Effects of Standing at Different Angles on Transpulmonary Pressure
Primary Purpose
Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Change of standing Angle
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Standing Angle
Arm Description
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
Outcomes
Primary Outcome Measures
transpulmonary pressure
End-expiratory pressure across the lungs is recommended at 0-5cmH2O.
Esophageal pressure
The change in esophageal pressure represents the degree of inspiratory effort.The greater the variation, the harder the inhale.
Dead space rate
the smaller,the better
tidal volume
Standard tidal volume: standard weight based on height, 6 to 8ml per kg body weight
partial pressure of carbon dioxide in endexpiratory gas
The smaller the difference between pCO2 and arterial blood gas, the better
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04451421
First Posted
June 26, 2020
Last Updated
July 1, 2020
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04451421
Brief Title
Effects of Standing at Different Angles on Transpulmonary Pressure
Official Title
Effects of Standing at Different Angles on Transpulmonary Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standing Angle
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Change of standing Angle
Intervention Description
Change the patient's standing Angle by using an electric bed
Primary Outcome Measure Information:
Title
transpulmonary pressure
Description
End-expiratory pressure across the lungs is recommended at 0-5cmH2O.
Time Frame
5 minutes
Title
Esophageal pressure
Description
The change in esophageal pressure represents the degree of inspiratory effort.The greater the variation, the harder the inhale.
Time Frame
5 minutes
Title
Dead space rate
Description
the smaller,the better
Time Frame
5 minutes
Title
tidal volume
Description
Standard tidal volume: standard weight based on height, 6 to 8ml per kg body weight
Time Frame
5 minutes
Title
partial pressure of carbon dioxide in endexpiratory gas
Description
The smaller the difference between pCO2 and arterial blood gas, the better
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
adverse reaction
Description
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.
Time Frame
an hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Ying
Phone
17600953801
Ext
17600953801
Email
1412888703@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xin li xie, Ph.D.
Organizational Affiliation
The First Medical Center of PLA General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Effects of Standing at Different Angles on Transpulmonary Pressure
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