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Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

L

Liu Shih Feng

Status

Completed

Conditions

PMV

Treatments

Device: abdominal weight training (AWT)
Device: cough machine (CM)

Study type

Interventional

Funder types

Other

Identifiers

NCT05295381
201900885B0A3

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

57 to 84 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 3 patient groups

abdominal weight training with cough machine (CM)
Experimental group
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.
Treatment:
Device: abdominal weight training (AWT)
Device: cough machine (CM)
abdominal weight training (AWT) without cough machine (CM)
Experimental group
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.
Treatment:
Device: abdominal weight training (AWT)
control
No Intervention group
Description:
no abdominal weight training and no cough machine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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