Inspiratory Muscle Training in Mechanically Ventilated Patients in Intensive Care Unit

Not Applicable

Completed

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

• Registration Number: NCT06609564
• Lead Sponsor: Afyonkarahisar Health Sciences University

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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2020-02-02
• Study Completion: 2020-02-02
• Status Verified: 2024-09
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory muscle strengh	20 minutes	Respiratory muscle strength was measured as maximal inspiratory pressure.
Diaphragm thickness	15 minutes	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).
Diaphragm excursion	20	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.

Secondary Outcome Measures

Name	Time	Method
Physical Function in Intensive Care Test (PFIT)	20 minutes	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)
Rate of discharge from the intensive care unit	8-21 days	Discharge rate of patients included in the study from intensive care unit
Duration of intubation	3-15 days	After the subjects were included in the study duration of intubation was recorded.
Extubation rate	3-15 days	Weaning rates of patients from mechanical ventilation

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey