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Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

Primary Purpose

PMV

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

cough machine (CM)

abdominal weight training (AWT)

About this trial

This is an interventional treatment trial for PMV focused on measuring prolonged mechanical ventilation, weaning ventilator, abdominal weight training, cough machine

Eligibility Criteria

57 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(1) Invasive ventilator users,
(2) Hemodynamically stable,
(3) Intubated endotracheal tube or tracheotomy tube,
(4) Clearly conscious and cooperative,
(5) Vital capacity (VC) <10ml/kg

Exclusion Criteria:

(1) Unconscious or unwilling to sign the informed consent form,
(2) No spontaneous breathing,
(3) Active bleeding with unstable hemodynamics,
(4) Acute infection symptoms,
(5) Abdominal distension, digestion problems (including nausea and vomiting),
(6) Severe heart failure (ejection fraction ≤ 30%),
(7) Unhealed wounds in the chest and abdomen,
(8) Bullous emphysema,
(9) Sensitive pneumothorax or mediastinal pneumothorax,
(10) Recent history of traumatic stress,
(11) Acute head and neck injury (unless the injury site is immobilized)

Sites / Locations

Chang Gung Medical Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

abdominal weight training with cough machine (CM)

abdominal weight training (AWT) without cough machine (CM)

control

Arm Description

abdominal weight exercise training (sandbag) is maintained for 30 minutes; the starting weight is 1kg to 2kg, and the previous day's weight is maintained each day as well as adding 0.5kg daily. Cough machine training is based on the cough assist machine Comfort Cough II (CC20), in which the inhalation and exhalation times are adjusted to 1-3 seconds, and the positive and negative pressure of the lower pressure 10-15 cmH2O is gradually increased to 30-40 cmH2O for the first time, 4-6 cycles/time, repeated 4-6 times, twice a day, five days a week, until the subject is weaned off the ventilator or transferred out of the ward. A modified Borg scale was used as an indicator of perceived dyspnea.

abdominal weight exercise training (sandbag) is maintained for 30 minutes; the starting weight is 1kg to 2kg, and the previous day's weight is maintained each day as well as adding 0.5kg daily.

no abdominal weight training and no cough machine

Outcomes

Primary Outcome Measures

Maximum inspiratory pressure change by the intervention

lung function

Maximum expiratory pressure change by the intervention

lung function

Secondary Outcome Measures

vital capacity change by the intervention

lung function

Full Information

NCT ID

NCT05295381

First Posted

February 18, 2022

Last Updated

March 24, 2022

Sponsor

Liu Shih Feng

1. Study Identification

Unique Protocol Identification Number

NCT05295381

Brief Title

Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

Official Title

Effect of Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function in the Patients With Prolonged Mechanical Ventilation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

August 21, 2019 (Actual)

Primary Completion Date

August 13, 2020 (Actual)

Study Completion Date

August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Liu Shih Feng

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The patients with prolonged mechanical ventilation (PMV) have the risk of ineffective coughing and infection due to diaphragm weakness, making it more difficult to wean. This study aimed to explore the intervention of abdominal weight training (AWT) with/ without cough machine (CM) on lung function, respiratory muscle strength and cough ability in these patients.

Detailed Description

Methods 40 patients with PMV were randomly assigned to three groups: AWT group (n=12), AWT+CM group (n=14) and control group (n=14). The effectiveness on pulmonary function, respiratory muscle strength and cough ability were compared among these three groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PMV

Keywords

prolonged mechanical ventilation, weaning ventilator, abdominal weight training, cough machine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

AWT group (n=12), AWT+CM group (n=14) control group (n=14).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

abdominal weight training with cough machine (CM)

Arm Type

Experimental

Arm Description

Arm Title

abdominal weight training (AWT) without cough machine (CM)

Arm Type

Experimental

Arm Description

abdominal weight exercise training (sandbag) is maintained for 30 minutes; the starting weight is 1kg to 2kg, and the previous day's weight is maintained each day as well as adding 0.5kg daily.

