Respiratory FailurePhase 1PNF techniquesNCT06831201
Effect of Different Proprioceptive Neuromuscular Facilitation Techniques Versus Flow Trigger Sensitivity on Weaning Off Mechanical Ventilation
A Phase 1 study testing Flow trigger sensitivity group, Active proprioceptive facilitation technique ( active PNF) technique and Passive proprioceptive facilitation technique ( passive PNF) technique in people with Respiratory Failure, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Flow trigger sensitivity group, Active proprioceptive facilitation technique ( active PNF) technique and Passive proprioceptive facilitation technique ( passive PNF) technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 1 Apr 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Thoracic or abdominal surgery precluding the use of PNF exercises.
- Rib fractures.
- Current pregnancy.
- Cardiac arrest with guarded neurological prognosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Prof. Dr. Sherin Hassan Mehani, Professor of Physical Therapy contact
Prof. Dr. Sherin Hassan Mehani, Professor of Physical Therapy contact
About this study
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.
Read more
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.
Read the 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
- Conditions
- Respiratory Failure
- Being tested
- Flow trigger sensitivity group, Active proprioceptive facilitation technique ( active PNF) technique, Passive proprioceptive facilitation technique ( passive PNF) technique
- Keywords
- Mechanical ventilation, Flow triggering senstivity, Different proprioceptive techniques
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow trigger sensitivity groupDevice
- 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) techniqueProcedure or surgery
- 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) techniqueProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Trigger sensitivity training | Experimental | *Training will be based on decreasing the trigger sensitivity gradually in order to increase muscle endurance. Receives: Device: Flow trigger sensitivity group |
| Active proprioceptive facilitation technique (active PNF technique) | Active comparator | PNF techniques included one session of physiotherapy including four 90-second manual stimulations each (upper ribs, lower ribs, sternum, and diaphragm). First, patients in this group will be treated with the rhythmic initiation technique (RIT) derived from the PNF concept. This technique facilitates the correct movement pattern, improves coordination and movement awareness of the chest wall.
Second, patients in this group will be treated with the initial stretch technique (IST), a technique also originating from the PNF concept (named also as: repeated stretch from beginning of range or repeated initial stretch).This technique facilitates the initiation of inhalation. Receives: Procedure: Active proprioceptive facilitation technique ( active PNF) technique |
| Passive proprioceptive facilitation technique ( passive PNF technique ) | Active comparator | Passive PNF methods are those involving the application of external proprioceptive and tactile stimuli producing reactions to reflex respiratory movement that appear to change breathing frequency and depth by this mechanism control and coordination movements of thoracic cage were facilitated and there is improvement in chest expansion and compliance. those methods include Perioral Pressure, Expanded epigastric movement ,Intercostal Stretch, Thoracic Vertebral Pressure, Co-contraction of the Abdomen ,Moderate Manual Pressure, Anterior Stretch-Lifting of the Posterior Basal Area (Basal Lift). Receives: Procedure: Passive proprioceptive facilitation technique ( passive PNF) technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure (MIP )
Maximum inspiratory pressure (MIP ) is the "Negative inspiratory force" (NIF) , which is considered as a sensitive measure of respiratory muscle strength
Measured: 10 days
Weaning success
weaning success is defined as extubation from mechanical ventilator without reintubation or death within 48 hours.
Measured: 10 days
Secondary outcomes (8)
Compliance (mL/cmH2O)
- Static lung compliance
Measured: 10 days
Respiratory rate
Respiratory Rate (RR) (breaths/min)
Measured: 10 days
duration of mechanical ventilation
Duration of mechanical ventilation.
.
Measured: 10 days
Percentage of oxygen saturation
Percentage of oxygen saturation
Measured: 10 days
Shallow rapid breathing index
Shallow rapid breathing index breath/min/ litter
Measured: 10 days
Friction of inspired oxygen
Friction of inspired oxygen (FIO2)
Measured: 10 days
Length of ICU stay
Length of ICU stay
Measured: 10 days
Dynamic lung compliance
Dynamic lung compliance
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasmin sabry abdelnabi hassan, Beni-Suef University
- Investigators
- Sherin Hassan Mehani, Professor of Physical Therapy, Principal investigator, Faculty of Physical Therapy , Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831201
- Sponsor's protocol ID
- FPTBSUREC/0103/241124
- Acronym
- PNF techniques
- Status last verified
- Dec 2024
- First submitted
- 27 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and summary of the results will be shared
Publications
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.
