ICU Acquired WeaknessNCT04368286
Effects of Respiratory Rehabilitation on ICU Patients
A study testing pulmonary rehabilitation in people with ICU Acquired Weakness and Rehabilitation, run by Chinese PLA General Hospital.
Trial summary
Effects of respiratory rehabilitation on patients after extubation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness, Rehabilitation
- What is being tested?
- pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2020to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged above 18
- The hemodynamics are stable
- 50 < heart rate less than 120 beats/min
- 90 < systolic blood pressure < 200mmHg
- 55 < mean arterial pressure < 120mmHg
- Do not increase the dose of vasopressor for at least 2 hours
Show all 10Show fewer
- 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%
- 10<the breathing frequency < 35 times/min
Who cannot join
- Pregnancy
- Acute myocardial infarction (ami)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Respiratory Rehabilitation on Patients After Extubation
Effects of respiratory rehabilitation on patients after extubation
Read the detailed description
The purpose of this study is to evaluate whether sequential treatment with high-flow humidification therapy apparatus can improve the postoperative recovery and functional status of patients with invasive mechanical ventilation in ICU after the withdrawal of the catheter.Inclusion criteria: age 18-95;The hemodynamics were stable, that is, 50 < heart rate less than 120 beats/min, 90 < systolic blood pressure < 200mmHg, 55 < mean arterial pressure < 120mmHg.Do not increase the dose of vasopressor for at least 2 hours;Intracranial pressure was stable and there was no seizure within 24 hours.The breathing condition was stable, that is, the oxygen satiety of the patient's finger vein was ≥88%, and the breathing frequency was >10 and< 35 times/min.Exclusion criteria: pregnancy;Acute myocardial infarction.A total of 50 patients who are sequentially treated with high-flow humidification therapy apparatus after extubation in ICU are randomly assigned. The experimental group receive respiratory rehabilitation therapy, while the control group only receive routine medical treatment. All the enrolled patients underwent rehabilitation evaluation and bedside diaphragmatic ultrasound measurement.This study was approved by the Ethics Committee of the CPLA General Hospital (project No.2018-212-01). The following clinical datas were recorded for all patients through the unified database software: The rehabilitation program was formulated according to the cluster management strategy of ABCDEF and the six-step method of early activities.All of the patients in monitoring vital signs, every day at hospital group and all peripheral muscle MRC assessment, 30 s sit stand trial, modified Barthel index, Borg dyspnea score, arterial blood gas analysis, diaphragm ultrasonic monitoring by the bed, finally the experimental process on the patients whether using noninvasive ventilator, whether for endotracheal intubation again, whether to have new complications (pressure sores, aspiration, thrombosis, etc.) and the patients bed time statistics for the first time. Statistical analyses were conducted by SPSS 21.0 and a two-tailed P < 0.05 was considered significant.
- Conditions
- ICU Acquired Weakness, Rehabilitation
- Being tested
- pulmonary rehabilitation
- Keywords
- ICU，rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation group | Experimental | To conduct a comprehensive pulmonary rehabilitation assessment and treatment Receives: Behavioral: pulmonary rehabilitation |
| Conventional medical group | No intervention | Conventional medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation rates
The artificial airway was established again for invasive mechanical ventilation
Measured: 28 days
Secondary outcomes (15)
MRC，medical research council
medical research council，Assessment of peripheral muscle strength，total points0~60，less than 48scores means ICU aquired weaknesses.
Measured: 28 days
30-STS
30 second sit-to-stand test.The more times, has the better muscular endurance.
Measured: 28 days
Barthel
Assessment of activities of daily living.total points0~100，less than 60 scores means can't independent living.
Measured: 28 days
Borg dyspnea score
total points0~10,The higher the grade, the more difficulty breathing.
Measured: 28 days
oxygen partial pressure
Partial pressure of oxygen in arterial blood,normal range is 80~100.
Measured: 28 days
oxygenation index
The partial pressure of oxygen divided by the concentration of oxygen,Normal is greater than 400.
Measured: 28 days
The diaphragmatic excursion
The distance the diaphragm moves up and down during breathing,normal is 1.4cm.
Measured: 28 days
diaphragm contraction rate
The rate at which the diaphragm contracts during breathing,normal is 1.3cm/s.
