Acute Respiratory FailureNCT05387720
Concurrent Trigger Sensitivity Adjustment And Diaphragmatic Facilitation On Weaning From Mechanical Ventilation
A study testing Manual diaphragmatic facilitation (PNF) technique, Trigger sensitivity adjustment on mechanical ventilation and concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique in people with Acute Respiratory Failure and Mechanically Ventilated Patients, run by Cairo University at 1 site in Egypt.
Trial summary
As Acute respiratory failure (ARF) is a challenging serious condition especially when it necessitates intubation to deliver mechanical ventilation which is a fundamental strategy for supporting the respiratory function when the patient can't bear all work of breathing. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Acute Respiratory Failure, Mechanically Ventilated Patients
- What is being tested?
- Manual diaphragmatic facilitation (PNF) technique, Trigger sensitivity adjustment on mechanical ventilation and concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes with age ranges (50-60) years old.
- Patients will be referred with acute respiratory failure (ARF) inside ICU.
- All patients are intubated and mechanically ventilated with assisted control (pressure or volume) or pressure support modes for 24-48 hours.
- All patients with positive end expiratory pressure (PEEP) don't exceed 10 cmH2o.
- All patients are hemodynamically stable; temperature (36.2-37.5) C, Heart rate < 140 /min, Blood pressure (systolic: <180mmHg and diastolic <100 mmHg), Respiratory rate < 35/min and oxygen saturation >90%
- All patients are conscious and responsive to verbal command.
Who cannot join
- Fraction of inspired oxygen (fio2)>0.6 and SPO2 < 85% to avoid further hypoxia and respiratory distress.
- Positive end expiratory pressure (PEEP) > 10 cmH2O to avoid barotrauma.
- Severe pulmonary condition; acute pulmonary embolism, undrained pneumothorax.
- Unstable hemodynamic condition as defined by heart rate more than 140 beats/min, systolic blood pressure >180 mmHg or Low blood pressure < 80 mmHg and respiratory rate is exceeding 35 breaths/min.
- Patients who develop any cardiac condition during the course of treatment; acute myocardial infarction or cardiac arrhythmia.
- Patients who recently have undergo cardiac or abdominal or gynecological surgery.
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- Active lung infection like tuberculosis.
- Chest trauma such as rib fracture, flail chest, thoracic vertebra fracture or chest burns.
- Spinal cord injuries involved the phrenic nerve.
- Active bleeding as alveolar hemorrhage, hemoptysis.
- Heavy sedation that depresses respiratory drive or ability to follow commands.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Trigger Sensitivity Adjustment And Diaphragmatic Facilitation On Weaning Of Patients From Mechanical Ventilation
As Acute respiratory failure (ARF) is a challenging serious condition especially when it necessitates intubation to deliver mechanical ventilation which is a fundamental strategy for supporting the respiratory function when the patient can't bear all work of breathing. Even if it represents a life-saving procedure, mechanical ventilation (MV) is associated to life-threatening complications as respiratory muscle dysfunction, and atrophy that lead to long stay in intensive care unit (ICU) and higher mortality. Weaning difficulty is experienced in nearly 30 percent of critically ill patients.
The decision to extubate mechanically ventilated patients should be aimed at preventing both the risk of premature liberation from MV which is associated with poor outcome and the risk of delayed extubation which increases the complications of prolonged MV and there is increasing evidence that MV itself may adversely affect the diaphragm's structure and function, which has been termed ventilator-induced diaphragmatic dysfunction (VIDD). The combination of positive pressure ventilation and positive end-expiratory pressure may unload the diaphragm which leads to changes in myofibril length and rapid atrophy that occurs within hours of MV, caused by an imbalance between protein synthesis and proteolysis, lead to a large reduction in the inspiratory pressure generated by the diaphragm.
