Inspiratory Muscle Training in Mechanically Ventilated Patients in Intensive Care Unit

NCT06609564 | Completed

• 1 other identifier: 60116787-020/55139
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Physiotherapy and Rehabilitation; Inspiratory Muscle Training; Ultrasound of Diaphragm; Intensive Care Unit; Mechanical Ventilation

Outcome Measures

Primary Outcomes (3)

• Respiratory muscle strengh

  Respiratory muscle strength was measured as maximal inspiratory pressure.

  20 minutes

• Diaphragm thickness

  Diaphragm thickness was evaluated using ultrasound imaging in two-dimensional B mode (4-13 MHz) performed from the midaxillary level from the right intercostal space with patients sitting in a position as upright as possible. The thickness of the diaphragm was ensured with the superficial probe at end-inspiration (Tins) and end-expiration (Texp).

  15 minutes

• Diaphragm excursion

  Diaphragm excursion was evaluated at the midaxillary level from the right subcostal area with M-mode (2-5 MHz) ultrasonography in normal inspiration and deep inspiration.

  20

Secondary Outcomes (4)

• Physical Function in Intensive Care Test (PFIT)

  20 minutes

• Duration of intubation

  3-15 days

• Extubation rate

  3-15 days

• Rate of discharge from the intensive care unit

  8-21 days

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL

Inspiratory muscle training in addition to convantional chest physiotherapy

Device: inspiratory muscle training

Convational Chest Physiotherapy

EXPERIMENTAL

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

Other: Convantional chest physiotherapy

Interventions

inspiratory muscle training DEVICE

Inspiratory muscle training with a pressure-adjustable device

Inspiratory Muscle Training

Convantional chest physiotherapy OTHER

Chest physiotherapy

Convational Chest Physiotherapy

Eligibility Criteria

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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead
• Pamukkale University: collaborator

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 24, 2024
• Study Start: September 1, 2017
• Primary Completion: February 2, 2020
• Study Completion: February 2, 2020
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)