ARDSARDSNCT05023226
Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS
A study testing RM and LPVS in people with ARDS, run by Asia University at 1 site in Taiwan.
Trial summary
The study was designed to comparison the effectiveness of recruitment maneuvers(RM) and lung protective ventilation strategy(LPVS) for patients with moderate to severe ARDS. ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- ARDS
- What is being tested?
- RM and LPVS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Oct 2021to 31 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 70 years old.
- Patients with hypoxemia receiving endotracheal mechanical ventilation therapy.
- The ARDS diagnostic criteria of Berlin Definition, arterial oxygen tension [PaO2]/fractional inspired oxygen [FiO2] ratio (PaO2/FiO2) <200 mm Hg, recent appearance of bilateral pulmonary infiltrates consistent with edema and no clinical evidence of left atrial hypertension.
- Within 72 hours after ARDS diagnosis.
Who cannot join
- Pregnancy.
- Participate in other interventional trials at the same time during the acceptance period.
- Severe trauma combined with rib fracture or pneumothorax, subcutaneous emphysema, and mediastinal air accumulation within three months.
- Severe chronic respiratory diseases that require long-term use of oxygen therapy or home mechanical ventilation.
- Have a history of cachexia or terminal cancer.
- Use immunosuppressants, chemotherapy or radiation therapy.
- Contraindications for hypercapnia, such as patients with acute brain injury due to intracranial hypertension or craniotomy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Asia University
Taichung, Wufeng, 41354
Jiun-Yi Wang, Ph.D., 886-42332-3456 ext. 1861, jjwang@asia.edu.tw
About this study
The study was designed to comparison the effectiveness of recruitment maneuvers(RM) and lung protective ventilation strategy(LPVS) for patients with moderate to severe ARDS.
ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.
Read the detailed description
ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.
- Conditions
- ARDS
- Being tested
- RM, LPVS
- Keywords
- Acute respiratory distress syndrome (ARDS), Recruitment maneuvers (RM), Oxygenation index(OI), Lung ultrasound score(LUS)
- 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.
RMProcedure or surgery
Also called Recruitment maneuver
RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the level was fixed to 40 seconds in each increment. Then, the ventilator was transferred to PEEP-titration phase, the PEEP was adjusted to 25 cm H2O, and it was reduced by increments of 5 cm H2O each time. The each increment was fixed to 5 minutes till the end-maneuver PEEP.
LPVSProcedure or surgery
Also called Lung protective ventilation strategies
LPVS was used by the pressure-controlled mode and the PEEP was titrated by the level of FiO2 to keep the saturation of oxygen (SaO2) more than 90%. The level of pressure control was adjusted to maintain low tidal volume (6-8 mL/kg predicted body weight [PBW]) strategy. The respiratory rate and tidal volume were setting to avoid unstable hemodynamic data and adjusted by blood gas data and lung mechanics.
| Study group | Role | What they receive |
|---|---|---|
| LPVS group | Placebo comparator | The general ventilator setting. Receives: Procedure: LPVS |
| LPVS + RM group | Experimental | Recruitment maneuver. Receives: Procedure: RM; Procedure: LPVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index(OI)
Difference in OI between baseline and 72 hrs after enrollment 【The oxygenation index assesses the intensity of ventilatory support that is needed to maintain adequate oxygenation. The formula is: Oxygenation index = (FiO2 x PAW) / PaO2. The lower the OI(<25) the better the outcome】
Measured: Baseline - 72 hrs after enrollment
Lung ultrasound score(LUS)
Difference in LUS between baseline and 72 hrs after enrollment 【LUS is a score that measures lung aeration, score ranging from 0 to 36 points, the higher the score is mean the worse the ventilation of the lungs】
Measured: Baseline - 72 hrs after enrollment
Secondary outcomes (3)
Ventilator days
Removal of endotracheal tube without ventilator support days
Measured: Removal of endotracheal tube day - Insertion endotracheal tube day + 1 day
Length of stay in the ICU (days)
Total days of admission ICU
Measured: Transfer out of ICU day - Admission to ICU day + 1 day
ICU mortality
In ICU death after admission to the ICU
Measured: During ICU course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start5 Oct 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zi-Tin Kuan, RN, Study director, Asia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023226
- Sponsor's protocol ID
- AUH-CT-ZK01
- Acronym
- ARDS
- Status last verified
- Jan 2023
- First submitted
- 21 Aug 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung FT, Lee CS, Lin SM, Kuo CH, Wang TY, Fang YF, Hsieh MH, Chen HC, Lin HC. Alveolar recruitment maneuver attenuates extravascular lung water in acute respiratory distress syndrome. Medicine (Baltimore). 2017 Jul;96(30):e7627. doi: 10.1097/MD.0000000000007627.
