Back to resultsEarly Lung Rehabilitation Care for Patients After Double Lung Transplantation
Primary Purpose
Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Individualized lung rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Patients after double lung transplantation; informed consent
Exclusion Criteria:
- unstable condition
Sites / Locations
- SAHZhejiangU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Individualized lung rehabilitation programme
Arm Description
Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.
Outcomes
Primary Outcome Measures
ICU hospital stay
the stay time spent in ICU
Secondary Outcome Measures
Full Information
NCT ID
NCT04922879
First Posted
June 1, 2021
Last Updated
June 10, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04922879
Brief Title
Early Lung Rehabilitation Care for Patients After Double Lung Transplantation
Official Title
Early Lung Rehabilitation Care for Patients After Double Lung Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Develop appropriate individual programs for patients to implement lung rehabilitation safely and effectively.
Detailed Description
Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.
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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
experience summary
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individualized lung rehabilitation programme
Arm Type
Experimental
Arm Description
Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.
Intervention Type
Behavioral
Intervention Name(s)
Individualized lung rehabilitation
Intervention Description
Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.
Primary Outcome Measure Information:
Title
ICU hospital stay
Description
the stay time spent in ICU
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients after double lung transplantation; informed consent
Exclusion Criteria:
unstable condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Zeng
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
SAHZhejiangU
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Lung Rehabilitation Care for Patients After Double Lung Transplantation
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