Effectness of Treatment With Mechanical Insufflation-Exsufflation

NCT04149873 | Completed

• 1 other identifier: CMFHR 10460(IRB10407-008)
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Mortality

Outcome Measures

Primary Outcomes (1)

• mortality rate

  One year mortality rate

  1 year

Study Arms (3)

Control group

PLACEBO COMPARATOR

Control group' has the treatment with \[Physical chest care \]

Procedure: MIE

Experimental group-A

PLACEBO COMPARATOR

'Experimental group-A' has the treatment with \[Mechanical-Insufflation- Exsufflation\]

Procedure: MIE

Experimental group-B

EXPERIMENTAL

'Experimental group-B' has the treatment with \[Mechanical-Insufflation- Exsufflation\] and \[Physical chest care\]

Procedure: MIE

Interventions

MIE PROCEDURE

MIE

Control group; Experimental group-A; Experimental group-B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written Informed Consent given by the patient or, if not possible, by a legally authorized representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
• To be at least 20 years of age.
• To be treated in an ICU at the time of enrollment.
• Endotracheal tube in place
• The patient is mechanically ventilated and reach:
• Ventialtopr: Pressure support mode
• reach 6-8CC/IBW, ideal body weight for 24 hours
• MEP, maximum expiratory pressure \< 60cmH2O

You may not qualify if:

• The patient or legally authorized representative refuse
• \< 20 years of age.
• Neither endotracheal tube nor mechanical ventilator use
• The patient is mechanically ventilated, but:
• The ventialtopr mode NOT: Pressure support mode
• No reach 6-8CC/IBW, ideal body weight for 24 hours
• MEP, maximum expiratory pressure \> 60cmH2O
• Participation as subject in another interventional study within 30 days prior to the first dose of study treatment, or planned participation in such a study during the study or within 30 days of its completion by the patient.

Sponsors & Collaborators

• Chimei Medical Center: lead

Study Sites (1)

Department of Intensive Care Medicine; Chi Mei Medical Center

Tainan, 710, Taiwan

Location

Study Officials

• Kuo-Chen Cheng, Chief

  Chi Mei Medical Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: November 4, 2019
• Study Start: September 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)