NCT04451421

Brief Summary

Effects of standing at different angles on transpulmonary pressure

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

June 26, 2020

Last Update Submit

July 1, 2020

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (5)

  • transpulmonary pressure

    End-expiratory pressure across the lungs is recommended at 0-5cmH2O.

    5 minutes

  • Esophageal pressure

    The change in esophageal pressure represents the degree of inspiratory effort.The greater the variation, the harder the inhale.

    5 minutes

  • Dead space rate

    the smaller，the better

    5 minutes

  • tidal volume

    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

    The smaller the difference between pCO2 and arterial blood gas, the better

    5 minutes

Secondary Outcomes (1)

  • adverse reaction

    an hour

Study Arms (1)

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

Behavioral: Change of standing Angle

Interventions

Change of standing AngleBEHAVIORAL

Change the patient's standing Angle by using an electric bed

Standing Angle

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The age is ≥ 18 years old;
  • the hemodynamics is stable;
  • \< heart rate \< 120 beats / min ;
  • \< systolic blood pressure \< 200mmHg ;
  • \< 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%;
  • \< respiratory frequency \< 35 beats / min.

You may not qualify if:

  • Pregnancy;
  • acute cardio-cerebrovascular events;
  • spinal or limb fractures;
  • active bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • xin li xie, Ph.D.

    The First Medical Center of PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Ying

CONTACT

176009538011412888703@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 26, 2020

First Posted

June 30, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

July 7, 2020

Record last verified: 2020-06