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

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ClinicalTrials.gov Identifier: NCT04391387
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Chien-Wei Hsu, Kaohsiung Veterans General Hospital.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oxygenation Driving Pressure Procedure: prone position Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS.
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


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




Primary Outcome Measures :
  1. oxygenation [ Time Frame: Change from baseline PaO2/FiO2 at 24-hour after prone position ]
    PaO2/FiO2


Secondary Outcome Measures :
  1. respiratory parameters [ Time Frame: Change from baseline driving pressure at 24-hour after prone position ]
    driving pressure

  2. vital sign [ Time Frame: Change from baseline driving pressure at 24-hour after prone position ]
    blood pressure

  3. duration of stay [ Time Frame: up to 3 months ]
    length of ICU stay

  4. complication [ Time Frame: up to 3 months ]
    sliding out of tube

  5. survival [ Time Frame: one year ]
    survival or death



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391387


Contacts
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Contact: Chien Wei Hsu, MD 886-7-3422121 ext 2064 cwhsu2003@yahoo.com
Contact: PeiYu Chu, bachelor 886-7-3422121 ext 2064 a0912742188@gmail.com

Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Principal Investigator: Chien Wei Hsu, MD Kaohsiung VGH
Additional Information:
Publications of Results:
Fan E, Del Sorbo L, Goligher EC, Hodgson CL, Munshi L, Walkey AJ, Adhikari NKJ, Amato MBP, Branson R, Brower RG, Ferguson ND, Gajic O, Gattinoni L, Hess D, Mancebo J, Meade MO, McAuley DF, Pesenti A, Ranieri VM, Rubenfeld GD, Rubin E, Seckel M, Slutsky AS, Talmor D, Thompson BT, Wunsch H, Uleryk E, Brozek J, Brochard LJ; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 May 1;195(9):1253-1263. doi: 10.1164/rccm.201703-0548ST. Erratum in: Am J Respir Crit Care Med. 2017 Jun 1;195(11):1540.

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Responsible Party: Chien-Wei Hsu, attending physician, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT04391387    
Other Study ID Numbers: VGHKS109-084
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chien-Wei Hsu, Kaohsiung Veterans General Hospital.:
acute respiratory distress syndrome
mechanical ventilation
oxygenation
prone position
protective lung ventilation