Effects of Respiratory Rehabilitation on ICU Patients
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
Effects of respiratory rehabilitation on patients after extubation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedStudy Start
First participant enrolled
December 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2021
CompletedDecember 16, 2020
December 1, 2020
4 months
April 22, 2020
December 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reintubation rates
The artificial airway was established again for invasive mechanical ventilation
28 days
Secondary Outcomes (15)
MRC，medical research council
28 days
30-STS
28 days
Barthel
28 days
Borg dyspnea score
28 days
oxygen partial pressure
28 days
- +10 more secondary outcomes
Study Arms (2)
Rehabilitation group
EXPERIMENTALTo conduct a comprehensive pulmonary rehabilitation assessment and treatment
Conventional medical group
NO INTERVENTIONConventional medical treatment
Interventions
Pulmonary rehabilitation (respiratory rehabilitation) is a comprehensive intervention based on a comprehensive patient assessment, targeted to the treatment of patients, including but not limited to exercise training, education and behavior change, aimed at improving the physical and mental health of patients with chronic respiratory diseases and promoting long-term adherence to health-enhancing behaviors.
Eligibility Criteria
You may qualify if:
- Aged above 18
- The hemodynamics are stable
- \< heart rate less than 120 beats/min
- \< systolic blood pressure \< 200mmHg
- \< mean arterial pressure \< 120mmHg
- Do not increase the dose of vasopressor for at least 2 hours
- Intracranial pressure was stable and there is no seizure within 24 hours
- The breathing condition is stable
- the oxygen satiety of the patient's finger vein is ≥88%
- \<the breathing frequency \< 35 times/min
You may not qualify if:
- Pregnancy
- Acute myocardial infarction (ami)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
PMID: 27706464BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
xin li xie, Ph.D.
Study Principal Investigator Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 22, 2020
First Posted
April 29, 2020
Study Start
December 20, 2020
Primary Completion
April 20, 2021
Study Completion
April 20, 2021
Last Updated
December 16, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share