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NCT Number: NCT06609564

Inspiratory Muscle Training in Mechanically Ventilated Patients in Intensive Care Unit

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory muscle training

Device

Inspiratory muscle training with a pressure-adjustable device

Convantional chest physiotherapy

Other

Chest physiotherapy

Primary outcomes

  1. Respiratory muscle strengh

    Time frame: 20 minutes

    Respiratory muscle strength was measured as maximal inspiratory pressure.

  2. Diaphragm thickness

    Time frame: 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).

  3. Diaphragm excursion

    Time frame: 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 outcomes

  1. Physical Function in Intensive Care Test (PFIT)

    Time frame: 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)

  2. Duration of intubation

    Time frame: 3-15 days

    After the subjects were included in the study duration of intubation was recorded.

  3. Extubation rate

    Time frame: 3-15 days

    Weaning rates of patients from mechanical ventilation

  4. Rate of discharge from the intensive care unit

    Time frame: 8-21 days

    Discharge rate of patients included in the study from intensive care unit

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Collaborators

  • Pamukkale University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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