Inspiratory Muscle Training in Mechanically Ventilated Patients in Intensive Care Unit

NCT ID: NCT06609564

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-02-02

Brief Summary

In addition to conventional chest physiotherapy, inspiratory muscle training will be applied in mechanically ventilated intensive care patients. It is aimed to examine the effects of inspiratory muscle training on respiratory muscle strength, diaphragm thickness, and diaphragm excursion in intubated or tracheostomized patients with mechanical ventilation in the intensive care unit.

Detailed Description

Subjects who mechanically ventilated in the intensive care unit will be divided two groups. Study group will recieve inspiratory muscle training in addition to convantional chest physiotherapy. Control group will recieve convantional chest physiotherapy. Training will continue until discharge or until the 21st day of the training. Respiratory muscle strength, diaphragm thickness and diaphragm excursion were measured before training and before discharge.

Conditions

Intensive Care Patients Invasively Ventilated; Mechanical Ventilation; Inspiratory Muscle Training; Diaphragm Ultrasonography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Inspiratory Muscle Training

Inspiratory muscle training in addition to convantional chest physiotherapy

Group Type: EXPERIMENTAL

inspiratory muscle training

Intervention Type: DEVICE

Inspiratory muscle training with a pressure-adjustable device

Convational Chest Physiotherapy

Diaphragm breathing, costal expansion exercises, postural drainage, effective coughing, in-bed range of motion exercises, and mobilization

Group Type: EXPERIMENTAL

Convantional chest physiotherapy

Intervention Type: OTHER

Chest physiotherapy

Interventions

inspiratory muscle training

Inspiratory muscle training with a pressure-adjustable device

Intervention Type: DEVICE

Convantional chest physiotherapy

Chest physiotherapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥18 years of age
• hemodynamic stability and alert
• able to spontaneously trigger the ventilator and perform at least one command for activation of respiratory muscles
• required mechanical ventilation support with continuous spontaneous ventilation mode or pressure- or volume-controlled intermittent mandatory ventilation (6 breaths/min) mode
• required pressure support ≤ 15 cmH2O and PEEP ≤ 10 cmH2O
• unable to breathe without support for 72 consecutive hours following the resolution of factors leading to respiratory failure
• FiO2 of 0.5 or less
• PaO2 greater than 60 mmHg and capable of sufficient gas exchange

Exclusion Criteria

• cooperation disorder
• trauma or deformity related to the thorax that affect respiration
• progressive neuromuscular disease
• excessive bronchial secretion (requiring more than one suctioning per hour)
• need for continued sedative or analgesic agents
• use of home-type mechanical ventilation before admission to the hospital
• cardiac, pulmonary, or other conditions leading to impaired stability
• impaired cooperation, compliance, and motivation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: collaborator

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Harun Taşkın

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

60116787-020/55139

Identifier Type: -

Identifier Source: org_study_id