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NCT Number: NCT07536347

Effect of Adding PNF to IMT on Weaning Off MV

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.

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Key information

Conditions

Weaning From Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • intervention group 1:include 31 mechanically ventilated patients will receive inspiratory muscle training along with Conventional rehabilitation program plus medical treatment.
  • intervention group 2: include 31 mechanically ventilated patients will receive inspiratory muscle training combined with proprioceptive neuromuscular facilitation along with Conventional rehabilitation program plus medical treatment.
  • Control group: include 31 mechanically ventilated patients will receive Conventional rehabilitation program plus medical treatment.

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.
  • Fiao2
  • PEEP
  • Tidal Volume
  • Respiratory Rate
  • The Duration and Type of Weaning:
  • Simple
  • Prolonged
  • Difficult
  • The patient vital signs:
  • Heart rate
  • Respiratory rate
  • Oxygen saturation
  • 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults of both sexes
  • patients older than 18 years
  • Conscious and cooperative
  • Hemodynamic stability without significant vasopressor support.
  • No continuous sedation.
  • Mechanically ventilated due to type 1 or type 2 respiratory failure (RF) for at least 24 hours.
  • Mechanically ventilated in assisted ventilation mode
  • Are able to participate in training actively, weanable as regard shallow breathing index.
  • 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), oxy-hemoglobin saturation (SaO2) > 90% with FiO2≤ 50%, positive end expiratory pressure (PEEP) ≤ 8 cmH2O, temperature between 36 and 39 °C.

Exclusion criteria

  • 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
  • Rib fractures
  • Current pregnancy
  • Cardiac arrest with a guarded neurological prognosis
  • Deep coma

Treatment and study plan

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.

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.

Primary outcomes

  1. • Time to Successful weaning

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

    Successful weaning: defined as sustained spontaneous breathing >48 hours post-extubation without need for reintubation or non-invasive ventilation.

  2. • Maximum inspiratory pressure

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

    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")

  3. • Diaphragmatic excursion

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

    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.

Secondary outcomes

  1. • ICU length of stay

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

    The number of days from ICU admission to ICU discharge

  2. Lung compliance

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

    Lung compliance: Calculated based on the following formula:

    Static compliance=Tidal volume / plateau pressure-PEEP Dynamic compliance=Tidal volume / peak inspiratory pressure-PEEP

  3. Classification of patients according to the weaning process

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

    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

Study contacts

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

Mahmoud I Mahmoud, lecturer

CONTACT

[email protected]

00201142998414

Mohammed SH Attya, master degree

CONTACT

[email protected]

+201158268850

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effect of Adding Proprioceptive Neuromuscular Facilitation to Inspiratory Muscle Training on Weaning Off Mechanical Ventilation

Acronym: PNF/IMT/MV

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

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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