OxygenationNCT04391387
Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS.
A study testing prone position in people with Oxygenation and Driving Pressure, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial 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 . Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Oxygenation, Driving Pressure
- What is being tested?
- prone position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jul 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- prone position
- Keywords
- acute respiratory distress syndrome, mechanical ventilation, oxygenation, prone position, protective lung ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionProcedure or surgery
a position with the patient lying face down with arms bent comfortably at the elbow and padded with the armboards positioned forward
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation
PaO2/FiO2
Measured: Change from baseline PaO2/FiO2 at 24-hour after prone position
Secondary outcomes (5)
respiratory parameters
driving pressure
Measured: Change from baseline driving pressure at 24-hour after prone position
vital sign
blood pressure
Measured: Change from baseline driving pressure at 24-hour after prone position
duration of stay
length of ICU stay
Measured: up to 3 months
complication
sliding out of tube
Measured: up to 3 months
survival
survival or death
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start9 Jul 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Wei Hsu, Kaohsiung Veterans General Hospital.
- Investigators
- Chien Wei Hsu, MD, Principal investigator, Kaohsiung VGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391387
- Sponsor's protocol ID
- VGHKS109-084
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2020
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29466596Scholten 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.
PubMed 27400909Sweeney 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.
PubMed 27133972Alessandri 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.
PubMed 29066591Bellani 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.
PubMed 26903337Drahnak 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.
PubMed 26628543Lee 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.
PubMed 24368348Fan 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.
PubMed 28459336Guerin 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.
PubMed 23688302Beitler 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.
PubMed 24435203Tonelli 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.
PubMed 24667919
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS.
- ClinicalTrials.gov ID
- NCT04391387
- Acronym / sponsor ID
- VGHKS109-084
- Conditions
- Oxygenation, Driving Pressure
- Keywords
- acute respiratory distress syndrome, mechanical ventilation, oxygenation, prone position, protective lung ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 16-hour prone position | Active comparator | Procedure: prone positionmeasure vital signs, PaO2/FiO2, driving pressure one hour before prone position and 1-hour, 8-hour, 16-hour after prone position |
| 24-hour prone position | Experimental | Procedure: prone positionmeasure vital signs, PaO2/FiO2, driving pressure one hour before prone position and 1-hour, 8-hour, 16-hour, 24- hour after prone position |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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%).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prone positiona position with the patient lying face down with arms bent comfortably at the elbow and padded with the armboards positioned forward | Procedure or surgery | 16-hour prone position, 24-hour prone position |
Primary outcome
oxygenation
Time frame: Change from baseline PaO2/FiO2 at 24-hour after prone position
PaO2/FiO2
5 secondary outcomes
respiratory parameters
Time frame: 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
duration of stay
Time frame: up to 3 months
complication
Time frame: up to 3 months
survival
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Results publication: PubMed 29466596Fan 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.
- Results publication: PubMed 27400909Scholten 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.
- Results publication: PubMed 27133972Sweeney 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.
- Results publication: PubMed 29066591Alessandri 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.
- Results publication: PubMed 26903337Bellani 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.
- Results publication: PubMed 26628543Drahnak 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.
- Results publication: PubMed 24368348Lee 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.
- Results publication: PubMed 28459336Fan 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.
- Results publication: PubMed 23688302Guerin 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.
- Results publication: PubMed 24435203Beitler 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.
- Results publication: PubMed 24667919Tonelli 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien Wei Hsu, MD principal investigator
Kaohsiung VGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prone position in people with Oxygenation and Driving Pressure, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation (time frame: Change from baseline PaO2/FiO2 at 24-hour after prone position). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04391387, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.