Comparing the Effects of Manual Hyperinflation and Diaphragmatic Proprioceptive Neuromuscular Facilitation on Pulmonary Functions in Patients on Mechanical Ventilation

NCT ID: NCT06221033

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-04-01

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

.

Conditions

COPD Exacerbation Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

manual hyperinflation group

this group will receive manual hyper inflation technique as a treatment modality

Group Type: EXPERIMENTAL

manual hyperinflation

Intervention Type: DEVICE

Each participant will assume a relaxed comfortable in supine position. Bag valve resuscitation circuit locked at pressure 35 cm H20 will be used. Six sets of six MHI breaths will be applied. MHI breaths had a slow inspiration for three seconds duration, a three second end inspiratory pause (hold) then an uninterrupted expiration as a quick release

diaphragmatic proprioceptive neuromuscular facilitation group

this group will receive diaphragmatic proprioceptive neuromuscular facilitation technique

Group Type: EXPERIMENTAL

Diaphragmatic proprioceptive neuromuscular facilitation technique

Intervention Type: OTHER

Rhythmic initiation technique that is derived from the PNF concept will be initiated by four 20-second manual diaphragm stimulations. After every stimulation the patient rested for one minute. Therapist's hands will be placed below the rib cage, just below the costal arches and will support patient's exhalation phase by slight lengthening his diaphragm simultaneously in posterior-superior direction using a verbal cue "exhale". At the same time, the patient will verbally be encouraged to take a deep breath

control group

this group will receive the traditional physiotherapy techniques ( percussion , shaking , breathing ex )

Group Type: OTHER

traditional physiotherapy

Intervention Type: OTHER

This group will receive the traditional medical treatment and chest physiotherapy only.

Interventions

manual hyperinflation

Each participant will assume a relaxed comfortable in supine position. Bag valve resuscitation circuit locked at pressure 35 cm H20 will be used. Six sets of six MHI breaths will be applied. MHI breaths had a slow inspiration for three seconds duration, a three second end inspiratory pause (hold) then an uninterrupted expiration as a quick release

Intervention Type: DEVICE

Diaphragmatic proprioceptive neuromuscular facilitation technique

Rhythmic initiation technique that is derived from the PNF concept will be initiated by four 20-second manual diaphragm stimulations. After every stimulation the patient rested for one minute. Therapist's hands will be placed below the rib cage, just below the costal arches and will support patient's exhalation phase by slight lengthening his diaphragm simultaneously in posterior-superior direction using a verbal cue "exhale". At the same time, the patient will verbally be encouraged to take a deep breath

Intervention Type: OTHER

traditional physiotherapy

This group will receive the traditional medical treatment and chest physiotherapy only.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

omar hasham mohamed

OTHER

Sponsor Role: lead

Responsible Party

omar hasham mohamed

physiotherapist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gamal Abdelnasser Hospital

Alexandria, Alexandria Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

omar hesham, Bsc

Role: CONTACT

ohesham1995@gmail.com

01116654844

Facility Contacts

omar hesham, Bsc

Role: primary

ohesham1995@gmail.com

01116654844

Other Identifiers

P.T.REC/012/004933

Identifier Type: -

Identifier Source: org_study_id