Clinical trial NCT06831201: Effect of Different Proprioceptive Neuromuscular Facilitation Techniques Versus Flow Trigger Sensitivity on Weaning Off Mechanical Ventilation
Official title: Effect of Different Proprioceptive Neuromuscular Facilitation Techniques Versus Flow Trigger Sensitivity on Weaning Off Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Respiratory Failure
Keywords: Mechanical ventilation
Flow triggering senstivity
Different proprioceptive techniques
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Weaning is a critical stage in respiratory care, requiring strategies to optimize breathing muscle function and reduce patient dependence on ventilatory support.

PNF Techniques: These techniques are traditionally used to improve muscle strength and coordination. When applied to respiratory therapy, PNF can enhance diaphragmatic strength, improve chest wall mobility, and promote effective breathing patterns, potentially accelerating the weaning process.

Flow Trigger Sensitivity: This approach focuses on fine-tuning ventilator settings to ensure minimal patient effort in initiating breaths. By improving patient-ventilator synchronization, it reduces respiratory muscle fatigue and supports efficient weaning.

The study likely compares the two approaches in terms of weaning success rates, duration, and respiratory muscle performance. It may conclude that combining PNF techniques with optimized ventilator settings can improve weaning outcomes by enhancing respiratory muscle functionality and reducing mechanical ventilation dependency.

Detailed description: PURPOSE The main aim of this study is to compare the effect of Different proprioceptive neuromuscular facilitation techniques versus Flow Trigger Sensitivity On Weaning Off Mechanical Ventilation BACKGROUND Respiratory failure occurs when the respiratory system fails adequately to oxygenate or eliminate carbon dioxide from the blood. Under such circumstances, mechanical ventilation is used to meet these demands artificially. When the precipitating cause of respiratory failure is corrected, most patients can easily resume spontaneous breathing and do not require any elaborate "weaning" techniques. In a few cases, however, especially when the precipitating cause cannot be completely corrected or when the complications of mechanical ventilation have aggravated respiratory failure, the patient cannot readily resume the work of breathing. In such cases, gradual weaning can usually allow mechanical ventilation to be discontinued safely and without excessive discomfort. Sometimes, unfortunately, the response to gradual weaning is poor; these patients continue to present a challenge to pulmonary and critical care physicians .

Mechanical ventilation (MV) supports breathing in critically ill patients in the setting of intensive care unit (ICU). Although indispensable, MV has been implicated in the dysfunction of the diaphragm and respiratory muscle weakness. Weaning from mechanical ventilation can be defined as the process of gradually withdrawing ventilatory support and liberating the patient from the endotracheal tube. The weaning process represents the 40-50% of the total duration of mechanical ventilation. Furthermore, a 26-42% rate of weaning failure has been reported after a single spontaneous breathing trial (SBT).It is well documented that weakness of the inspiratory muscles is a cause of weaning failure. Prolonged MV promotes diaphragmatic weakness due to both atrophy and contractile dysfunction. In addition, prolonged MV and weaning failure are indicators of poor prognosis. Prolonged ventilation increases the risk of complications, such as infections and critical illness neuromuscular syndromes Patients in the intensive care unit (ICU) who experience invasive mechanical ventilation for more than 72 h are susceptible to inspiratory muscle weakness. In patients invasively ventilated for longer than 7 days, this weakness manifests as impairments in both inspiratory muscle strength and endurance soon after ventilatory weaning. These impairments may contribute to elevated dyspnea in ICU patients both at rest and during exercise and thus hamper functional recovery. As ICU survivors often have poor levels of physical function and poor quality of life, interventions which improve strength and quality of life should be a priority for the healthcare team HYPOTHESES There is no difference between the effect of proprioceptive neuromuscular facilitation techniques versus Flow Trigger Sensitivity On Weaning Off Mechanical Ventilation

RESEARCH QUESTION:

Is there unique effect between Different proprioceptive neuromuscular facilitation techniques versus Flow Trigger Sensitivity On Weaning Off Mechanical Ventilation

Eligibility criteria: Inclusion Criteria:

