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

NCT04391387 | Completed

• 1 other identifier: VGHKS109-084
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygenation; Driving Pressure

Keywords

acute respiratory distress syndrome; mechanical ventilation; oxygenation; prone position; protective lung ventilation

Outcome Measures

Primary Outcomes (1)

• oxygenation

  PaO2/FiO2

  Change from baseline PaO2/FiO2 at 24-hour after prone position

Secondary Outcomes (5)

• respiratory parameters

  Change from baseline driving pressure at 24-hour after prone position

• vital sign

  Change from baseline driving pressure at 24-hour after prone position

• duration of stay

  up to 3 months

• complication

  up to 3 months

• survival

  one year

Study Arms (2)

16-hour prone position

ACTIVE COMPARATOR

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

24-hour prone position

EXPERIMENTAL

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

Interventions

prone position PROCEDURE

a position with the patient lying face down with arms bent comfortably at the elbow and padded with the armboards positioned forward

16-hour prone position; 24-hour prone position

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify 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).

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (11)

• Fan E, Brodie D, Slutsky AS. Acute Respiratory Distress Syndrome: Advances in Diagnosis and Treatment. JAMA. 2018 Feb 20;319(7):698-710. doi: 10.1001/jama.2017.21907.

  PMID: 29466596 RESULT

• Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.

  PMID: 27400909 RESULT

• Sweeney RM, McAuley DF. Acute respiratory distress syndrome. Lancet. 2016 Nov 12;388(10058):2416-2430. doi: 10.1016/S0140-6736(16)00578-X. Epub 2016 Apr 28.

  PMID: 27133972 RESULT

• Alessandri F, Pugliese F, Ranieri VM. The Role of Rescue Therapies in the Treatment of Severe ARDS. Respir Care. 2018 Jan;63(1):92-101. doi: 10.4187/respcare.05752. Epub 2017 Oct 24.

  PMID: 29066591 RESULT

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 RESULT

• Drahnak DM, Custer N. Prone Positioning of Patients With Acute Respiratory Distress Syndrome. Crit Care Nurse. 2015 Dec;35(6):29-37. doi: 10.4037/ccn2015753.

  PMID: 26628543 RESULT

• Lee JM, Bae W, Lee YJ, Cho YJ. The efficacy and safety of prone positional ventilation in acute respiratory distress syndrome: updated study-level meta-analysis of 11 randomized controlled trials. Crit Care Med. 2014 May;42(5):1252-62. doi: 10.1097/CCM.0000000000000122.

  PMID: 24368348 RESULT

• 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.

  PMID: 28459336 RESULT

• Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

  PMID: 23688302 RESULT

• Beitler JR, Shaefi S, Montesi SB, Devlin A, Loring SH, Talmor D, Malhotra A. Prone positioning reduces mortality from acute respiratory distress syndrome in the low tidal volume era: a meta-analysis. Intensive Care Med. 2014 Mar;40(3):332-41. doi: 10.1007/s00134-013-3194-3. Epub 2014 Jan 17.

  PMID: 24435203 RESULT

• Tonelli AR, Zein J, Adams J, Ioannidis JP. Effects of interventions on survival in acute respiratory distress syndrome: an umbrella review of 159 published randomized trials and 29 meta-analyses. Intensive Care Med. 2014 Jun;40(6):769-87. doi: 10.1007/s00134-014-3272-1. Epub 2014 Mar 26.

  PMID: 24667919 RESULT

Related Links

• Valera, S. (2017). Mobilizing the ECMO patients: Prone positioning during venovenous extracorporeal membrane Oxygenation (vv ECMO). In C. Mossadegh \& A. Combes (Eds.), Nursing care and ECMO (pp. 75-82). Cham, Switzerland: Springer.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chien Wei Hsu, MD

  Kaohsiung VGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: May 18, 2020
• Study Start: July 9, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)