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

NCT ID: NCT04391387

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2023-07-31

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.

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.

Conditions

Oxygenation; Driving Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

prone position

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

prone position

Intervention Type: PROCEDURE

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

Interventions

prone position

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

Intervention Type: PROCEDURE

Eligibility 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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role: lead

Responsible Party

Chien-Wei Hsu

attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chien Wei Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung VGH

Locations

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: RESULT

PMID: 29466596 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27400909 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27133972 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29066591 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26903337 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26628543 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24368348 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28459336 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23688302 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24435203 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24667919 (View on PubMed)

Related Links

https://link.springer.com/chapter/10.1007/978-3-319-20101-6_7

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.

Other Identifiers

VGHKS109-084

Identifier Type: -

Identifier Source: org_study_id