Acute Respiratory Distress SyndromeNCT05372731
Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients
A study testing Recruitment Maneuver in people with Acute Respiratory Distress Syndrome, run by Southeast University, China.
Trial summary
ARDS caused by pneumonia is one of the main reasons for ICU admission in critically ill patients, and also a common complication in patients admitted to ICU with invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Recruitment Maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2022to 30 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with invasive mechanical ventilation;
- Patients who diagnosed with ARDS according to the Berlin definition
- There are indications for bronchoalveolar lavage
Who cannot join
- Patients with contraindications for EIT procedures;
- Patients with contraindications for RM;
- Previous chronic respiratory diseases (long-term home oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD);
- Pregnancy;
- Refusal to sign informed consent
Trial locations and contacts
No sites are listed yet.
ling liu, phD contact
About this study
ARDS caused by pneumonia is one of the main reasons for ICU admission in critically ill patients, and also a common complication in patients admitted to ICU with invasive mechanical ventilation. Bronchoalveolar lavage (BAL) is the main diagnostic method for these patients, which often leads to alveolar collapse and exacerbates hypoxemia. In clinical practice, recruitment maneuver (RM) is often used immediately after BAL to prevent such a situation, but there is a lack of data on RM after BAL.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Recruitment Maneuver
- 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.
Recruitment ManeuverOther
RM after BAL
| Study group | Role | What they receive |
|---|---|---|
| RM after BAL | Experimental | patients underwent RM after BAL Receives: Other: Recruitment Maneuver |
| Non-RM after BAL | No intervention | patients did not undergo RM after BAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ratio of tidal volume in the BAL side and the other side
distribution of tidal volume monitored by electrical impedance tomography from the BAL side to the other side
Measured: up to 24 hours
Secondary outcomes (2)
partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio
partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio
Measured: up to 24 hours
respiratory system compliance (the tidal volume to the driving pressure ratio)
respiratory system compliance was calculated by dividing expiratory tidal volume by the driving pressure (plateau pressure minus positive end-expiratory pressure)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start30 Nov 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- ling liu, phD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372731
- Sponsor's protocol ID
- BAL20220420
- Status last verified
- Oct 2022
- First submitted
- 20 Apr 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients
- ClinicalTrials.gov ID
- NCT05372731
- Acronym / sponsor ID
- BAL20220420
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 30 Nov 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 May 2022 (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.
ARDS caused by pneumonia is one of the main reasons for ICU admission in critically ill patients, and also a common complication in patients admitted to ICU with invasive mechanical ventilation. Bronchoalveolar lavage (BAL) is the main diagnostic method for these patients, which often leads to alveolar collapse and exacerbates hypoxemia. In clinical practice, recruitment maneuver (RM) is often used immediately after BAL to prevent such a situation, but there is a lack of data on RM after BAL.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RM after BAL | Experimental | Other: Recruitment Maneuverpatients underwent RM after BAL |
| Non-RM after BAL | No intervention | –patients did not undergo RM after BAL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with invasive mechanical ventilation;
- Patients who diagnosed with ARDS according to the Berlin definition
- There are indications for bronchoalveolar lavage
Key exclusion criteria (5 listed)
- Patients with contraindications for EIT procedures;
- Patients with contraindications for RM;
- Previous chronic respiratory diseases (long-term home oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD);
- Pregnancy;
- Refusal to sign informed consent
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 |
|---|---|---|
| Recruitment ManeuverRM after BAL | Other | RM after BAL |
Primary outcome
the ratio of tidal volume in the BAL side and the other side
Time frame: up to 24 hours
distribution of tidal volume monitored by electrical impedance tomography from the BAL side to the other side
2 secondary outcomes
partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio
Time frame: up to 24 hours
respiratory system compliance (the tidal volume to the driving pressure ratio)
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- 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.
ling liu, phD contact
ling liu, phD principal investigator
Zhongda Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment Maneuver in people with Acute Respiratory Distress Syndrome, run by Southeast University, China.
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 3 inclusion and 5 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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ling liu, phD (86-25-83272201, liulingdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ratio of tidal volume in the BAL side and the other side (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2022.