Pulmonary DiseaseNCT04451421
Effects of Standing at Different Angles on Transpulmonary Pressure
A study testing Change of standing Angle in people with Pulmonary Disease, run by Chinese PLA General Hospital.
Trial summary
Effects of standing at different angles on transpulmonary pressure Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Change of standing Angle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2021
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is ≥ 18 years old;
- the hemodynamics is stable;
- 50 < heart rate < 120 beats / min ;
- 90 < systolic blood pressure < 200mmHg ;
- 55 < mean arterial pressure < 120mmHg;
- do not increase the dose of pressor drugs for at least 2 hours;
Show all 10Show fewer
- intracranial pressure is stable and there are no seizures within 24 hours;
- the respiratory state is stable;
- the patient's finger pulse oxygen saturation ≥ 88%;
- 10 < respiratory frequency < 35 beats / min.
Who cannot join
- Pregnancy;
- acute cardio-cerebrovascular events;
- spinal or limb fractures;
- active bleeding.
Trial locations and contacts
No sites are listed yet.
About this study
Effects of standing at different angles on transpulmonary pressure
Read the detailed description
Objective: To study the effect of different standing angles on cross-lung pressure.Background: Long-term bed rest in ICU patients leads to upward movement of diaphragm and increased intrathoracic pressure in mechanically ventilated patients, resulting in lower cross-lung pressure. If the end-expiratory cross-lung pressure is negative, lung tissue compression and atelectasis will occur.Standing can lower the diaphragm, improve the pressure across the lungs, and improve ventilation.Selection methods: patients with invasive mechanical ventilation in the ICU, on the premise of stable hemodynamics, with the aid of electric bed training in standing in different angles, start from 20 degrees, 5 degrees up every five minutes, the largest up to 80 degrees, each Angle across the pulmonary pressure, die cavity ratio, tidal volume and breathe out carbon dioxide at the end of the record, and record whether low blood pressure, an accident in the process of take off the tube and other adverse reactions.
- Conditions
- Pulmonary Disease
- Being tested
- Change of standing Angle
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of standing AngleBehavioural
Change the patient's standing Angle by using an electric bed
| Study group | Role | What they receive |
|---|---|---|
| Standing Angle | Experimental | Assist the electric hospital bed to conduct different Angle standing training, starting from 20 degrees, every five minutes to rise 5 degrees, the maximum rise to 80 degrees Receives: Behavioral: Change of standing Angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
transpulmonary pressure
End-expiratory pressure across the lungs is recommended at 0-5cmH2O.
Measured: 5 minutes
Esophageal pressure
The change in esophageal pressure represents the degree of inspiratory effort.The greater the variation, the harder the inhale.
Measured: 5 minutes
Dead space rate
the smaller，the better
Measured: 5 minutes
tidal volume
Standard tidal volume: standard weight based on height, 6 to 8ml per kg body weight
Measured: 5 minutes
partial pressure of carbon dioxide in endexpiratory gas
The smaller the difference between pCO2 and arterial blood gas, the better
Measured: 5 minutes
Secondary outcomes (1)
adverse reaction
hypotension、Accident to take off the tube、Drop of bed，Record the number of times it happens.The more it happens, the less safe it is.
Measured: an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
- Investigators
- xin li xie, Ph.D., Principal investigator, The First Medical Center of PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451421
- Sponsor's protocol ID
- transpulmonary pressure
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standing at Different Angles on Transpulmonary Pressure
- ClinicalTrials.gov ID
- NCT04451421
- Acronym / sponsor ID
- transpulmonary pressure
- Conditions
- Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 30 Jun 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.
Effects of standing at different angles on transpulmonary pressure
Detailed description
Objective: To study the effect of different standing angles on cross-lung pressure.Background: Long-term bed rest in ICU patients leads to upward movement of diaphragm and increased intrathoracic pressure in mechanically ventilated patients, resulting in lower cross-lung pressure. If the end-expiratory cross-lung pressure is negative, lung tissue compression and atelectasis will occur.Standing can lower the diaphragm, improve the pressure across the lungs, and improve ventilation.Selection methods: patients with invasive mechanical ventilation in the ICU, on the premise of stable hemodynamics, with the aid of electric bed training in standing in different angles, start from 20 degrees, 5 degrees up every five minutes, the largest up to 80 degrees, each Angle across the pulmonary pressure, die cavity ratio, tidal volume and breathe out carbon dioxide at the end of the record, and record whether low blood pressure, an accident in the process of take off the tube and other adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standing Angle | Experimental | Behavioral: Change of standing AngleAssist the electric hospital bed to conduct different Angle standing training, starting from 20 degrees, every five minutes to rise 5 degrees, the maximum rise to 80 degrees |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The age is ≥ 18 years old;
- the hemodynamics is stable;
- 50 < heart rate < 120 beats / min ;
- 90 < systolic blood pressure < 200mmHg ;
- 55 < mean arterial pressure < 120mmHg;
Key exclusion criteria (4 listed)
- Pregnancy;
- acute cardio-cerebrovascular events;
- spinal or limb fractures;
- active bleeding.
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 |
|---|---|---|
| Change of standing AngleChange the patient's standing Angle by using an electric bed | Behavioural | Standing Angle |
Primary outcome
transpulmonary pressure
Time frame: 5 minutes
End-expiratory pressure across the lungs is recommended at 0-5cmH2O.
Esophageal pressure
Time frame: 5 minutes
The change in esophageal pressure represents the degree of inspiratory effort.The greater the variation, the harder the inhale.
Dead space rate
Time frame: 5 minutes
the smaller，the better
tidal volume
Time frame: 5 minutes
Standard tidal volume: standard weight based on height, 6 to 8ml per kg body weight
partial pressure of carbon dioxide in endexpiratory gas
Time frame: 5 minutes
The smaller the difference between pCO2 and arterial blood gas, the better
1 secondary outcome
adverse reaction
Time frame: an hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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.
xin li xie, Ph.D. principal investigator
The First Medical Center of PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Change of standing Angle in people with Pulmonary Disease, run by Chinese PLA General Hospital.
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 10 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 7 Jul 2020. 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 Zhao Ying (17600953801 ext. 17600953801, 1412888703@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transpulmonary pressure (time frame: 5 minutes). The study lists 5 primary outcomes in all. 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 7 Jul 2020.