PubMed 28746224
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Recruitment Maneuvers and Lung Protective Ventilation Strategy in ARDS
- ClinicalTrials.gov ID
- NCT05023226
- Acronym / sponsor ID
- ARDS / AUH-CT-ZK01
- Conditions
- ARDS
- Keywords
- Acute respiratory distress syndrome (ARDS), Recruitment maneuvers (RM), Oxygenation index(OI), Lung ultrasound score(LUS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 26 Aug 2021 (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.
The study was designed to comparison the effectiveness of recruitment maneuvers(RM) and lung protective ventilation strategy(LPVS) for patients with moderate to severe ARDS.
ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.
Detailed description
ARDS patients were randomly divided into two groups, the experimental group (LPVS+RM group) and the control group (LPVS group). The method of RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the arterial blood oxygen is monitored at the same time. The pressure point when the partial pressure of arterial oxygen PaO2+PaCO2≧400mmHg is the best PEEP. The primary endpoint indicators were oxygenation index(OI) and lung ultrasound score(LUS) from day 1 to day 7. The secondary outcome indicators were the ventilator days, length of stay in the ICU (days), and ICU mortality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPVS group | Placebo comparator | Procedure: LPVSThe general ventilator setting. |
| LPVS + RM group | Experimental | Procedure: RM, Procedure: LPVSRecruitment maneuver. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 to 70 years old.
- Patients with hypoxemia receiving endotracheal mechanical ventilation therapy.
- The ARDS diagnostic criteria of Berlin Definition, arterial oxygen tension [PaO2]/fractional inspired oxygen [FiO2] ratio (PaO2/FiO2) <200 mm Hg, recent appearance of bilateral pulmonary infiltrates consistent with edema and no clinical evidence of left atrial hypertension.
- Within 72 hours after ARDS diagnosis.
Key exclusion criteria (7 listed)
- Pregnancy.
- Participate in other interventional trials at the same time during the acceptance period.
- Severe trauma combined with rib fracture or pneumothorax, subcutaneous emphysema, and mediastinal air accumulation within three months.
- Severe chronic respiratory diseases that require long-term use of oxygen therapy or home mechanical ventilation.
- Have a history of cachexia or terminal cancer.
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 |
|---|---|---|
| RMAlso: Recruitment maneuverRM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the level was fixed to 40 seconds in each increment. Then, the ventilator was transferred to PEEP-titration phase, the PEEP was adjusted to 25 cm H2O, and it was reduced by increments of 5 cm H2O each time. The each increment was fixed to 5 minutes till the end-maneuver PEEP. | Procedure or surgery | LPVS + RM group |
| LPVSAlso: Lung protective ventilation strategiesLPVS was used by the pressure-controlled mode and the PEEP was titrated by the level of FiO2 to keep the saturation of oxygen (SaO2) more than 90%. The level of pressure control was adjusted to maintain low tidal volume (6-8 mL/kg predicted body weight [PBW]) strategy. The respiratory rate and tidal volume were setting to avoid unstable hemodynamic data and adjusted by blood gas data and lung mechanics. | Procedure or surgery | LPVS + RM group, LPVS group |
Primary outcome
Oxygenation index(OI)
Time frame: Baseline - 72 hrs after enrollment
Difference in OI between baseline and 72 hrs after enrollment 【The oxygenation index assesses the intensity of ventilatory support that is needed to maintain adequate oxygenation. The formula is: Oxygenation index = (FiO2 x PAW) / PaO2. The lower the OI(<25) the better the outcome】
Lung ultrasound score(LUS)
Time frame: Baseline - 72 hrs after enrollment
Difference in LUS between baseline and 72 hrs after enrollment 【LUS is a score that measures lung aeration, score ranging from 0 to 36 points, the higher the score is mean the worse the ventilation of the lungs】
3 secondary outcomes
Ventilator days
Time frame: Removal of endotracheal tube day - Insertion endotracheal tube day + 1 day
Length of stay in the ICU (days)
Time frame: Transfer out of ICU day - Admission to ICU day + 1 day
ICU mortality
Time frame: During ICU course
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Results publication: PubMed 28746224Chung FT, Lee CS, Lin SM, Kuo CH, Wang TY, Fang YF, Hsieh MH, Chen HC, Lin HC. Alveolar recruitment maneuver attenuates extravascular lung water in acute respiratory distress syndrome. Medicine (Baltimore). 2017 Jul;96(30):e7627. doi: 10.1097/MD.0000000000007627.
- doi: 10.1097/MD.0000000000007627Link 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.
Zi-Tin Kuan, RN study director
Asia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RM and LPVS in people with ARDS, run by Asia University 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zi-Tin Kuan, RN (886-966083885, kuan.zitin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation index(OI) (time frame: Baseline - 72 hrs after enrollment). The study lists 2 primary outcomes in all. 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 NCT05023226, which also lists 1 linked publication.
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 1 Feb 2023.