Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

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

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.

Study Overview

• Status: Completed
• Conditions: PMV
• Intervention / Treatment: Device: cough machine (CM); Device: abdominal weight training (AWT)

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Chang Gung Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 57 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: abdominal weight training with cough machine (CM); 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.	Device: cough machine (CM); 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.; Device: abdominal weight training (AWT); 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.
Experimental: abdominal weight training (AWT) without cough machine (CM); 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.	Device: abdominal weight training (AWT); 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 Intervention: control; no abdominal weight training and no cough machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum inspiratory pressure change by the intervention	lung function	Change between 1 day before and 2 weeks after the intervention
Maximum expiratory pressure change by the intervention	lung function	Change between 1 day before and 2 weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vital capacity change by the intervention	lung function	Change between 1 day before and 2 weeks after the intervention

Collaborators and Investigators

• Sponsor: Liu Shih Feng
• Investigators: Study Chair: Tsang-Tang Hsieh, Institutional Review Board Chang Gung Medical Foundation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Actual): August 13, 2020
• Study Completion (Actual): August 13, 2020

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: prolonged mechanical ventilation; weaning ventilator; abdominal weight training; cough machine
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 201900885B0A3

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