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

NCT06221033 | Unknown

• 1 other identifier: P.T.REC/012/004933
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

COPD Exacerbation Acute

Outcome Measures

Primary Outcomes (5)

• Blood gases analysis

  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.

  immediately after the intervention

• C- reactive protein analysis

  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 \[hs-CRP\]),

  immediately after the intervention

• Assessment of weaning parameters

  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

  during the assessment time

• Oxygenation Index

  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.

  immediately after the intervention

• Assessment of chest expansion

  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

  immediately after the intervention

Secondary Outcomes (1)

• Weaning success rate:

  immediately after the intervention

Study Arms (3)

manual hyperinflation group

EXPERIMENTAL

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

Device: manual hyperinflation

diaphragmatic proprioceptive neuromuscular facilitation group

EXPERIMENTAL

this group will receive diaphragmatic proprioceptive neuromuscular facilitation technique

Other: Diaphragmatic proprioceptive neuromuscular facilitation technique

control group

OTHER

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

Other: traditional physiotherapy

Interventions

manual hyperinflation 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

manual hyperinflation group

Diaphragmatic proprioceptive neuromuscular facilitation technique 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

diaphragmatic proprioceptive neuromuscular facilitation group

traditional physiotherapy OTHER

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

control group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be included in the study if they have the following criteria:
• 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.
• Their Glasgow Coma Scale score will be ranged from 13 to 15.
• Their age between 50 and 60 years old.
• Their BMI will be ranged from 25 to 34.9 kg/m2.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• omar hasham mohamed: lead

Study Sites (1)

Gamal Abdelnasser Hospital

Alexandria, Alexandria Governorate, 4027, Egypt

RECRUITING

Central Study Contacts

omar hesham, Bsc

CONTACT

01116654844; ohesham1995@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 24, 2024
• Study Start: August 30, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

EG (1)