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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06609564
Enrollment
24
Registered
2024-09-24
Start date
2017-09-01
Completion date
2020-02-02
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DEVICEinspiratory muscle training

Inspiratory muscle training with a pressure-adjustable device

OTHERConvantional chest physiotherapy

Chest physiotherapy

Sponsors

Pamukkale University
CollaboratorOTHER
Afyonkarahisar Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory muscle strengh20 minutesRespiratory muscle strength was measured as maximal inspiratory pressure.
Diaphragm thickness15 minutesDiaphragm 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 excursion20Diaphragm 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

MeasureTime frameDescription
Physical Function in Intensive Care Test (PFIT)20 minutesThe 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 unit8-21 daysDischarge rate of patients included in the study from intensive care unit
Duration of intubation3-15 daysAfter the subjects were included in the study duration of intubation was recorded.
Extubation rate3-15 daysWeaning rates of patients from mechanical ventilation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026