Effect of Adding PNF to IMT on Weaning Off MV
ConditionWeaning From Mechanical Ventilation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeni-Suef University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults of both sexes
patients older than 18 years
Conscious and cooperative
Hemodynamic stability without significant vasopressor support.
Disqualifiers
Hemodynamic or respiratory instability
Condition that can compromise weaning, such as heart failure.
Condition that can prevent adequate performance of inspiratory muscle training, such as neuropathy or myopathy.
Thoracic or abdominal surgery precluding the use of PNF exercises
Trial design
Design model
Parallel
Treatments tested in this trial
threshold inspiratory muscle training + conventional chest physiotherapy
Devicethreshold 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.
proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy
DevicePNF 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 interventionConventional 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.
Treatment groups
93 Participants
are divided into 3 treatment groupsGroup A: group (A) threshold inspiratory muscle trainingActive comparator 1 intervention
Group B: group (B) PNF training + IMTActive comparator 1 intervention
Group C: group(C) Conventional Chest Physiotherapy onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
• Time to Successful weaning
Successful weaning: defined as sustained spontaneous breathing \>48 hours post-extubation without need for reintubation or non-invasive ventilation.
Time frame
From enrollment to the end of treatment (an average of 7 to 14 days)2
• 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")
Time frame
From enrollment to the end of treatment (an average of 7 to 14 days)3
• 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.
Time frame
From enrollment to the end of treatment (an average of 7 to 14 days)Secondary outcomes
1
• ICU length of stay
The number of days from ICU admission to ICU discharge
Time frame
From enrollment to the end of treatment (an average of 7 to 14 days)2
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
Time frame
From enrollment to the end of treatment (an average of 7 to 14 days)3
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
Time frame
From enrollment to the end of treatment (an average of 7 to 14 days)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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