Read the detailed description
Physiotherapist is a key member of multidisciplinary team and plays an vital role in ICU in improving the patient's quality of life, Inspiratory muscle training (IMT) applies a load to the diaphragm and accessory inspiratory muscles to increase their strength and endurance. Adjustment of ventilator sensitivity provides resistance and hence a pressure load to the inspiratory muscles, and proprioceptive neuromuscular facilitation (PNF) of respiration is newly introduced in ICU for patients who are ventilator dependent by use of external proprioceptive and tactile stimuli to assist respiration. PNF techniques improve inspiration and expiration in next cycle that shows improvement with active initiation or more participation in respiration to alter the rate and depth of breathing, facilitate respiratory muscles, improve breathing pattern and increase tidal volume So the purpose of this study is to determine the concurrent effect of trigger sensitivity adjustment and diaphragmatic facilitation on weaning of patients from mechanical ventilation. As the patients may gain a more benefit from the combination of trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) techniques than from each one alone. Therefore, a concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) techniques must likely be started within 24 to 48 hours of initiating MV to protect diaphragm from atrophy, facilitate faster weaning, minimize ICU stay and cost of treatment, and decrease the morbidity and mortality rate of those patients admitted to ICU.
Study Hypothesis:
It will be hypothesized that there is no effect of diaphragmatic facilitation on weaning of patients from mechanical ventilation.
It will be hypothesized that there is no effect of trigger sensitivity adjustment on weaning of patients from mechanical ventilation.
It will be hypothesized that there is no effect of a concurrent trigger sensitivity adjustment and diaphragmatic facilitation on weaning of patients from mechanical ventilation.
- Being tested
- Manual diaphragmatic facilitation (PNF) technique, Trigger sensitivity adjustment on mechanical ventilation, concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique
- Keywords
- Acute Respiratory Failure, Mechanical ventilation, Ventilator Induced diaphragmatic dysfunction, Proprioceptive neuromuscular training, Diaphragmatic facilitation, Diaphragmatic PNF, Inspiratory Muscle training, Trigger sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual diaphragmatic facilitation (PNF) techniqueProcedure or surgery
Also called Diaphragmatic PNF
Diaphragmatic PNF is a facilitator technique used to improve chest expansion, increase epigastric excursion, promote breathing frequency and depth, by applying external proprioceptive tactile stimuli over diaphragm. The therapist places the thumbs toward the xiphoid process and the fingers along the costal margins of the lower ribs and pushing deep to stimulate the diaphragm During inspiration, the patient will be instructed "take a deep breath breathe in" and the therapist assists the movement to promote the subject's respiratory pattern in downward movement. At the maximum inspiration, therapist will say "hold your breath for 5 seconds". The therapist gives mild resistance to the inferior movement of the contracting diaphragm during inspiration while pushing diaphragm superiorly. During expiration, therapist says "breathe out" and pushed under lower ribs on both sides upward to assist the discharge of air remaining in the lungs.
Trigger sensitivity adjustment on mechanical ventilationProcedure or surgery
Also called Trigger sensitivity
The pressure trigger sensitivity will be adjusted to 20% of the first recorded MIP at the start of training by decreasing trigger sensitivity towards negative pressure. 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 reaches 30 min. If a patient tolerates 30 min of IMT, The next session will be performed with increasing negative pressure of the trigger sensitivity by 10% of the initial MIP. The maximal acceptable intensity is 40% of MIP, Patients who can't tolerate IMT with 20% of MIP for 5 min will be trained with 10% of MIP
concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) techniqueProcedure or surgery
Diaphragmatic PNF technique will be applied synchronously in the same time, on each breath with trigger sensitivity adjustment on mechanical ventilation in same manner as discussed before
| Study group | Role | What they receive |
|---|---|---|
| Study Group A | Active comparator | Study Group A (25 patients) will receive manual diaphragmatic facilitation (PNF) technique in addition to traditional chest physiotherapy Receives: Procedure: Manual diaphragmatic facilitation (PNF) technique |
| Study Group B | Active comparator | Study Group B (25 patients) will receive trigger sensitivity adjustment on mechanical ventilator in addition to traditional chest physiotherapy. Receives: Procedure: Trigger sensitivity adjustment on mechanical ventilation |
| Study Group C | Active comparator | Study Group C (25 patients) will receive a concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique in addition to traditional chest physiotherapy. Receives: Procedure: concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood gases analysis
Blood gases analyzer(SIEMENS RAPIDLAB 1265, manufactured in 2008) is used in every clinical diagnosis lab or critical care facility to measure blood gases (PH, pco2 and po2), electrolytes, and metabolites parameters from whole blood samples. An arterial blood catheter (cannula) was inserted into the radial artery to draw blood sample of (2 to 3) ml, in a (3 to 5) ml plastic airtight syringe fitted with a small bore needled and filled with heparin.
