The Impact of Inspiratory Muscle Strength Training

NCT03997214 | Completed DMC

• 1 other identifier: 108001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a pre-post test with quasi experimental design. Forty-two intubated-adults who had been mechanically ventilated for more than 21 days were selected on the basis of inclusion criteria in respiratory care ward. These patients were classified equally into study group and control group. The experimental group received the intervention of respiratory muscles training 5 times/ a week for 6 weeks. The control group received normal care. The intervention was adjusted trigger sensitivity to 10% of the first recorded Maximal Inspiratory Pressure at the start of training, then increased the ventilator trigger sensitivity and training duration weekly. The largest of ventilator trigger sensitivity is not over 40% of the initial Maximal Inspiratory Pressure and the timing of training duration is no longer than 30 minutes.

Conditions

Ventilator Dependency

Outcome Measures

Primary Outcomes (5)

• Maximal inspiratory pressure

  a measure of the strength of inspiratory muscles, measurement by cmH2O.

  7 weeks

• Tidal volume

  the volume of air that is transported into and out of the lungs with each respiratory cycle, measurement by mL per inspiration

  7 weeks

• Minute ventilation volume

  the quantity of air moved into and out of the lungs in a minute, measurement by l.min

  7 weeks

• Rapid shallow breathing index

  the ratio of respiratory frequency to tidal volume (f/VT)

  7 weeks

• Oxygenation index.

  Oxygenation index OI = FiO2 x 100 x M AP/PaO2, where FiO2 is the fraction of inspired oxygen, MAP is the mean airway pressure, and PaO2 is the partial pressure of oxygen in arterial blood, calculated at the end of the first day of standardized preoperative stabilization

  7 weeks

Study Arms (2)

Control group

NO INTERVENTION

as usual care

experimental group

EXPERIMENTAL

The intervention of inspiratory muscle strength training

Device: inspiratory muscle strength training

Interventions

inspiratory muscle strength training DEVICE

The experimental group received the intervention of inspiratory muscles training 5times/week for 6 weeks, 5days/ per cycle; the patients stayed in the semi-recumbent position, recorded the initial/first measurement of MIP. The trigger sensitivity was adjusted to 10% of the first recorded MIP at the start of training, then reducing the ventilator trigger sensitivity and training duration weekly.

experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>20y/o
• Vital signs stable
• MIP \<20cmH2O
• Ventilator FiO2\<40%, PEEP \<8
• Ventilator mode:PSV or SIMV

You may not qualify if:

• Patient or family refuse

Sponsors & Collaborators

• Fooyin University: lead

Study Sites (1)

Shinghou Hospital

Kaohsiung City, Fengshan, 830, Taiwan

Location

Study Officials

• Hsiao-Yun Chang, Ph.D

  Fooyin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 25, 2019
• Study Start: June 15, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 31, 2018
• Last Updated: June 25, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)