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Prone Positioning and Spontaneous Breathing

NCT03768154 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-05-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hospital Rebagliati

    collaborator UNKNOWN

  • Osaka University

    lead OTHER

Principal Investigators

  • Takeshi Yoshida, PhD · Osaka University

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-05-08
Completion
2021-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03768154 on ClinicalTrials.gov