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NCT Number: NCT06831201

Effect of Different Proprioceptive Neuromuscular Facilitation Techniques Versus Flow Trigger Sensitivity on Weaning Off Mechanical Ventilation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eighty four mechanically ventilated ICU patients under supervision; their age will be above 18 years old.
  • Mechanically ventilated due to type 1 or type 2 respiratory failures (RF) for at least 24 hours and Candidate for early extubation.
  • All patients are conscious and co-operative
  • All patients able to participate in training actively, weanable as regard to readiness weaning
  • All patients are hemodynamically stable.
  • Patient will be assigned in to three groups.
  • 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

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

Treatment and study plan

Flow trigger sensitivity group

Device
  • Pressure support ventilation will be titrated at a level sufficient to achieve a respiratory rate of 20-30 breath/min and tidal volume 4-6 ml/kg. Pressure support will be reduced by 2 cm H2O every hour to reach pressure support 8 cm H2O. Two exercise sessions will be performed, at 9 AM and 5 PM. Training will be based on decreasing the trigger sensitivity gradually in order to increase muscle endurance. The trigger sensitivity will be adjusted to 20% of the first recorded MIP at the start of training (In the first session), inspiratory muscle training (IMT) will be limited to 5 min; afterwards the duration will be increased by 5 min at every session until it reach 30 min. If a patient tolerates 30 min of IMT, The next session will be performed with increasing trigger sensitivity by 10% of the initial MIP. Patients who could not tolerate IMT with 20% of MIP for 5 min were trained with 10% of MIP. Training consists of 5 to 6 sets of repetitions through the trainer.

Active proprioceptive facilitation technique ( active PNF) technique

Procedure
  • patients in this group treated with the rhythmic initiation technique derived from the PNF concept. The RIT will be applied in four manual positions of the therapist's hands: The upper and lower chest wall, the sternum and below the rib cage, so that the patient can learn the correct breathing pattern. Verbal commands will be also used by the PT to reinforce the manual stimulation with each pattern/exercise being performed 10 times.
  • patients treated with the initial stretch technique ,This technique facilitates the initiation of inhalation. The IST was applied to help the patient to initiate the inhalation phase, increase the force developed by the inspiratory muscle, and to enhance the active range of motion of the chest wall and the diaphragm. At the final stage of exhalation, when inspiratory muscles will be elongated optimally, the stretch reflex will be initiated by applying a quick tap to elicit a strong and active inspiratory muscle contraction

Passive proprioceptive facilitation technique ( passive PNF) technique

Procedure

Perioral pressure is provided by applying pressure with the therapist's finger on the top lip between the nose and lip. The pressure is maintained for the length of time that the therapist wishes the patient to breathe in the activated pattern.

Intercostal stretch is provided by applying pressure to the upper border of a rib in order to stretch the intercostal muscle in a downward(not inward) direction. The stretch position is then maintained while the patient continues to breathe in his/her usual manner.

vertebral pressure high - manual pressure applied to thoracic vertebrae in the region T2 - T5.

vertebral pressure low - manual pressure applied to thoracic vertebrae in the region T9 - T10.

Co-contraction of the Abdomen Provided by the therapist by pressing adequate pressure on the lower ribs and pelvis on the same side, so that pressure is applied at right angles to the patient.

Moderate Manual Pressure of the open hand(s) is maintained over the area in which expansion is desired

Primary outcomes

  1. Maximum inspiratory pressure (MIP )

    Time frame: 10 days

    Maximum inspiratory pressure (MIP ) is the "Negative inspiratory force" (NIF) , which is considered as a sensitive measure of respiratory muscle strength

  2. Weaning success

    Time frame: 10 days

    weaning success is defined as extubation from mechanical ventilator without reintubation or death within 48 hours.

Secondary outcomes

  1. Compliance (mL/cmH2O)

    Time frame: 10 days

    a. Static lung compliance

  2. Respiratory rate

    Time frame: 10 days

    Respiratory Rate (RR) (breaths/min)

  3. duration of mechanical ventilation

    Time frame: 10 days

    Duration of mechanical ventilation.

    .

  4. Percentage of oxygen saturation

    Time frame: 10 days

    Percentage of oxygen saturation

  5. Shallow rapid breathing index

    Time frame: 10 days

    Shallow rapid breathing index breath/min/ litter

  6. Friction of inspired oxygen

    Time frame: 10 days

    Friction of inspired oxygen (FIO2)

  7. Length of ICU stay

    Time frame: 10 days

    Length of ICU stay

  8. Dynamic lung compliance

    Time frame: 10 days

    Dynamic lung compliance

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Dr. Sherin Hassan Mehani, Professor of Physical Therapy

CONTACT

[email protected]

01003378217

Prof. Dr. Sherin Hassan Mehani, Professor of Physical Therapy

CONTACT

[email protected]

+201003378217

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Acronym: PNF techniques

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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