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Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04441151
Enrollment
70
Registered
2020-06-22
Start date
2025-03-20
Completion date
2026-02-01
Last updated
2026-02-09

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

Conditions

Pulmonary Disease

Brief summary

Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy

Detailed description

Objective: the purpose of this study was to evaluate the effect of lung rehabilitation on patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU who were treated with high flow humidification apparatus from June 2019 to June 2020 were randomly divided into two groups. The experimental group was treated with pulmonary rehabilitation and the control group was treated with routine medical treatment only. All patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally, statistics were made on the use of non-invasive ventilator, endotracheal intubation, new complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting out of bed for the first time.The end point of the experiment was 28 days.

Interventions

Comprehensive interventions based on comprehensive evaluation and customization of patients, including, but not limited to, exercise training, education and behavioral changes, aimed at improving the physiological and psychological status of patients with chronic respiratory diseases, and urge patients to adhere to health promotion activities for a long time.

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* The age is ≥ 18 years old; * the hemodynamics is stable; * 50 \< heart rate \< 120 beats / min ; * 90 \< systolic blood pressure \< 200mmHg ; * 55 \< 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%; * 10 \< respiratory frequency \< 35 beats / min.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
PaO2Day 28arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80\~100.
Oxygenation indexDay 28arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.
Diaphragm mobilityDay 28The distance the diaphragm drops during inhalation,normal is 1.4cm.
Diaphragm contraction velocityDay 28The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.
End-inspiratory diaphragm thicknessDay 28The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.
MRCDay 28Medical Research Council,Muscle strength assessment,total points0\~60,less than 48scores means ICU aquired weaknesses.
STSDay 28Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.
barthel indexDay 28barthel index,Daily activity assessment,Assessment of activities of daily living.total points0\~100,less than 60 scores means can't independent living.
Borg dyspnea scoreDay 28Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe
End-expiratory diaphragm thicknessDay 28The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.
Diaphragm thickness variation rateDay 28Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.

Secondary

MeasureTime frameDescription
ICU stay time3 monthicu length of stay
Hospitalization timeMonth 3Hospitalization time,length of stay in hospital.
The time it takes to get out of bed for the first timeDay 28The time it takes to get out of bed for the first time
Use of non-invasive ventilatorDay 28Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.
IntubationDay 28Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days
mortalityDay 28mortality
ComplicationDay 28The incidence of new complications(pressure sores、thrombus、aspiration).

Countries

China

Contacts

CONTACTkai fei Wang
zhaoying301301@163.com+861055499330
PRINCIPAL_INVESTIGATORwang, doctor

The First Medical Center of PLA General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026