The standard values: PH 7.35-7.45, PaCO2 35-45, PaO2 60-100, SPO2 95-100% and PaO2/FiO2 ratio >300.
Measured: Blood gases will be analyzed and recorded for all patients pre and post the treatment program duration 5 up to 7 days
Oxygenation Index (OI)
OI is recognized as the primary indicator for respiratory disease severity stratification in mechanically ventilated patients to assess the intensity of ventilatory support that needed to maintain adequate oxygenation and predict outcomes in patients with ARF.
OI = (FiO2 x MAP) / PaO2 OI normally, <15 as the lower the OI the better the outcome: as the oxygenation of the patient improves, they can achieve a higher PaO2 at a lower FiO2.
Measured: OI will be recorded for three study groups pre and post the treatment program duration 5 up to 7 days
Maximum Inspiratory Pressure (MIP)
MIP also known as negative inspiratory force (NIF); the maximum negative pressure generated for at least 1 second during maximal inspiratory effort against occluded airway that estimated inspiratory muscle strength mainly diaphragm. PImax has been widely used to quantify respiratory muscle weakness. PImax values of more than -25 cmH2O was considered as an index to predict weaning success.
To obtain reliable results, the maneuver will be performed three times, with a 1-min interval between readings. The highest value was chosen as PImax.
Measured: MIP will be measured digitally from the MV for all patients pre and post the treatment program duration 5 up to 7 days.
Rapid shallow breathing index (RSBI)
RSBI is an index used to predict weaning from MV, defined as the ratio of respiratory frequency to tidal volume (f/VT). People on MV who cannot tolerate independent breathing tend to breath rapidly (high frequency) and shallowly (low tidal volume) and will therefore have a high RSBI. RSBI<105 is reported to be the most accurate predictor of successful patient extubation.
ventilator mode was switched on CPAP with zero pressure support to divide f by Vt to obtain RSBI (f/Vt).
Measured: RSBI was measured for all patients pre and post the treatment program duration 5 up to 7 days
Weaning Success Rate
Weaning success is defined as spontaneous breathing without mechanical support for at least 48 hours. Weaning success rate (a proportion of successfully weaned patients to total number of patients receiving a treatment program)
Measured: it will be recorded for three study groups post the treatment program duration 5 up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Dec 2020
- Primary completion30 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Badran Mohamed Ismail, Cairo University
- Investigators
- Hany E Obaya, PHD, Study chair, Cairo UniversityEl sayed E El sayed, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387720
- Sponsor's protocol ID
- P.T.REC/012/002902
- Status last verified
- Aug 2023
- First submitted
- 19 May 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Trigger Sensitivity Adjustment And Diaphragmatic Facilitation On Weaning Of Patients From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05387720
- Acronym / sponsor ID
- P.T.REC/012/002902
- Keywords
- Acute Respiratory Failure, Mechanical ventilation, Ventilator Induced diaphragmatic dysfunction, Proprioceptive neuromuscular training, Diaphragmatic facilitation, Diaphragmatic PNF, Inspiratory Muscle training, Trigger sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 24 May 2022 (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.
As Acute respiratory failure (ARF) is a challenging serious condition especially when it necessitates intubation to deliver mechanical ventilation which is a fundamental strategy for supporting the respiratory function when the patient can't bear all work of breathing. Even if it represents a life-saving procedure, mechanical ventilation (MV) is associated to life-threatening complications as respiratory muscle dysfunction, and atrophy that lead to long stay in intensive care unit (ICU) and higher mortality. Weaning difficulty is experienced in nearly 30 percent of critically ill patients.
The decision to extubate mechanically ventilated patients should be aimed at preventing both the risk of premature liberation from MV which is associated with poor outcome and the risk of delayed extubation which increases the complications of prolonged MV and there is increasing evidence that MV itself may adversely affect the diaphragm's structure and function, which has been termed ventilator-induced diaphragmatic dysfunction (VIDD). The combination of positive pressure ventilation and positive end-expiratory pressure may unload the diaphragm which leads to changes in myofibril length and rapid atrophy that occurs within hours of MV, caused by an imbalance between protein synthesis and proteolysis, lead to a large reduction in the inspiratory pressure generated by the diaphragm.
