Clinical trial NCT06221033: Comparing the Effects of Manual Hyperinflation and Diaphragmatic Proprioceptive Neuromuscular Facilitation on Pulmonary Functions in Patients on Mechanical Ventilation
Official title: Manual Hyperinflation Versus Diaphragmatic Proprioceptive Neuromuscular Facilitation on Pulmonary Functions in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD Exacerbation Acute
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the goal of this clinical trial is to compare between to important physiotherapy modalities applied on mechanically ventilated COPD patients the the main question the study aim to answer is which one of the two modalities has the better effect on mechanically ventilated patients with COPD

patients will get manual hyperinflation technique and PNF technique \\

researchers will compare MHI with PNF and will take a control group also

Detailed description: In this study, the effects of diaphragmatic proprioceptive neuromuscular facilitation and manual hyperinflation on pulmonary functions in patients on mechanical ventilation will be compared.

The following headings will be used to present the study's subject and methods: patients, tools, study protocols, and statistical techniques.

I. Patients

The trial will involve sixty male patients with AECOPD who are on mechanical ventilation. They will be chosen from the Gamal Abdel Nasser Hospital's intensive care unit at the Health Insurance Organization in Alexandria, Egypt. They will be between the ages of fifty and sixty. Three equal groups will be randomly assigned to the study's patients.

Study Group A (20 patients) will undergo chest physiotherapy and conventional medical treatment in addition to manual hyperinflation technique.

Calculating the sample size:

Using G\*Power (version 3.1.9.2; Franz Faul, University at Kiel, Germany), the number of patients was determined. This study employed the t-test. Type II error was at 80% power, and type I error was 95% (alpha level: 0.05). The primary dependent variable, arterial blood gases, had an impact size of (Cohen's d) of 0.8. This figure was computed using data from the pilot trial on patients with AECOPD who were on mechanical ventilation. For the purposes of this investigation, sixty patients was the minimum.

Pre-post measures and a single-blinded, randomized controlled trial comprised the study's design. The study will be carried out in the Gamal Abdel Nasser Hospital's intensive care unit at the Health Insurance Organization in Alexandria, Egypt.

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

An event in the natural course of the disease known as an exacerbation of COPD is defined as a shift in the patient's baseline dyspnea, cough, and/or sputum that goes beyond daily fluctuation and necessitates a change in treatment.

Tests for pulmonary function (PEFs) A rapid, easy, non-invasive test that measures lung volume, capacity, flow rates, and gas exchange to demonstrate how effectively the lungs are functioning. Consequently, it offers the necessary information that your healthcare professional would need to diagnose and determine the course of treatment for specific lung problems.

manual hyperinflation A high tidal volume can be achieved by manual hyperinflation up to a peak pressure of 40 cmH2O. It begins with a sluggish inspiration, then moves into an inspiratory hold for two or three seconds before rapidly expiring (much like forced expiration). Using a manual hyperinflation bag with a positive end-expiratory pressure (PEEP) valve is one method that helps minimize derecruitment and atelectrauma by maintaining PEEP. Proprioceptive feedback from the bag to the operator is the benefit of manual hyperinflation over ventilator hyperinflation, whereas the safety of PEEP maintenance and the technique's uniformity and reproducibility are the benefits of ventilator hyperinflation. The manual hyperinflation technique is thought to be easier to utilize in awake patients than the ventilator hyperinflation maneuver.

Enhancing mobility of the chest wall can be accomplished by the facilitator technique known as proprioceptive neuromuscular facilitation. The most effective proprioceptive facilitator technique for returning to a normal breathing pattern is intercostal stretch. Other techniques include abdominal cocontraction, moderate manual pressure, perioral pressure, anterior stretch lift to the posterior basal area, and vertebral pressure to the upper and lower thoracic spines. PNF improves muscle strength, endurance, and mobility while facilitating control, stability, and coordinated movement, which sets the groundwork for function restoration.

Pre-post measures and a single-blinded, randomized controlled trial comprised the study's design. The study will be carried out in the Gamal Abdel Nasser Hospital's intensive care unit at the Health Insurance Organization in Alexandria, Egypt.

Ethical considerations:

Each patient and his family will be asked to sign a consent form before the current study begins, indicating their agreement to be part in it. Every patient and his family members will get a thorough explanation of how the assessment and treatment devices work. Each patient and his family will also receive an explanation of the rationale behind the examination and treatment methods

.

Eligibility criteria: Inclusion Criteria:

* Patients will be included in the study if they have the following criteria:

  1. Sixty male mechanically ventilated patients. They will be ventilated on pressure support (PS) mode of MV with this setting (Positive end-expiratory pressure \[PEEP\]) less than 8 cm H2O, FiO2 0.4 or less, SpO2 higher than 90) due to AECOPD.
  2. Their Glasgow Coma Scale score will be ranged from 13 to 15.
  3. Their age between 50 and 60 years old.
  4. Their BMI will be ranged from 25 to 34.9 kg/m2.
  5. Moderate (GOLD 2) and severe (GOLD 3) stages of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) grading system for the severity of COPD.

Exclusion Criteria:

* The patients will be excluded from this study if they have one of the following criteria:

Fever above 38.3 °C. Unstable hemodynamics. Thoracic or abdominal surgery that preclude the use of PNF exercises. Chest trauma such as rib fracture, flail chest and thoracic vertebra fracture or chest burns.

Peripheral and central nervous system diseases. Active lung infection like tuberculosis. Active bleeding as alveolar hemorrhage, hemoptysis. Spinal cord injuries involved the phrenic nerve. Severe cardiac complications due to COPD.

Primary outcomes:
measure: Blood gases analysis
timeFrame: immediately after the intervention
measure: C- reactive protein analysis
timeFrame: immediately after the intervention
measure: Assessment of weaning parameters
timeFrame: during the assessment time
measure: Oxygenation Index
timeFrame: immediately after the intervention
measure: Assessment of chest expansion
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Weaning success rate:
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Gamal Abdelnasser Hospital
state: Aleksandria
Study officials:
References: