Inspiratory Muscle Training in Mechanically Ventilated Patients in Intensive Care Unit

Effects of Inspiratory Muscle Training on Respiratory Muscle Strength, Diaphragm Thickness, and Diaphragm Excursion in Mechanically Ventilated Intensive Care Patients

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation; Inspiratory Muscle Training; Intensive Care Patients Invasively Ventilated; Diaphragm Ultrasonography
• Intervention / Treatment: Device: inspiratory muscle training; Other: Convantional chest physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory Muscle Training; Inspiratory muscle training in addition to convantional chest physiotherapy	Device: inspiratory muscle training; Inspiratory muscle training with a pressure-adjustable device
Experimental: Convational Chest Physiotherapy; Diaphragm breathing, costal expansion exercises, postural drainage, effective coughing, in-bed range of motion exercises, and mobilization	Other: Convantional chest physiotherapy; Chest physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function in Intensive Care Test (PFIT)	The PFIT is a test battery applied by the researchers that consists of four main headings: "Support (from sitting to standing up)," "Cadence (steps/minute)," "Shoulder (flexion strength)," and "Knee (extension strength)." Stand up from sitting was scored according to the degree of help received (0 = without help, 1 = with the help of one person, 2 = with the help of two people). We recorded standstill as the number of steps and the time elapsed while the standing still action was performed. Shoulder and knee muscle strength were assessed using a manual muscle test (0 = no contraction, 1 = contraction only, 2 = movement completed when gravity is eliminated, 3 = movement completed against gravity, 4 = movement completed with less than maximum resistance to gravity, 5 = movement completed with maximum resistance to gravity)	20 minutes
Duration of intubation	After the subjects were included in the study duration of intubation was recorded.	3-15 days
Extubation rate	Weaning rates of patients from mechanical ventilation	3-15 days
Rate of discharge from the intensive care unit	Discharge rate of patients included in the study from intensive care unit	8-21 days

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University
• Collaborators: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): February 2, 2020
• Study Completion (Actual): February 2, 2020

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Mechanical Ventilation; Inspiratory Muscle Training; Physiotherapy and Rehabilitation; Ultrasound of Diaphragm
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 60116787-020/55139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No