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.
PubMed 35055783de 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.
PubMed 32059691Elbouhy, 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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Proprioceptive Neuromuscular Facilitation Techniques Versus Flow Trigger Sensitivity on Weaning Off Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06831201
- Acronym / sponsor ID
- PNF techniques / FPTBSUREC/0103/241124
- Conditions
- Respiratory Failure
- Keywords
- Mechanical ventilation, Flow triggering senstivity, Different proprioceptive techniques
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trigger sensitivity training | Experimental | Device: Flow trigger sensitivity group*Training will be based on decreasing the trigger sensitivity gradually in order to increase muscle endurance. |
| Active proprioceptive facilitation technique (active PNF technique) | Active comparator | Procedure: Active proprioceptive facilitation technique ( active PNF) techniquePNF techniques included one session of physiotherapy including four 90-second manual stimulations each (upper ribs, lower ribs, sternum, and diaphragm). First, patients in this group will be treated with the rhythmic initiation technique (RIT) derived from the PNF concept. This technique facilitates the correct movement pattern, improves coordination and movement awareness of the chest wall. Second, patients in this group will be treated with the initial stretch technique (IST), a technique also originating from the PNF concept (named also as: repeated stretch from beginning of range or repeated initial stretch).This technique facilitates the initiation of inhalation. |
| Passive proprioceptive facilitation technique ( passive PNF technique ) | Active comparator | Procedure: Passive proprioceptive facilitation technique ( passive PNF) techniquePassive PNF methods are those involving the application of external proprioceptive and tactile stimuli producing reactions to reflex respiratory movement that appear to change breathing frequency and depth by this mechanism control and coordination movements of thoracic cage were facilitated and there is improvement in chest expansion and compliance. those methods include Perioral Pressure, Expanded epigastric movement ,Intercostal Stretch, Thoracic Vertebral Pressure, Co-contraction of the Abdomen ,Moderate Manual Pressure, Anterior Stretch-Lifting of the Posterior Basal Area (Basal Lift). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow trigger sensitivity group1. 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. | Device | Trigger sensitivity training |
| Active proprioceptive facilitation technique ( active PNF) technique1. 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. 2. 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 | Procedure or surgery | Active proprioceptive facilitation technique (active PNF technique) |
| Passive proprioceptive facilitation technique ( passive PNF) techniquePerioral 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 | Procedure or surgery | Passive proprioceptive facilitation technique ( passive PNF technique ) |
Primary outcome
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
Weaning success
Time frame: 10 days
weaning success is defined as extubation from mechanical ventilator without reintubation or death within 48 hours.
8 secondary outcomes
Compliance (mL/cmH2O)
Time frame: 10 days
Respiratory rate
Time frame: 10 days
duration of mechanical ventilation
Time frame: 10 days
Percentage of oxygen saturation
Time frame: 10 days
Shallow rapid breathing index
Time frame: 10 days
Friction of inspired oxygen
Time frame: 10 days
Length of ICU stay
Time frame: 10 days
Dynamic lung compliance
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- BackgroundAshtankar, 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.
- Background: PubMed 35055783Zwolinski 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.
- Background: PubMed 32059691de 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.
- BackgroundElbouhy, 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.
- BackgroundIsmail, 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.
- Individual participant dataSharing planned: Yes. The study protocol and summary of the results will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. Sherin Hassan Mehani, Professor of Physical Therapy contact
Prof. Dr. Sherin Hassan Mehani, Professor of Physical Therapy contact
Sherin Hassan Mehani, Professor of Physical Therapy principal investigator
Faculty of Physical Therapy , Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flow trigger sensitivity group, Active proprioceptive facilitation technique ( active PNF) technique and Passive proprioceptive facilitation technique ( passive PNF) technique in people with Respiratory Failure, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Sherin Hassan Mehani, Professor of Physical Therapy (01003378217, sherinhassin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum inspiratory pressure (MIP ) (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06831201, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.