Detailed description
Physiotherapist is a key member of multidisciplinary team and plays an vital role in ICU in improving the patient's quality of life, Inspiratory muscle training (IMT) applies a load to the diaphragm and accessory inspiratory muscles to increase their strength and endurance. Adjustment of ventilator sensitivity provides resistance and hence a pressure load to the inspiratory muscles, and proprioceptive neuromuscular facilitation (PNF) of respiration is newly introduced in ICU for patients who are ventilator dependent by use of external proprioceptive and tactile stimuli to assist respiration. PNF techniques improve inspiration and expiration in next cycle that shows improvement with active initiation or more participation in respiration to alter the rate and depth of breathing, facilitate respiratory muscles, improve breathing pattern and increase tidal volume So the purpose of this study is to determine the concurrent effect of trigger sensitivity adjustment and diaphragmatic facilitation on weaning of patients from mechanical ventilation. As the patients may gain a more benefit from the combination of trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) techniques than from each one alone. Therefore, a concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) techniques must likely be started within 24 to 48 hours of initiating MV to protect diaphragm from atrophy, facilitate faster weaning, minimize ICU stay and cost of treatment, and decrease the morbidity and mortality rate of those patients admitted to ICU.
Study Hypothesis:
It will be hypothesized that there is no effect of diaphragmatic facilitation on weaning of patients from mechanical ventilation.
It will be hypothesized that there is no effect of trigger sensitivity adjustment on weaning of patients from mechanical ventilation.
It will be hypothesized that there is no effect of a concurrent trigger sensitivity adjustment and diaphragmatic facilitation on weaning of patients from mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group A | Active comparator | Procedure: Manual diaphragmatic facilitation (PNF) techniqueStudy Group A (25 patients) will receive manual diaphragmatic facilitation (PNF) technique in addition to traditional chest physiotherapy |
| Study Group B | Active comparator | Procedure: Trigger sensitivity adjustment on mechanical ventilationStudy Group B (25 patients) will receive trigger sensitivity adjustment on mechanical ventilator in addition to traditional chest physiotherapy. |
| Study Group C | Active comparator | Procedure: concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) techniqueStudy Group C (25 patients) will receive a concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique in addition to traditional chest physiotherapy. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients of both sexes with age ranges (50-60) years old.
- Patients will be referred with acute respiratory failure (ARF) inside ICU.
- All patients are intubated and mechanically ventilated with assisted control (pressure or volume) or pressure support modes for 24-48 hours.
- All patients with positive end expiratory pressure (PEEP) don't exceed 10 cmH2o.
- All patients are hemodynamically stable; temperature (36.2-37.5) C, Heart rate < 140 /min, Blood pressure (systolic: <180mmHg and diastolic <100 mmHg), Respiratory rate < 35/min and oxygen saturation >90%
Key exclusion criteria (11 listed)
- Fraction of inspired oxygen (fio2)>0.6 and SPO2 < 85% to avoid further hypoxia and respiratory distress.
- Positive end expiratory pressure (PEEP) > 10 cmH2O to avoid barotrauma.
- Severe pulmonary condition; acute pulmonary embolism, undrained pneumothorax.
- Unstable hemodynamic condition as defined by heart rate more than 140 beats/min, systolic blood pressure >180 mmHg or Low blood pressure < 80 mmHg and respiratory rate is exceeding 35 breaths/min.
- Patients who develop any cardiac condition during the course of treatment; acute myocardial infarction or cardiac arrhythmia.
