Status:

COMPLETED

Comparison of the Effects of Inspiratory Muscle Training Methods in Mechanically Ventilated Patients

Lead Sponsor:

Saglik Bilimleri Universitesi

Collaborating Sponsors:

Goztepe Prof Dr Suleyman Yalcın City Hospital

SB Goztepe Prof Suleyman Yalcin City Hospital

Conditions:

Mechanical Ventilation

Intensive Care Units

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

Inspiratory Muscle Training(IMT) increases the strength and endurance of the inspiratory muscles, exercise capacity, quality of life and reduces the perception of dyspnea. It has been reported in the ...

Detailed Description

The intensive care unit (ICU) is the unit where patients with acute and life-threatening organ dysfunction or at risk are treated. Various technologies are used to support organ systems, especially th...

Eligibility Criteria

Inclusion

  • ≥18 years of age,
  • Hemodynamically stable,
  • Alert and conscious(Between -2 and +2 according to Richmond Agitation and Sedation Scale score)
  • Perform at least one motor command,
  • Requiring mechanical ventilation support either with continuous spontaneous ventilation(CPAP) mode or intermittent mandatory ventilation(SIMV) mode with pressure or volume control(PSV),
  • Requiring oxygen ventilation ≤ 40%, Required pressure support ≤ 15 cmH2O, and PEEP ≤ 10 cmH2O,
  • Having a body temperature between 36- 38 °C,
  • Unable to breathe unsupported for 72 consecutive hours following the resolution of factors supporting respiratory failure,
  • Having FiO2 ≤ 0.5, PaO2 \> 60 mmHg, and capable of sufficient gas exchange,
  • Patients deemed suitable for pulmonary physiotherapy by intensive care physicians will be included in the study.

Exclusion

  • Having an acute onset of illness,
  • Impaired cooperation,
  • Insufficient level of consciousness due to severe intracranial disease ,
  • Having a progressive neuromuscular disease,
  • Having an unstable neurological condition,
  • Having a psychiatric disorder and exhibiting excessive agitation (patients with Richmond Agitation and Sedation Scale (RASS) ≥ +2),
  • Having experienced any trauma to the chest wall,
  • Having thoracic deformities that affect respiration,
  • Using a high amount of sedative or analgesic agents,
  • Participants using home mechanical ventilators prior to hospital admission.
  • Criteria for Study Discontinuation:
  • Cardiac, pulmonary, and other conditions leading to impaired hemodynamic stability.
  • Impaired cooperation, compliance, and motivation.
  • Discontinuation by the intensive care physician.
  • Participants will be free to withdraw from the study at their discretion.

Key Trial Info

Start Date :

November 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 15 2024

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT06046690

Start Date

November 1 2023

End Date

November 15 2024

Last Update

January 23 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Health Sciences

Istanbul, Turkey (Türkiye), 34353

Comparison of the Effects of Inspiratory Muscle Training Methods in Mechanically Ventilated Patients | DecenTrialz