Effects of Respiratory Rehabilitation on ICU Patients

Rehabilitation Clinical Trial

Official title:

Effects of Respiratory Rehabilitation on Patients After Extubation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04368286
• Other study ID #: S2018-212-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2020
• Est. completion date: April 20, 2021

Study information

• Verified date: December 2020
• Source: Chinese PLA General Hospital
• Contact: ying zhao
• Phone: +86 17600953801
• Email: 1412888703[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effects of respiratory rehabilitation on patients after extubation

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• ICU Acquired Weakness
• Rehabilitation

Intervention

Behavioral:
• pulmonary 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

References & Publications (1)

Hernández G, Vaquero C, Colinas L, Cuena R, González P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernández R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194. Erratum in: JAMA. 2016 Nov 15;316(19):2047-2048. Erratum in: JAMA. 2017 Feb 28;317(8):858. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintubation rates	The artificial airway was established again for invasive mechanical ventilation	28 days
Secondary	MRC,medical research council	medical research council,Assessment of peripheral muscle strength,total points0~60,less than 48scores means ICU aquired weaknesses.	28 days
Secondary	30-STS	30 second sit-to-stand test.The more times, has the better muscular endurance.	28 days
Secondary	Barthel	Assessment of activities of daily living.total points0~100,less than 60 scores means can't independent living.	28 days
Secondary	Borg dyspnea score	total points0~10,The higher the grade, the more difficulty breathing.	28 days
Secondary	oxygen partial pressure	Partial pressure of oxygen in arterial blood,normal range is 80~100.	28 days
Secondary	oxygenation index	The partial pressure of oxygen divided by the concentration of oxygen,Normal is greater than 400.	28 days
Secondary	The diaphragmatic excursion	The distance the diaphragm moves up and down during breathing,normal is 1.4cm.	28 days
Secondary	diaphragm contraction rate	The rate at which the diaphragm contracts during breathing,normal is 1.3cm/s.	28 days
Secondary	diaphragm thickness diaphragm thickness fraction	Thickness 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	28 days
Secondary	length of stay in ICU	Length of stay in ICU	three months
Secondary	LOS(length of stay)	length of stay in hospital	three months
Secondary	First time out of bed	First time out of bed by oneself	three months
Secondary	Noninvasive utilization rate	Non-invasive ventilator usage	28 days
Secondary	mortality	Alive or Dead	28 days
Secondary	Complication rate	The incidence of new complications(pressure sores?thrombus?aspiration)	28 days