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

Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04441151
• Other study ID #: pulmonary rehabilitation
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2020
• Source: Chinese PLA General Hospital
• Contact: Zhao Ying
• Phone: 17600953801
• Email: 1412888703[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Behavioral:
• Pulmonary rehabilitation therapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRC	Medical Research Council,Muscle strength assessment,total points0~60,less than 48scores means ICU aquired weaknesses.	Day 28
Primary	STS	Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.	Day 28
Primary	barthel index	barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100,less than 60 scores means can't independent living.	Day 28
Primary	Borg dyspnea score	Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe	Day 28
Primary	PaO2	arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.	Day 28
Primary	Oxygenation index	arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.	Day 28
Primary	Diaphragm mobility	The distance the diaphragm drops during inhalation,normal is 1.4cm.	Day 28
Primary	Diaphragm contraction velocity	The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.	Day 28
Primary	End-inspiratory diaphragm thickness	The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.	Day 28
Primary	End-expiratory diaphragm thickness	The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.	Day 28
Primary	Diaphragm thickness variation rate	Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.	Day 28
Secondary	ICU stay time	icu length of stay	3 month
Secondary	Hospitalization time	Hospitalization time,length of stay in hospital.	Month 3
Secondary	The time it takes to get out of bed for the first time	The time it takes to get out of bed for the first time	Day 28
Secondary	Use of non-invasive ventilator	Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.	Day 28
Secondary	Intubation	Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days	Day 28
Secondary	mortality	mortality	Day 28
Secondary	Complication	The incidence of new complications(pressure sores?thrombus?aspiration).	Day 28