Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

NCT05295381 | Completed DMC

• 1 other identifier: 201900885B0A3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

PMV

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• vital capacity change by the intervention

  Change between 1 day before and 2 weeks after the intervention

Study Arms (3)

abdominal weight training with cough machine (CM)

EXPERIMENTAL

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); Device: abdominal weight training (AWT)

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

EXPERIMENTAL

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)

control

NO INTERVENTION

no abdominal weight training and no cough machine

Interventions

cough machine (CM) DEVICE

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 training with cough machine (CM)

abdominal weight training (AWT) DEVICE

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.

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

Eligibility Criteria

• Age: 57 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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)

Sponsors & Collaborators

• Liu Shih Feng: lead

Study Sites (1)

Chang Gung Medical Foundation

Taipei, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 27593879 RESULT

• 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.

  PMID: 25171575 RESULT

• 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.

  PMID: 11359958 RESULT

• 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.

  PMID: 35614518 DERIVED

Study Officials

• Tsang-Tang Hsieh

  Institutional Review Board Chang Gung Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of department of respiratory therapy in Kaohsiung CGMH

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

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 25, 2022
• Study Start: August 21, 2019
• Primary Completion: August 13, 2020
• Study Completion: August 13, 2020
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)