Measured: 28 days
diaphragm thickness diaphragm thickness fraction
Thickness of diaphragm during breathing,(Diaphragm thickness at the end of inhalation-Diaphragm thickness at the end of exhalation)/Diaphragm thickness at the end of exhalation
Measured: 28 days
length of stay in ICU
Length of stay in ICU
Measured: three months
LOS(length of stay)
length of stay in hospital
Measured: three months
First time out of bed
First time out of bed by oneself
Measured: three months
Noninvasive utilization rate
Non-invasive ventilator usage
Measured: 28 days
mortality
Alive or Dead
Measured: 28 days
Complication rate
The incidence of new complications(pressure sores、thrombus、aspiration)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start20 Dec 2020 (estimated)
- Primary completion20 Apr 2021 (estimated)
- Study completion20 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
- Investigators
- xin li xie, Ph.D., Principal investigator, Study Principal Investigator Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368286
- Sponsor's protocol ID
- S2018-212-01
- Status last verified
- Dec 2020
- First submitted
- 22 Apr 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27706464
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Rehabilitation on Patients After Extubation
- ClinicalTrials.gov ID
- NCT04368286
- Acronym / sponsor ID
- S2018-212-01
- Conditions
- ICU Acquired Weakness, Rehabilitation
- Keywords
- ICU，rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 20 Dec 2020 (estimated)
- Primary completion
- 20 Apr 2021 (estimated)
- Study completion
- 20 Apr 2021 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of respiratory rehabilitation on patients after extubation
Detailed description
The purpose of this study is to evaluate whether sequential treatment with high-flow humidification therapy apparatus can improve the postoperative recovery and functional status of patients with invasive mechanical ventilation in ICU after the withdrawal of the catheter.Inclusion criteria: age 18-95;The hemodynamics were stable, that is, 50 < heart rate less than 120 beats/min, 90 < systolic blood pressure < 200mmHg, 55 < mean arterial pressure < 120mmHg.Do not increase the dose of vasopressor for at least 2 hours;Intracranial pressure was stable and there was no seizure within 24 hours.The breathing condition was stable, that is, the oxygen satiety of the patient's finger vein was ≥88%, and the breathing frequency was >10 and< 35 times/min.Exclusion criteria: pregnancy;Acute myocardial infarction.A total of 50 patients who are sequentially treated with high-flow humidification therapy apparatus after extubation in ICU are randomly assigned. The experimental group receive respiratory rehabilitation therapy, while the control group only receive routine medical treatment. All the enrolled patients underwent rehabilitation evaluation and bedside diaphragmatic ultrasound measurement.This study was approved by the Ethics Committee of the CPLA General Hospital (project No.2018-212-01). The following clinical datas were recorded for all patients through the unified database software: The rehabilitation program was formulated according to the cluster management strategy of ABCDEF and the six-step method of early activities.All of the patients in monitoring vital signs, every day at hospital group and all peripheral muscle MRC assessment, 30 s sit stand trial, modified Barthel index, Borg dyspnea score, arterial blood gas analysis, diaphragm ultrasonic monitoring by the bed, finally the experimental process on the patients whether using noninvasive ventilator, whether for endotracheal intubation again, whether to have new complications (pressure sores, aspiration, thrombosis, etc.) and the patients bed time statistics for the first time. Statistical analyses were conducted by SPSS 21.0 and a two-tailed P < 0.05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation group | Experimental | Behavioral: pulmonary rehabilitationTo conduct a comprehensive pulmonary rehabilitation assessment and treatment |
| Conventional medical group | No intervention | –Conventional medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged above 18
- The hemodynamics are stable
- 50 < heart rate less than 120 beats/min
- 90 < systolic blood pressure < 200mmHg
- 55 < mean arterial pressure < 120mmHg
Key exclusion criteria (2 listed)
- Pregnancy
- Acute myocardial infarction (ami)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary rehabilitationPulmonary 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. | Behavioural | Rehabilitation group |
Primary outcome
Reintubation rates
Time frame: 28 days
The artificial airway was established again for invasive mechanical ventilation
15 secondary outcomes
MRC，medical research council
Time frame: 28 days
30-STS
Time frame: 28 days
Barthel
Time frame: 28 days
Borg dyspnea score
Time frame: 28 days
oxygen partial pressure
Time frame: 28 days
oxygenation index
Time frame: 28 days
The diaphragmatic excursion
Time frame: 28 days
diaphragm contraction rate
Time frame: 28 days
diaphragm thickness diaphragm thickness fraction
Time frame: 28 days
length of stay in ICU
Time frame: three months
LOS(length of stay)
Time frame: three months
First time out of bed
Time frame: three months
Noninvasive utilization rate
Time frame: 28 days
mortality
Time frame: 28 days
Complication rate
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Background: PubMed 27706464Hernandez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xin li xie, Ph.D. principal investigator
Study Principal Investigator Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation in people with ICU Acquired Weakness and Rehabilitation, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ying zhao (+86 17600953801, 1412888703@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintubation rates (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.