Acute Respiratory Distress SyndromeDEOTRMOARDSNCT02387437
Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome
A study testing SI recruitment, IP recruitment and PCV recruitment in people with Acute Respiratory Distress Syndrome, run by Southeast University, China at 2 sites in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is the common disease in clinical, which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- SI recruitment, IP recruitment and PCV recruitment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2014to Jan 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are severe or moderate ARDS
- Patients who have signed ICF
Who cannot join
- Patients who are younger than 18 years old or older than 75 years old
- Patients whose vital signs are unstable
- Patients who are in other clinical trails
- Patients who are pregnant
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhongda hospital, Southeast University
Nanjing, Jiangsu, 210009
Chun Pan, Dr, +862583262550, panchun1982@gmail.com
- Recruiting
Zhongda hospital, Southeast University
Nanjing, Jiangsu, 210009
Lihui Wang, Dr, +861580516055, Lihui_Wang0622@126.com
About this study
Official title: Evaluation of Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) is the common disease in clinical, which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.
Read the detailed description
Acute respiratory distress syndrome (ARDS) is the common disease in clinical,which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.
Electrical impedance tomography (EIT) has been introduced as a true bedside and radiation-free technique which provides information on heterogeneity. The investigators compare effects of three recruitment maneuvers on lung heterogeneity before recruitment maneuver and do the same thing after three recruitment maneuvers.
Ninety-three patients with ARDS will be enrolled . These patients are treated routinly.They need to recept a time of ZEEP (PEEP is zero cmH2O)for ten respiratory cycles before RM(recruitment maneuvers).Implemente a kind of RM at random immediately after ZEEP,Then make the ventilator same as before ZEEP.The EIT images ,blood gases and hemodynamic variables will be examined as beseline between ZEEP and RM.Completion of this kind of RM lies that the P/F of blood gases 3 minutes after RM achieves (1) PO2/FiO2>400mmHg or (2)PO2/FiO2+PCO2 ≥ 400mmHg(FiO2=1)，(3)the difference between this index before lung recriument and after lung recriument PO2/FiO2<5%.In addition,3 minutes after RM,compare the indexs above between three methods.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- SI recruitment, IP recruitment, PCV recruitment
- Keywords
- ARDS, EIT, recruitment maneuvers
- 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.
SI recruitmentBehavioural
SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs.
IP recruitmentBehavioural
Incremental positive end-expiratory pressure (PEEP) with a fixed peak pressure (IP), PEEP increased in 5 cm H2O increments (allowing 30 secs/step) from a baseline PEEP of post-trial to 40 cm H2O while decreasing tidal volume to limit peak inspiratory pressure to 40 cm H2O. After CPAP of 40 cm H2O was held for 30 secs, PEEP was decremented in 5-cm H2O steps to the post-RM PEEP setting, while increasing tidal volume toward the baseline value of 10 mL/kg (as the 40 cm H2O peak pressure limit allowed).
PCV recruitmentBehavioural
PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min
| Study group | Role | What they receive |
|---|---|---|
| SI recruitment | Experimental | Compare the effect of three recruitment maneuvers before and after recruitment maneuvers is implemented,SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs. Receives: Behavioral: SI recruitment; Behavioral: IP recruitment; Behavioral: PCV recruitment |
| IP recruitment | Experimental | Compare the effect of three recruitment maneuvers before and after recruitment maneuvers is implemented,Incremental positive end-expiratory pressure (PEEP) with a fixed peak pressure (IP), PEEP increased in 5 cm H2O increments (allowing 30 secs/step) from a baseline PEEP of post-trial to 40 cm H2O while decreasing tidal volume to limit peak inspiratory pressure to 40 cm H2O. After CPAP of 40 cm H2O was held for 30 secs, PEEP was decremented in 5-cm H2O steps to the post-RM PEEP setting, while increasing tidal volume toward the baseline value of 10 mL/kg (as the 40 cm H2O peak pressure limit allowed). Receives: Behavioral: SI recruitment; Behavioral: IP recruitment; Behavioral: PCV recruitment |
| PCV recruitment | Experimental | Compare the effect of three recruitment maneuvers before and after recruitment maneuvers is implemented,PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min Receives: Behavioral: SI recruitment; Behavioral: IP recruitment; Behavioral: PCV recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation (improvement of oxygenation)
detection of index 3 minutes after lung recruiment (1) PO2/FiO2>400mmHg or (2)PO2/FiO2+PCO2 ≥ 400mmHg(FiO2=1)，(3)the difference between this index before lung recriument and after lung recriument PO2/FiO2<5%
Measured: improvement of oxygenation 3 minutes after lung recruiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongda Hospital
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Yingzi Huang, Study director, southeast univerity, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387437
- Sponsor's protocol ID
- 2014ZDSYLL124.1
- Acronym
- DEOTRMOARDS
- Status last verified
- Dec 2014
- First submitted
- 4 Feb 2015
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02387437
- Acronym / sponsor ID
- DEOTRMOARDS / 2014ZDSYLL124.1
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, EIT, recruitment maneuvers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Zhongda Hospital
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 13 Mar 2015 (estimated)
- 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 the common disease in clinical, which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.
