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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.
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:
Instrumentations:
A) Evaluation:
All the following will be measured for all patients who will participate in this study
ICU length of stay.
Monitoring:
Mode of ventilation parameters.
The Duration and Type of Weaning:
The patient vital signs:
Maximum inspiratory pressure
Laboratory investigation:
- Arterial Blood Gases (ABG): for measurement of Pao2, Partial pressure of CO2 (Paco2), Hco3 and PH
Sonar parameters:
- Diaphragmatic excursion.
APHACH II score
Shallow breathing index.
Lung compliance: - Static and dynamic
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group (A) threshold inspiratory muscle training | Active Comparator | 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 rate, pulse oxygen, and respiratory rate are relatively stable during inspiratory training, the inspiratory resistance will be increased by 1-2 cm H2O per day. the resistance will be adjusted every day to be 50% of the new maximum inspiratory pressure then 1-2 cm H2O added. Each patient performed 6 breaths × five sets × twice daily × 5 days/ week. Until patients are weaned from mechanical ventilation. |
|
| group (B) PNF training + IMT | Active Comparator | 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. Including four 90-second manual stimulations each (upper ribs, lower ribs, sternum, and diaphragm). After every stimulation the patient rested for one minute. |
|
| group(C) Conventional Chest Physiotherapy only | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| threshold inspiratory muscle training + conventional chest physiotherapy | Device | 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 rate, pulse oxygen, and respiratory rate are relatively stable during inspiratory training, the inspiratory resistance will be increased by 1-2 cm H2O per day. the resistance will be adjusted every day to be 50% of the new maximum inspiratory pressure then 1-2 cm H2O added. Each patient performed 6 breaths × five sets × twice daily × 5 days/ week. Until patients are weaned from mechanical ventilation. |
| Measure | Description | Time Frame |
|---|---|---|
| • Time to Successful weaning | Successful weaning: defined as sustained spontaneous breathing >48 hours post-extubation without need for reintubation or non-invasive ventilation. | From enrollment to the end of treatment (an average of 7 to 14 days) |
| • Maximum inspiratory pressure | Maximum inspiratory pressure: to determine the inspiratory muscle strength before and after training. To measure the "negative inspiratory force" (NIF) through the ventilator settings menu (often available under "special procedures" or "lung mechanics") | From enrollment to the end of treatment (an average of 7 to 14 days) |
| • Diaphragmatic excursion | Diaphragmatic movement is evaluated using (sonoscape sonar). The right hemidiaphragm is examined by two-dimensional (2D) and M-mode to record diaphragm excursion (displacement). The probe is placed immediately below the right costal margin in the midclavicular line in longitudinal scanning plane with the angle in cephalad direction to make the ultrasound beam perpendicular to the posterior third of the right hemidiaphragm and with the liver serving as an acoustic window. | From enrollment to the end of treatment (an average of 7 to 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| • ICU length of stay | The number of days from ICU admission to ICU discharge | From enrollment to the end of treatment (an average of 7 to 14 days) |
| Lung compliance | Lung compliance: Calculated based on the following formula: Static compliance=Tidal volume / plateau pressure-PEEP Dynamic compliance=Tidal volume / peak inspiratory pressure-PEEP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed SH Attya, master degree | Contact | +201158268850 | mohammedbnshaaban2@gmail.com | |
| Mahmoud I Mahmoud, lecturer | Contact | 00201142998414 | Mahmoud.ibrahim@pt.bsu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Sherine H Mehani, professor | Beni-Suef University | Principal Investigator |
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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.
|
|
| proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy | Device | 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. Including four 90-second manual stimulations each (upper ribs, lower ribs, sternum, and diaphragm). After every stimulation the patient rested for one minute. |
|
| Conventional Chest Physiotherapy | Other | 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. |
|
| From enrollment to the end of treatment (an average of 7 to 14 days) |
| Classification of patients according to the weaning process | Into 3 Groups: Simple weaning Patients who proceed from initiation of weaning to successful extubation on the first attempt without difficulty. Difficult weaning Patients who fail initial weaning and require up to three SBT or as long as 7 days from the first SBT to achieve successful weaning. Prolonged weaning Patients who fail at least three weaning attempts or require 7 days of weaning after the first SBT | From enrollment to the end of treatment (an average of 7 to 14 days) |
| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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