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

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease
• Intervention / Treatment: Behavioral: Pulmonary rehabilitation 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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhao Ying; Phone Number: 17600953801 17600953801; Email: 1412888703@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Pulmonary rehabilitation therapy	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.
No Intervention: Control group; Routine medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRC	Medical Research Council,Muscle strength assessment,total points0~60，less than 48scores means ICU aquired weaknesses.	Day 28
STS	Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.	Day 28
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
Borg dyspnea score	Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe	Day 28
PaO2	arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.	Day 28
Oxygenation index	arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.	Day 28
Diaphragm mobility	The distance the diaphragm drops during inhalation,normal is 1.4cm.	Day 28
Diaphragm contraction velocity	The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.	Day 28
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
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
Diaphragm thickness variation rate	Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU stay time	icu length of stay	3 month
Hospitalization time	Hospitalization time,length of stay in hospital.	Month 3
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
Use of non-invasive ventilator	Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.	Day 28
Intubation	Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days	Day 28
mortality	mortality	Day 28
Complication	The incidence of new complications(pressure sores、thrombus、aspiration).	Day 28

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Zhao Ying, The First Medical Center of PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: Pulmonary rehabilitation (Home-based pulmonary rehabilitation in COPD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No