Arm Title

control

Arm Type

No Intervention

Arm Description

no abdominal weight training and no cough machine

Intervention Type

Device

Intervention Name(s)

cough machine (CM)

Intervention Description

Cough machine training is based on the cough assist machine Comfort Cough II (CC20), in which the inhalation and exhalation times are adjusted to 1-3 seconds, and the positive and negative pressure of the lower pressure 10-15 cmH2O is gradually increased to 30-40 cmH2O for the first time, 4-6 cycles/time, repeated 4-6 times, twice a day, five days a week, until the subject is weaned off the ventilator or transferred out of the ward. A modified Borg scale was used as an indicator of perceived dyspnea.

Intervention Type

Device

Intervention Name(s)

abdominal weight training (AWT)

Intervention Description

abdominal weight exercise training (sandbag) is maintained for 30 minutes; the starting weight is 1kg to 2kg, and the previous day's weight is maintained each day as well as adding 0.5kg daily.

Primary Outcome Measure Information:

Title

Maximum inspiratory pressure change by the intervention

Description

lung function

Time Frame

Change between 1 day before and 2 weeks after the intervention

Title

Maximum expiratory pressure change by the intervention

Description

lung function

Time Frame

Change between 1 day before and 2 weeks after the intervention

Secondary Outcome Measure Information:

Title

vital capacity change by the intervention

Description

lung function

Time Frame

Change between 1 day before and 2 weeks after the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

57 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (1) Invasive ventilator users, (2) Hemodynamically stable, (3) Intubated endotracheal tube or tracheotomy tube, (4) Clearly conscious and cooperative, (5) Vital capacity (VC) <10ml/kg Exclusion Criteria: (1) Unconscious or unwilling to sign the informed consent form, (2) No spontaneous breathing, (3) Active bleeding with unstable hemodynamics, (4) Acute infection symptoms, (5) Abdominal distension, digestion problems (including nausea and vomiting), (6) Severe heart failure (ejection fraction ≤ 30%), (7) Unhealed wounds in the chest and abdomen, (8) Bullous emphysema, (9) Sensitive pneumothorax or mediastinal pneumothorax, (10) Recent history of traumatic stress, (11) Acute head and neck injury (unless the injury site is immobilized)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tsang-Tang Hsieh

Organizational Affiliation

Institutional Review Board Chang Gung Medical Foundation

Official's Role

Study Chair

Facility Information:

Facility Name

Chang Gung Medical Foundation

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27593879

Citation

Kim SM, Choi WA, Won YH, Kang SW. A Comparison of Cough Assistance Techniques in Patients with Respiratory Muscle Weakness. Yonsei Med J. 2016 Nov;57(6):1488-93. doi: 10.3349/ymj.2016.57.6.1488.

Results Reference

result

PubMed Identifier

25171575

Citation

Lacombe M, Del Amo Castrillo L, Bore A, Chapeau D, Horvat E, Vaugier I, Lejaille M, Orlikowski D, Prigent H, Lofaso F. Comparison of three cough-augmentation techniques in neuromuscular patients: mechanical insufflation combined with manually assisted cough, insufflation-exsufflation alone and insufflation-exsufflation combined with manually assisted cough. Respiration. 2014;88(3):215-22. doi: 10.1159/000364911. Epub 2014 Aug 21.

Results Reference

result

PubMed Identifier

11359958

Citation

Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44. doi: 10.1136/thorax.56.6.438.

Results Reference

result

PubMed Identifier

35614518

Citation

Hung TY, Wu WL, Kuo HC, Liu SF, Chang CL, Chang HC, Tsai YC, Liu JF. Effect of abdominal weight training with and without cough machine assistance on lung function in the patients with prolonged mechanical ventilation: a randomized trial. Crit Care. 2022 May 25;26(1):153. doi: 10.1186/s13054-022-04012-1.

Results Reference

derived

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Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

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