Effectness of Treatment With Mechanical Insufflation-Exsufflation

Not Applicable

Completed

• Conditions: Mortality
• Interventions: Procedure: MIE

• Registration Number: NCT04149873
• Lead Sponsor: Chimei Medical Center

Brief Summary

Patients defined with impaired cough function as maximum expiratory pressure (MEP) \< 60cmH2O. Collected the patients in our surgical ICU who are able to reach 6-8CC/IBW under pressure support mode for 24 hours and MEP \< 60cmH2O. Then the patients will be allocated to 3 groups to receive (1) conventional CPT (control group) (2) MI-E (study group A) (3) MI-E plus CPT (study group B) until 48 hours after extubation. Reintubation rates, ICU mortality and post-extubation ICU length of stay will be analyzed to evaluate its effects.

Detailed Description

Endotracheal intubation and mechanical ventilation are always used to treat acute respiratory failure in critically ill patients. Successful weaning from ventilator and extubation are crucial to determine the prognosis when patient's underlying disease getting improvement. The reasons for extubation failure include lack of improvement of on the work of breathing, hypoxemia, respiratory acidosis, conscious disturbance and retained respiratory secretions, etc. In our clinical practice, the factor of retained respiratory secretions plays an important role in successful extubation.

Traditional chest physiotherapy (CPT) is commonly used to help the critically patients in the effective expulsion of airway secretions. In recent years, new advanced techniques mechanical insufflations-exsufflation (MI-E) and high frequency chest wall oscillation (HFCWO)have been developed to get more effective to remove secretions for patients suffered from acute respiratory failure. The above devices have been described as an effective techniques for patients with chronic neuromuscular weakness, cystic fibrosis and bronchiectasis. By the knowledge, only one study mentioned about MI-E could reduce the reintubation rate and shorten the ICU length of stay. But its limitations include less of case number and not focusing on impaired cough function patients.

In this study, patients defined with impaired cough function as maximum expiratory pressure (MEP) \< 60cmH2O. Collected the patients in our surgical ICU who are able to reach 6-8CC/IBW under pressure support mode for 24 hours and MEP \< 60cmH2O. Then the patients will be allocated to 3 groups to receive (1) conventional CPT (control group) (2) MI-E (study group A) (3) MI-E plus CPT (study group B) until 48 hours after extubation. Reintubation rates, ICU mortality and post-extubation ICU length of stay will be analyzed to evaluate its effects.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Study First Submitted: 2018-01-24
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-31
• Last Update Submitted: 2019-10-31
• Study First Posted: 2019-11-04
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group-A	MIE	'Experimental group-A' has the treatment with \[Mechanical-Insufflation- Exsufflation\]
Experimental group-B	MIE	'Experimental group-B' has the treatment with \[Mechanical-Insufflation- Exsufflation\] and \[Physical chest care\]
Control group	MIE	Control group' has the treatment with \[Physical chest care \]

Primary Outcome Measures

Name	Time	Method
mortality rate	1 year	One year mortality rate

Trial Locations

Locations (1)

Department of Intensive Care Medicine; Chi Mei Medical Center; 🇨🇳 Tainan, Taiwan