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NCT Number: NCT04441151

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLAGH Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

wang kai fei Wang, doctor

CONTACT

[email protected]

+861055499330

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary rehabilitation therapy

Behavioral

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.

Primary outcomes

  1. MRC

    Time frame: Day 28

    Medical Research Council,Muscle strength assessment,total points0~60,less than 48scores means ICU aquired weaknesses.

  2. STS

    Time frame: Day 28

    Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.

  3. barthel index

    Time frame: Day 28

    barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100,less than 60 scores means can't independent living.

  4. Borg dyspnea score

    Time frame: Day 28

    Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe

  5. PaO2

    Time frame: Day 28

    arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.

  6. Oxygenation index

    Time frame: Day 28

    arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.

  7. Diaphragm mobility

    Time frame: Day 28

    The distance the diaphragm drops during inhalation,normal is 1.4cm.

  8. Diaphragm contraction velocity

    Time frame: Day 28

    The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.

  9. End-inspiratory diaphragm thickness

    Time frame: Day 28

    The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.

  10. End-expiratory diaphragm thickness

    Time frame: Day 28

    The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.

  11. Diaphragm thickness variation rate

    Time frame: Day 28

    Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.

Secondary outcomes

  1. ICU stay time

    Time frame: 3 month

    icu length of stay

  2. Hospitalization time

    Time frame: Month 3

    Hospitalization time,length of stay in hospital.

  3. The time it takes to get out of bed for the first time

    Time frame: Day 28

    The time it takes to get out of bed for the first time

  4. Use of non-invasive ventilator

    Time frame: Day 28

    Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.

  5. Intubation

    Time frame: Day 28

    Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days

  6. mortality

    Time frame: Day 28

    mortality

  7. Complication

    Time frame: Day 28

    The incidence of new complications(pressure sores、thrombus、aspiration).

Study contacts

Contact information is provided by the study sponsor or research team.

kai fei Wang

CONTACT

[email protected]

+861055499330 ext. 17600953801

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2020
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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