + paralysis

Intervention Type: PROCEDURE

administer muscle paralysis in supine position

Prone + paralysis

Intervention Type: PROCEDURE

change the patient position from supine to prone with muscle paralysis

Prone + spontaneous breathing

Intervention Type: PROCEDURE

cease the paralysis in supine position

Interventions

Supine + spontaneous effort

without muscle paralysis in supine position

Intervention Type: PROCEDURE

Supine + paralysis

administer muscle paralysis in supine position

Intervention Type: PROCEDURE

Prone + paralysis

change the patient position from supine to prone with muscle paralysis

Intervention Type: PROCEDURE

Prone + spontaneous breathing

cease the paralysis in supine position

Intervention Type: PROCEDURE

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Rebagliati

UNKNOWN

Sponsor Role: collaborator

Osaka University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takeshi Yoshida, PhD

Role: PRINCIPAL_INVESTIGATOR

Osaka University

Locations

Osaka University Hospital

Suita, Osaka, Japan

Countries

Japan

Other Identifiers

PROSE

Identifier Type: -

Identifier Source: org_study_id