Skip to content

Effects of Respiratory Rehabilitation on ICU Patients

Effects of Respiratory Rehabilitation on Patients After Extubation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04368286
Enrollment
100
Registered
2020-04-29
Start date
2020-12-20
Completion date
2021-04-20
Last updated
2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU Acquired Weakness, Rehabilitation

Keywords

ICU,rehabilitation

Brief summary

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.

Interventions

BEHAVIORALpulmonary rehabilitation

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.

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * 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

Exclusion criteria

* Pregnancy * Acute myocardial infarction (ami)

Design outcomes

Primary

MeasureTime frameDescription
Reintubation rates28 daysThe artificial airway was established again for invasive mechanical ventilation

Secondary

MeasureTime frameDescription
30-STS28 days30 second sit-to-stand test.The more times, has the better muscular endurance.
Barthel28 daysAssessment of activities of daily living.total points0\ 100,less than 60 scores means can't independent living.
Borg dyspnea score28 daystotal points0\ 10,The higher the grade, the more difficulty breathing.
oxygen partial pressure28 daysPartial pressure of oxygen in arterial blood,normal range is 80\ 100.
oxygenation index28 daysThe partial pressure of oxygen divided by the concentration of oxygen,Normal is greater than 400.
The diaphragmatic excursion28 daysThe distance the diaphragm moves up and down during breathing,normal is 1.4cm.
diaphragm contraction rate28 daysThe rate at which the diaphragm contracts during breathing,normal is 1.3cm/s.
MRC,medical research council28 daysmedical research council,Assessment of peripheral muscle strength,total points0\ 60,less than 48scores means ICU aquired weaknesses.
length of stay in ICUthree monthsLength of stay in ICU
LOS(length of stay)three monthslength of stay in hospital
First time out of bedthree monthsFirst time out of bed by oneself
Noninvasive utilization rate28 daysNon-invasive ventilator usage
mortality28 daysAlive or Dead
Complication rate28 daysThe incidence of new complications(pressure sores、thrombus、aspiration)
diaphragm thickness diaphragm thickness fraction28 daysThickness 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

Contacts

Primary Contactying zhao
1412888703@qq.com+86 17600953801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026