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

Not Applicable

Recruiting

• Conditions: COPD Exacerbation Acute
• Interventions: Device: manual hyperinflation; Other: traditional physiotherapy; Other: Diaphragmatic proprioceptive neuromuscular facilitation technique

• Registration Number: NCT06221033
• Lead Sponsor: omar hasham mohamed

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

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Study Timeline

• Study Start: 2023-08-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manual hyperinflation group	manual hyperinflation	this group will receive manual hyper inflation technique as a treatment modality
control group	traditional physiotherapy	this group will receive the traditional physiotherapy techniques ( percussion , shaking , breathing ex )
diaphragmatic proprioceptive neuromuscular facilitation group	Diaphragmatic proprioceptive neuromuscular facilitation technique	this group will receive diaphragmatic proprioceptive neuromuscular facilitation technique

Primary Outcome Measures

Name	Time	Method
C- reactive protein analysis	immediately after the intervention	Each patient will be informed about the purpose of the test and how it will be done with keeping the explanation brief and in simple terms.; Each patient will be instructed to assume a relaxed comfortable position with loose clothes.; Initial step, phlebotomist will secure a snug rubber band around patient's upper arm, and the patient will be asked to pump his fist several times.; Then phlebotomist will palpate the vein, and will cleanse with an alcohol prep pad. Then practitioner will introduce a needle into the vein, and will draw a vial of blood.; After that the practitioner will remove the band, then remove the needle and apply pressure to venipuncture site up to one minute.; A bandage will be applied over the site. The test will be conducted for all patients pre and post the treatment program duration.; Normal finding for C-reactive protein (CRP) is \< 1.0 mg/dL or \<10.0 mg/L (SI units) (\< 3 mg/L for high-sensitivity CRP \[hs-CRP\]),
Blood gases analysis	immediately after the intervention	Each patient will be informed about the purpose of the test and how it will be done with keeping the explanation brief and in simple terms.; Each patient will be informed to assume a relaxed comfortable position with loose clothes.; Arterial blood samples will be taken via arterial line which is accessible and less painful.; The collected arterial blood sample will be sent for laboratory investigation according to ICU department laboratory communication protocol of Gamal Abdel Nasser Hospital.; The test will be conducted for all patients pre and post the treatment program duration.
Assessment of chest expansion	immediately after the intervention	Each patient will be informed about the purpose of the test and how it will be done with keeping the explanation brief and in simple terms.; Each patient will assume a comfortable half lying suping position. Marking will be done at 3 levels; axillary, nipple and xiphisterna. Patient will be asked to first take some normal breaths as a breath control technique for relaxation. Then will be asked to exhale completely and then inhale maximally as much as he can and hold breath for a second.; The difference between maximum exhalation and inhalation will be recorded during holding breath using a measuring tape at all three-level mentioned above. This procedure will be repeated three times and then the best value will be recorded The chest expansion will be measured for all patients pre and post the treatment program duration
Assessment of weaning parameters	during the assessment time	The weaning process will be indicated according to the following criteria; Adequate oxygenation" PaO2/FIO2 ratio ≥ 200, FIO2≤ 0.40, PaO2 ≥ 60, PaCO2 and PEEP ≤ 5 cmH2O", PH ≥ 7.30, Respiratory rate ≤ 45 bpm, Heart rate ≤ 140 bpm, RSBI ≤ 8 breaths/min/ml/kg body weight, Hemodynamic stability" no or minimal vasopressors or inotropes", Appropriate level of conscious, No continuous sedation infusion nor neuromuscular blocking agents, Afebrile, Adequate hemoglobin ≥8 g/dl and/or no evidence of hemorrhage
Oxygenation Index	immediately after the intervention	Oxygenation index is the better indicator for defining of lung injury compared to the PaO2/FiO2 ratio as it includes mean airway pressure (MAP), also it is an important determinant of oxygenation of acute respiratory failure, which evaluated according the following equation (PaO2/ FiO2) \<300 mmHg with or without elevated arterial carbon dioxide tension (PaCO2) (Liu et al., 2015). OI is a commonly used to assess the severity of hypoxic respiratory failure (HRF) and persistent pulmonary hypertension OI = mean airway pressure MAP (in cmH2O) × FiO2 × 100 ÷ PaO2 . Where FiO2: Fraction of inspired oxygen in percent. MAP: Mean airway pressure in mmHg. FiO2: Fraction of inspired oxygen. PaO2: Partial pressure of oxygen in arterial blood in mmHg. The oxygenation index will be recorded for all patients pre and post the treatment program duration.

Secondary Outcome Measures

Name	Time	Method
Weaning success rate:	immediately after the intervention	Weaning success defined as spontaneous breathing without mechanical support for at least 48 hours. Weaning success rate, a proportion of successfully weaned patients to total number of patients receiving a treatment program, was recorded for three study groups post the treatment program duration

Trial Locations

Locations (1)

Gamal Abdelnasser Hospital; 🇪🇬 Alexandria, Aleksandria, Egypt