Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS.

April 11, 2024 updated by: Chien-Wei Hsu, Kaohsiung Veterans General Hospital.
Acute respiratory distress syndrome (ARDS) is a life-threatening disease, patients with ARDS usually need mechanical ventilation. The treatment of ARDS include low tidal volume ventilation, steroid, extracorporeal membraneous oxygenator, inhaled nitric oxide or prone position . Some studies showed prone position had beneficial effect of oxygenation and mortality for severe ARDS patients, the duration of prone position should be at least 10 hours. It is unknown the optimal duration of prone position which is better for severe ARDS patients. This study will compare the clinical differences of 16-hour and 24-hour prone position for severe ARDS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomized controlled study. All severe ARDS patients were eligible for screening from January 2020 to December 2022. Inclusion criteria include: Patient above 20 year-old with diagnosis of severe ARDS under protective lung ventilation( tidal volume 4-8 ml/kg, plateau pressure < 30cm H2O、PaO2/FiO2 < 150 mmHg、PEEP ≥ 5 cmH2O、FiO2 > 60%）. Patients were excluded if patients were not intubated and mechanically ventilated or contraindication for prone position ventilation (intracranial hemorrhage, massive hemoptysis, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy). Patients will divide into 2 groups, one is patients supported by 16-hour prone position; another group is patients with 24-hour prone position, each group enrolled 30 patients. The medical records of these patients were analyzed for age, gender, body weight, diagnosis, pulmonary or extrapulmonary ARDS, acute physiology and chronic health evaluation (APACHE) Ⅱscore, days between ARDS to prone position, ICU day, hospital day, ventilator day, pre and post prone position vital signs, laboratory data including arterial blood gas, lactate, respiratory parameters included PaO2/FiO2, peak inspiratory pressure, positive end-expiratory pressure, ventilator mode, steroid treatment, complications (tube dislodge, pressure sore, infection), and mortality outcomes.

The primary endpoint is the difference of oxygenation (PaO2/FiO2), the secondary endpoint are other respiratory parameters, vital signs, ICU day, hospital day, ventilator day, complications and survival.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient above 20 year-old with diagnosis of severe ARDS under protective lung ventilation (tidal volume 4-8 ml/kg, plateau pressure < 30cm H2O、PaO2/FiO2 < 150 mmHg、PEEP ≥ 5 cmH2O、FiO2 > 60%).

Exclusion Criteria:

  • Patients were not intubated and mechanically ventilated or contraindication for prone position ventilation (intracranial hemorrhage, massive hemoptysis, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 16-hour prone position
measure vital signs, PaO2/FiO2, driving pressure one hour before prone position and 1-hour, 8-hour, 16-hour after prone position
Procedure: prone position
a position with the patient lying face down with arms bent comfortably at the elbow and padded with the armboards positioned forward
Experimental: 24-hour prone position
measure vital signs, PaO2/FiO2, driving pressure one hour before prone position and 1-hour, 8-hour, 16-hour, 24- hour after prone position
Procedure: prone position
a position with the patient lying face down with arms bent comfortably at the elbow and padded with the armboards positioned forward

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxygenation
Time Frame: Change from baseline PaO2/FiO2 at 24-hour after prone position
PaO2/FiO2
Change from baseline PaO2/FiO2 at 24-hour after prone position

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory parameters
Time Frame: Change from baseline driving pressure at 24-hour after prone position
driving pressure
Change from baseline driving pressure at 24-hour after prone position
vital sign
Time Frame: Change from baseline driving pressure at 24-hour after prone position
blood pressure
Change from baseline driving pressure at 24-hour after prone position
duration of stay
Time Frame: up to 3 months
length of ICU stay
up to 3 months
complication
Time Frame: up to 3 months
sliding out of tube
up to 3 months
survival
Time Frame: one year
survival or death
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Chien Wei Hsu, MD, Kaohsiung VGH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2020

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VGHKS109-084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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