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Completed

NCT Number: NCT05295381

Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

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.

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Key information

Conditions

PMV

Age range

57 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Medical Foundation

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 (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.

Primary outcomes

  1. Maximum inspiratory pressure change by the intervention

    Time frame: Change between 1 day before and 2 weeks after the intervention

    lung function

  2. Maximum expiratory pressure change by the intervention

    Time frame: Change between 1 day before and 2 weeks after the intervention

    lung function

Secondary outcomes

  1. vital capacity change by the intervention

    Time frame: Change between 1 day before and 2 weeks after the intervention

    lung function

Sponsors and collaborators

Lead sponsor

Liu Shih Feng

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 25, 2022
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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