Clinical trial NCT05295381: 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
Overall status: COMPLETED
Phase: NA
Conditions: PMV
Keywords: prolonged mechanical ventilation
weaning ventilator
abdominal weight training
cough machine
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 57
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AWT group (n=12), AWT+CM group (n=14) control group (n=14).
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Maximum inspiratory pressure change by the intervention
timeFrame: Change between 1 day before and 2 weeks after the intervention
measure: Maximum expiratory pressure change by the intervention
timeFrame: Change between 1 day before and 2 weeks after the intervention
Secondary outcomes:
measure: vital capacity change by the intervention
timeFrame: Change between 1 day before and 2 weeks after the intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Medical Foundation
Study officials:
affiliation: Institutional Review Board Chang Gung Medical Foundation
name: Tsang-Tang Hsieh
role: STUDY_CHAIR
References:
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.
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.
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.
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.