Effect of Adding PNF to IMT on Weaning Off MV

Официальное название

Effect of Adding Proprioceptive Neuromuscular Facilitation to Inspiratory Muscle Training on Weaning Off Mechanical Ventilation

Обзор

the goal of this clinical trial is to find out the effect of adding proprioceptive neuromuscular facilitation to inspiratory muscle training on weaning off mechanical ventilation. the main question it aims to answer is is there a significant difference in the effect of inspiratory muscle training combined with PNF on the duration of weaning in the mechanically ventilated ICU patients. researchers will compare effect of (Inspiratory muscle training combined with PNF) to (Inspiratory muscle training) and control group. participants will be mechanically ventilated both sexes patients will be recruited in this study from intensive care unit, their ages older than 18 years. The selected patients will be mechanically ventilated due to respiratory failure and will randomly assigned into three equal groups.

Подробное описание

type of study: randomized control trial this study is a prospective interventional study one that will be conducted on ninety three mechanically ventilated patients with respiratory failure of both sexes their ages older than 18 years from intensive care unit and will randomly assigned into three equal groups:

1. intervention group 1:include 31 mechanically ventilated patients will receive inspiratory muscle training along with Conventional rehabilitation program plus medical treatment. 2. intervention group 2: include 31 mechanically ventilated patients will receive inspiratory muscle training combined with proprioceptive neuromuscular facilitation along with Conventional rehabilitation program plus medical treatment. 3. Control group: include 31 mechanically ventilated patients will receive Conventional rehabilitation program plus medical treatment.

Instrumentations:

A) Evaluation:

All the following will be measured for all patients who will participate in this study

1. ICU length of stay. 2. Monitoring:

* Mode of ventilation parameters.

* Fiao2 * PEEP * Tidal Volume * Respiratory Rate * The Duration and Type of Weaning:

* Simple * Prolonged * Difficult * The patient vital signs:

* Heart rate * Respiratory rate * Oxygen saturation 3. Maximum inspiratory pressure 4. Laboratory investigation:

\- Arterial Blood Gases (ABG): for measurement of Pao2, Partial pressure of CO2 (Paco2), Hco3 and PH 5. Sonar parameters:

\- Diaphragmatic excursion. 6. APHACH II score 7. Shallow breathing index. 8. Lung compliance: - Static and dynamic

Вмешательства

• Устройство threshold inspiratory muscle training + conventional chest physiotherapy
  threshold inspiratory muscle training: threshold inspiratory muscle training in addition to conventional chest physiotherapy. The TIMT device will be connected to an endotracheal tube and will be verified to be reliable for inspiratory muscle training. With patient in 45 supine position, he will instructed to exhale slowly, empty the air in the lungs and then inhale deeply and vigorously as fast as possible. The MIP will recorded. The inspiratory resistance is set at 50% of MIP. When the heart r
• Устройство proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy
  PNF training: in the form of rhythmic initiation technique (RIT) and initial stretch technique (IST) in addition to TIMT plus Conventional Chest Physiotherapy. The RIT performed to teach coordination of motion and to establish the correct breathing pattern. The IST applied to reinforce the strength of inspiratory muscles. Its main aim is to facilitate the initiation of motion . PNF techniques include two sessions per day, 5 days/week until patients are weaned from mechanical ventilation. Includi
• Другое Conventional Chest Physiotherapy
  Conventional Chest Physiotherapy only: two sessions per day, 5 days/week which included Vibration, Percussion, hyperinflation, and suctioning if indicated until patients are weaned from mechanical ventilation.

Первичные конечные точки

• • Time to Successful weaning [Срок оценки: From enrollment to the end of treatment (an average of 7 to 14 days)]
• • Maximum inspiratory pressure [Срок оценки: From enrollment to the end of treatment (an average of 7 to 14 days)]
• • Diaphragmatic excursion [Срок оценки: From enrollment to the end of treatment (an average of 7 to 14 days)]

Вторичные конечные точки (3)

• • ICU length of stay [Срок оценки: From enrollment to the end of treatment (an average of 7 to 14 days)]
• Lung compliance [Срок оценки: From enrollment to the end of treatment (an average of 7 to 14 days)]
• Classification of patients according to the weaning process [Срок оценки: From enrollment to the end of treatment (an average of 7 to 14 days)]

Критерии участия

Критерии включения

• Adults of both sexes
• patients older than 18 years
• Conscious and cooperative
• Hemodynamic stability without significant vasopressor support.
• No continuous sedation.
• Mechanically ventilated due to type 1 or type 2 respiratory failure (RF) for at least 24 hours.
• Mechanically ventilated in assisted ventilation mode
• Are able to participate in training actively, weanable as regard shallow breathing index.
• presence of weaning criteria as defined in the European Consensus Conference in 2007, including sedation reduction, spontaneous breathing cycles, Partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FiO2) ≥ 150, absence of inotropes or vasopressors at high doses or increasing doses (< 1 mg/h), oxy-hemoglobin saturation (SaO2) > 90% with FiO2≤ 50%, positive end expiratory pressure (PEEP) ≤ 8 cmH2O, temperature between 36 and 39 °C.

Критерии исключения

• Hemodynamic or respiratory instability
• Condition that can compromise weaning, such as heart failure.
• Condition that can prevent adequate performance of inspiratory muscle training, such as neuropathy or myopathy.
• Thoracic or abdominal surgery precluding the use of PNF exercises
• Rib fractures
• Current pregnancy
• Cardiac arrest with a guarded neurological prognosis
• Deep coma

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07536347 · FPTBSUREC/0101/201024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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