ARDSARDSNCT03237806
Effects of Sedation on Transpulmonary Pressure and Lung Homogenous
A study testing Deep sedated and Light sedated in people with ARDS, run by Southeast University, China at 1 site in China.
Trial summary
The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ARDS
- What is being tested?
- Deep sedated and Light sedated
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2015to 18 Mar 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:
- Requires positive pressure ventilation through an endotracheal tube
- Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
- PaO2/FiO2 less than 300 while receiving positive end-expiratory pressure (PEEP) at more than 5 cm H2O for at least 4 hours, with a duration of no more than 7 days
- No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)
- Surgical patient Surgical patient requires positive pressure ventilation through an endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)
Who cannot join
- Age younger than 18 years or older than 85 years
- Cardiac failure
- Known pregnancy
- Increased intracranial pressure
- Severe neuromuscular disease
- Recent injury or other pathologic condition of the esophagus
Show all 15Show fewer
- Pneumothorax
- Pleural effusion
- Diaphragmatic hernia
- Severe chronic respiratory disease
- End-stage chronic organ failure
- Expected survival of less than 24 hours
- Participation in another interventional study
- Attending physician declines to give consent for participant to enroll
- Patient or surrogate declines or is unable to give consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
About this study
Official title: Effects of Sedation on Transpulmonary Pressure and Lung Homogenous of ARDS Patients
The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near diaphram during mechanical ventilation, however, strong respiratory drive could generate more transpulmonary pressure in ARDS patients, which increase the stress and strain in injured lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of ARDS patients.The purpose of this study is to investigate the effects of sedation on transpulmonary pressure of ARDS patients.
Read the detailed description
Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast University
- Conditions
- ARDS
- Being tested
- Deep sedated, Light sedated
- Keywords
- ARDS,, Transpulmonary pressure,, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep sedatedDrug
Also called Deep sedation
Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)
Light sedatedDrug
Also called Light sedation
Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | In this phase, patients were sedated to the level of Ramsay 6 before Deep sedated or Light sedated |
| Deep sedation | Experimental | In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously Receives: Drug: Deep sedated |
| Light sedation | Experimental | In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously Receives: Drug: Light sedated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary pressure generate by patient during deep or light sedation
Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation
Measured: 15 minutes during deep or light sedation
Secondary outcomes (2)
static compliance of respiratory system
Crs measured during deep or light sedation
Measured: 15min during deep or light sedation
PaO2
ABG after deep or light sedation
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start31 May 2015
- Primary completion18 Jan 2018
- Study completion18 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Self control
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songqiao Liu, Southeast University, China
- Investigators
- Songqiao Liu, Doctor, Principal investigator, Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237806
- Sponsor's protocol ID
- 2012ZDIIKY22.0
- Acronym
- ARDS
- Status last verified
- Mar 2018
- First submitted
- 21 May 2014
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sedation on Transpulmonary Pressure and Lung Homogenous of ARDS Patients
- ClinicalTrials.gov ID
- NCT03237806
- Acronym / sponsor ID
- ARDS / 2012ZDIIKY22.0
- Conditions
- ARDS
- Keywords
- ARDS,, Transpulmonary pressure,, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 31 May 2015 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 3 Aug 2017 (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 acute respiratory distress syndrome (ARDS) is characterized by severe respiratory failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near diaphram during mechanical ventilation, however, strong respiratory drive could generate more transpulmonary pressure in ARDS patients, which increase the stress and strain in injured lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of ARDS patients.The purpose of this study is to investigate the effects of sedation on transpulmonary pressure of ARDS patients.
Detailed description
Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast University
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Self control
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –In this phase, patients were sedated to the level of Ramsay 6 before Deep sedated or Light sedated |
| Deep sedation | Experimental | Drug: Deep sedatedIn this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously |
| Light sedation | Experimental | Drug: Light sedatedIn this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:
- Surgical patient Surgical patient requires positive pressure ventilation through an endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)
Key exclusion criteria (15 listed)
- Age younger than 18 years or older than 85 years
- Cardiac failure
- Known pregnancy
- Increased intracranial pressure
- Severe neuromuscular disease
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 |
|---|---|---|
| Deep sedatedAlso: Deep sedationMidazolam intravenous continusly infusion, Deep sedated (Ramsay 5) | Drug | Deep sedation |
| Light sedatedAlso: Light sedationMidazolam intravenous continusly infusion, Light sedated (Ramsay 3) | Drug | Light sedation |
Primary outcome
Transpulmonary pressure generate by patient during deep or light sedation
Time frame: 15 minutes during deep or light sedation
Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation
2 secondary outcomes
static compliance of respiratory system
Time frame: 15min during deep or light sedation
PaO2
Time frame: 15 minutes
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 20 Mar 2018.
- 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.
Songqiao Liu, Doctor principal investigator
Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep sedated and Light sedated in people with ARDS, run by Southeast University, China at 1 site 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 6 inclusion and 15 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 20 Mar 2018. 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 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?
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?
Transpulmonary pressure generate by patient during deep or light sedation (time frame: 15 minutes during deep or light sedation). 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 20 Mar 2018.