Detailed description
Acute respiratory distress syndrome (ARDS) is the common disease in clinical,which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.
Electrical impedance tomography (EIT) has been introduced as a true bedside and radiation-free technique which provides information on heterogeneity. The investigators compare effects of three recruitment maneuvers on lung heterogeneity before recruitment maneuver and do the same thing after three recruitment maneuvers.
Ninety-three patients with ARDS will be enrolled . These patients are treated routinly.They need to recept a time of ZEEP (PEEP is zero cmH2O)for ten respiratory cycles before RM(recruitment maneuvers).Implemente a kind of RM at random immediately after ZEEP,Then make the ventilator same as before ZEEP.The EIT images ,blood gases and hemodynamic variables will be examined as beseline between ZEEP and RM.Completion of this kind of RM lies that the P/F of blood gases 3 minutes after RM achieves (1) PO2/FiO2>400mmHg or (2)PO2/FiO2+PCO2 ≥ 400mmHg(FiO2=1)，(3)the difference between this index before lung recriument and after lung recriument PO2/FiO2<5%.In addition,3 minutes after RM,compare the indexs above between three methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SI recruitment | Experimental | Behavioral: SI recruitment, Behavioral: IP recruitment, Behavioral: PCV recruitmentCompare the effect of three recruitment maneuvers before and after recruitment maneuvers is implemented,SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs. |
| IP recruitment | Experimental | Behavioral: SI recruitment, Behavioral: IP recruitment, Behavioral: PCV recruitmentCompare the effect of three recruitment maneuvers before and after recruitment maneuvers is implemented,Incremental positive end-expiratory pressure (PEEP) with a fixed peak pressure (IP), PEEP increased in 5 cm H2O increments (allowing 30 secs/step) from a baseline PEEP of post-trial to 40 cm H2O while decreasing tidal volume to limit peak inspiratory pressure to 40 cm H2O. After CPAP of 40 cm H2O was held for 30 secs, PEEP was decremented in 5-cm H2O steps to the post-RM PEEP setting, while increasing tidal volume toward the baseline value of 10 mL/kg (as the 40 cm H2O peak pressure limit allowed). |
| PCV recruitment | Experimental | Behavioral: SI recruitment, Behavioral: IP recruitment, Behavioral: PCV recruitmentCompare the effect of three recruitment maneuvers before and after recruitment maneuvers is implemented,PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are severe or moderate ARDS
- Patients who have signed ICF
Key exclusion criteria (4 listed)
- Patients who are younger than 18 years old or older than 75 years old
- Patients whose vital signs are unstable
- Patients who are in other clinical trails
- Patients who are pregnant
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 |
|---|---|---|
| SI recruitmentSI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs. | Behavioural | IP recruitment, PCV recruitment, SI recruitment |
| IP recruitmentIncremental positive end-expiratory pressure (PEEP) with a fixed peak pressure (IP), PEEP increased in 5 cm H2O increments (allowing 30 secs/step) from a baseline PEEP of post-trial to 40 cm H2O while decreasing tidal volume to limit peak inspiratory pressure to 40 cm H2O. After CPAP of 40 cm H2O was held for 30 secs, PEEP was decremented in 5-cm H2O steps to the post-RM PEEP setting, while increasing tidal volume toward the baseline value of 10 mL/kg (as the 40 cm H2O peak pressure limit allowed). | Behavioural | IP recruitment, PCV recruitment, SI recruitment |
| PCV recruitmentPCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min | Behavioural | IP recruitment, PCV recruitment, SI recruitment |
Primary outcome
oxygenation (improvement of oxygenation)
Time frame: improvement of oxygenation 3 minutes after lung recruiment
detection of index 3 minutes after lung recruiment (1) PO2/FiO2>400mmHg or (2)PO2/FiO2+PCO2 ≥ 400mmHg(FiO2=1)，(3)the difference between this index before lung recriument and after lung recriument PO2/FiO2<5%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
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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.
Yingzi Huang study director
southeast univerity, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SI recruitment, IP recruitment and PCV recruitment in people with Acute Respiratory Distress Syndrome, run by Southeast University, China at 2 sites in 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 2 inclusion and 4 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 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation (improvement of oxygenation) (time frame: improvement of oxygenation 3 minutes after lung recruiment). 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 13 Mar 2015.