- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04451421
Effects of Standing at Different Angles on Transpulmonary Pressure
July 1, 2020 updated by: wang kaifei, Chinese PLA General Hospital
Effects of standing at different angles on transpulmonary pressure
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhao Ying
- Phone Number: 17600953801 17600953801
- Email: 1412888703@qq.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- Pregnancy;
- acute cardio-cerebrovascular events;
- spinal or limb fractures;
- active bleeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standing Angle
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
|
Change the patient's standing Angle by using an electric bed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
transpulmonary pressure
Time Frame: 5 minutes
|
End-expiratory pressure across the lungs is recommended at 0-5cmH2O.
|
5 minutes
|
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.
|
5 minutes
|
Dead space rate
Time Frame: 5 minutes
|
the smaller,the better
|
5 minutes
|
tidal volume
Time Frame: 5 minutes
|
Standard tidal volume: standard weight based on height, 6 to 8ml per kg body weight
|
5 minutes
|
partial pressure of carbon dioxide in endexpiratory gas
Time Frame: 5 minutes
|
The smaller the difference between pCO2 and arterial blood gas, the better
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse reaction
Time Frame: an hour
|
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.
|
an hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: xin li xie, Ph.D., The First Medical Center of PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
June 26, 2020
First Submitted That Met QC Criteria
June 26, 2020
First Posted (Actual)
June 30, 2020
Study Record Updates
Last Update Posted (Actual)
July 7, 2020
Last Update Submitted That Met QC Criteria
July 1, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- transpulmonary pressure
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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