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 |
|---|---|---|
| Manual diaphragmatic facilitation (PNF) techniqueAlso: Diaphragmatic PNFDiaphragmatic PNF is a facilitator technique used to improve chest expansion, increase epigastric excursion, promote breathing frequency and depth, by applying external proprioceptive tactile stimuli over diaphragm. The therapist places the thumbs toward the xiphoid process and the fingers along the costal margins of the lower ribs and pushing deep to stimulate the diaphragm During inspiration, the patient will be instructed "take a deep breath breathe in" and the therapist assists the movement to promote the subject's respiratory pattern in downward movement. At the maximum inspiration, therapist will say "hold your breath for 5 seconds". The therapist gives mild resistance to the inferior movement of the contracting diaphragm during inspiration while pushing diaphragm superiorly. During expiration, therapist says "breathe out" and pushed under lower ribs on both sides upward to assist the discharge of air remaining in the lungs. | Procedure or surgery | Study Group A |
| Trigger sensitivity adjustment on mechanical ventilationAlso: Trigger sensitivityThe pressure trigger sensitivity will be adjusted to 20% of the first recorded MIP at the start of training by decreasing trigger sensitivity towards negative pressure. 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 reaches 30 min. If a patient tolerates 30 min of IMT, The next session will be performed with increasing negative pressure of the trigger sensitivity by 10% of the initial MIP. The maximal acceptable intensity is 40% of MIP, Patients who can't tolerate IMT with 20% of MIP for 5 min will be trained with 10% of MIP | Procedure or surgery | Study Group B |
| concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) techniqueDiaphragmatic PNF technique will be applied synchronously in the same time, on each breath with trigger sensitivity adjustment on mechanical ventilation in same manner as discussed before | Procedure or surgery | Study Group C |
Primary outcome
Blood gases analysis
Time frame: Blood gases will be analyzed and recorded for all patients pre and post the treatment program duration 5 up to 7 days
Blood gases analyzer(SIEMENS RAPIDLAB 1265, manufactured in 2008) is used in every clinical diagnosis lab or critical care facility to measure blood gases (PH, pco2 and po2), electrolytes, and metabolites parameters from whole blood samples. An arterial blood catheter (cannula) was inserted into the radial artery to draw blood sample of (2 to 3) ml, in a (3 to 5) ml plastic airtight syringe fitted with a small bore needled and filled with heparin. The standard values: PH 7.35-7.45, PaCO2 35-45, PaO2 60-100, SPO2 95-100% and PaO2/FiO2 ratio >300.
Oxygenation Index (OI)
Time frame: OI will be recorded for three study groups pre and post the treatment program duration 5 up to 7 days
OI is recognized as the primary indicator for respiratory disease severity stratification in mechanically ventilated patients to assess the intensity of ventilatory support that needed to maintain adequate oxygenation and predict outcomes in patients with ARF. OI = (FiO2 x MAP) / PaO2 OI normally, <15 as the lower the OI the better the outcome: as the oxygenation of the patient improves, they can achieve a higher PaO2 at a lower FiO2.
Maximum Inspiratory Pressure (MIP)
Time frame: MIP will be measured digitally from the MV for all patients pre and post the treatment program duration 5 up to 7 days.
MIP also known as negative inspiratory force (NIF); the maximum negative pressure generated for at least 1 second during maximal inspiratory effort against occluded airway that estimated inspiratory muscle strength mainly diaphragm. PImax has been widely used to quantify respiratory muscle weakness. PImax values of more than -25 cmH2O was considered as an index to predict weaning success. To obtain reliable results, the maneuver will be performed three times, with a 1-min interval between readings. The highest value was chosen as PImax.
Rapid shallow breathing index (RSBI)
Time frame: RSBI was measured for all patients pre and post the treatment program duration 5 up to 7 days
RSBI is an index used to predict weaning from MV, defined as the ratio of respiratory frequency to tidal volume (f/VT). People on MV who cannot tolerate independent breathing tend to breath rapidly (high frequency) and shallowly (low tidal volume) and will therefore have a high RSBI. RSBI<105 is reported to be the most accurate predictor of successful patient extubation. ventilator mode was switched on CPAP with zero pressure support to divide f by Vt to obtain RSBI (f/Vt).
Weaning Success Rate
Time frame: it will be recorded for three study groups post the treatment program duration 5 up to 7 days
Weaning success is defined as spontaneous breathing without mechanical support for at least 48 hours. Weaning success rate (a proportion of successfully weaned patients to total number of patients receiving a treatment program)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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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. This study is not recruiting at the moment.
Hany E Obaya, PHD study chair
Cairo University
El sayed E El sayed, PHD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual diaphragmatic facilitation (PNF) technique, Trigger sensitivity adjustment on mechanical ventilation and concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique in people with Acute Respiratory Failure and Mechanically Ventilated Patients, run by Cairo 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 31 Aug 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood gases analysis (time frame: Blood gases will be analyzed and recorded for all patients pre and post the treatment program duration 5 up to 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2023.