1. Eighty four mechanically ventilated ICU patients under supervision; their age will be above 18 years old.
2. Mechanically ventilated due to type 1 or type 2 respiratory failures (RF) for at least 24 hours and Candidate for early extubation.
3. All patients are conscious and co-operative
4. All patients able to participate in training actively, weanable as regard to readiness weaning
5. All patients are hemodynamically stable.
6. Patient will be assigned in to three groups.
7. Presence of weaning criteria as defined in the European consensus conference in 2007, including sedation reduction, spontaneous breathing cycles, partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2)150, absence of inotropes or vasopressors at high doses or increasing doses ( 1 mg/h),oxyhaemoglobin saturation (SaO2) 90% with FiO2 50% , positive end expiratory pressure (PEEP) 8 cmH2O,temperature is less than 38 ◦C.

Exclusion Criteria:

1. Hemodynamic or respiratory instability.
2. Condition that compromise weaning such as heart failure.
3. Condition that can prevent adequate performance of inspiratory muscle training such as neuropathy or myopathy.
4. Active hemorrhage and hemoptysis.
5. Large pneumothorax and pulmonary embolism.
6. Poor cognition and mentality.
7. Thoracic or abdominal surgery precluding the use of PNF exercises.
8. Rib fractures.
9. Current pregnancy.
10. Cardiac arrest with guarded neurological prognosis.

Primary outcomes:
measure: Maximum inspiratory pressure (MIP )
timeFrame: 10 days
measure: Weaning success
timeFrame: 10 days
Secondary outcomes:
measure: Compliance (mL/cmH2O)
timeFrame: 10 days
measure: Respiratory rate
timeFrame: 10 days
measure: duration of mechanical ventilation
timeFrame: 10 days
measure: Percentage of oxygen saturation
timeFrame: 10 days
measure: Shallow rapid breathing index
timeFrame: 10 days
measure: Friction of inspired oxygen
timeFrame: 10 days
measure: Length of ICU stay
timeFrame: 10 days
measure: Dynamic lung compliance
timeFrame: 10 days
Other outcomes:
Locations:
city: Beni Suef
country: Egypt
facility: Beni-Suef University
Study officials:
affiliation: Faculty of Physical Therapy , Beni-Suef University
name: Sherin Hassan Mehani, Professor of Physical Therapy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashtankar, A. P., Kazi, A., & Chordiya, S. (2019). Comparative effect of Proprioceptive Neuromuscular Facilitation (PNF) and chest physiotherapy with chest physiotherapy alone on SP02, heart rate, respiratory rate, & lung compliance in mechanically ventilated patient. J Pharm Sci Res, 11(10), 3514-8.
citation: Zwolinski T, Wujtewicz M, Szamotulska J, Sinoracki T, Waz P, Hansdorfer-Korzon R, Basinski A, Gosselink R. Feasibility of Chest Wall and Diaphragm Proprioceptive Neuromuscular Facilitation (PNF) Techniques in Mechanically Ventilated Patients. Int J Environ Res Public Health. 2022 Jan 15;19(2):960. doi: 10.3390/ijerph19020960.
citation: de Souza RJP, Brandao DC, Martins JV, Fernandes J, Dornelas de Andrade A. Addition of proprioceptive neuromuscular facilitation to cardiorespiratory training in patients poststroke: study protocol for a randomized controlled trial. Trials. 2020 Feb 14;21(1):184. doi: 10.1186/s13063-019-3923-1.
citation: Elbouhy, M. S., AbdelHalim, H. A., & Hashem, A. M. (2014). Effect of respiratory muscles training in weaning of mechanically ventilated COPD patients. Egyptian Journal of Chest Diseases and Tuberculosis, 63(3), 679-687.
citation: Ismail, O. A., El-Nahass, N. G., Abdeen, H. A., & Soliman, Y. (2021). Effect of Modifying Mechanical Ventilator Trigger Sensitivity on Arterial Blood Gases in ICU Patients. The Egyptian Journal of Hospital Medicine, 85(2), 3767-3771.