Ventilated PatientsNCT07003867
Ventilator Inspiratory Trigger Sensitivity Adjustment Versus Threshold Device Training on Pulmonary Functions in Acute Stroke Patients
A study testing Ventilator inspiratory trigger sensitivity adjustment , threshold device training in people with Ventilated Patients and Acute Stroke Intervention, run by Al-Zaytoonah University of Jordan at 1 site in Egypt.
Trial summary
Neurological dysfunction is a common condition necessitating prolonged mechanical ventilation (PMV). Among patients with acute neurological diseases, 17% to 33% are intubated and mechanically ventilated for respiratory failure. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Ventilated Patients, Acute Stroke Intervention
- What is being tested?
- Ventilator inspiratory trigger sensitivity adjustment , threshold device training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2025to 15 Sep 2025
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 40-60 years.
- Diagnosed with acute stroke patients.
- Body mass index (BMI) 18:35 kg/m².
- conscious oriented patients with Glasgow coma score ≥ 13.
- PH>7.25 and arterial oxygen saturation >90%
Who cannot join
- Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure, angina.
- Severe breathlessness when spontaneously breathing.
- Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training.
- Spinal cord injuries.
- Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
- Patients on heavy sedation and respiratory muscle paralysis
Trial locations and contacts
1 site in 1 country.
About this study
Neurological dysfunction is a common condition necessitating prolonged mechanical ventilation (PMV). Among patients with acute neurological diseases, 17% to 33% are intubated and mechanically ventilated for respiratory failure. Patients with acute neurological diseases requiring MV generally have adverse outcomes with a hospital mortality rate among patients with such diseases has been reported to be in the range of 16-33%. Inspiratory muscle weakness is common in patients receiving mechanical ventilation, especially patients with prolonged duration of mechanical ventilation. Inspiratory muscle training could limit or reverse these unhelpful squeal and facilitate more rapid and successful weaning.Hence, the importance of physical therapy emerged in helping patients to be weaned from ventilators by using various methods to strengthen the respiratory muscles in different ways.
Read the detailed description
Mechanical ventilation (MV) is a life-saving intervention used worldwide in an estimated 15 million patients annually. Although70% of patients in intensive care units wean without difficulty on the first attempt, approximately 30% require prolonged weaning. Prolonged mechanical ventilation is associated with an increased risk of death ,poor long-term functional outcomes, and markedly higher healthcare costsMechanical Ventilation (MV) is used to restore or enhance pulmonary gas exchange in patients who are unable to maintain adequate alveolar ventilation. Conditions that necessitate the use of MV include but are not restricted to neuromuscular diseases, respiratory failure secondary to chronic obstructive lung disease and following surgery with general anesthesia . A high proportion of patients who require prolonged MV for more than 48 hours do not survive for 1 year, and those who survive have a significantly reduced functional status and quality of life . Prolonged MV has a detrimental impact on the diaphragm, and this has been termed as Ventilator-Induced Diaphragmatic Dysfunction (VIDD ).Inspiratory muscle training is a type of training in which the patient inhales against resistive loads or pressure threshold-loads while the expiration is unloaded, that applies a load to the diaphragm and accessory inspiratory muscles to increase their strength and endurance .The trigger phase corresponds to the process in which the patient's spontaneous breathing triggers the ventilator to work. The inhalation phase corresponds to the process in which PAW rises to the plateau pressure while maintaining pressure support
- Conditions
- Ventilated Patients, Acute Stroke Intervention
- Being tested
- Ventilator inspiratory trigger sensitivity adjustment , threshold device training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator inspiratory trigger sensitivity adjustment , threshold device trainingOther
Ventilator inspiratory trigger sensitivity adjustment threshold device training
| Study group | Role | What they receive |
|---|---|---|
| Control group ( threshold inspiratory muscle training ) | Active comparator | Not described Receives: Other: Ventilator inspiratory trigger sensitivity adjustment , threshold device training |
| Experimental group ( Adjustment of ventilator trigger sensitivity ) | Experimental | Not described Receives: Other: Ventilator inspiratory trigger sensitivity adjustment , threshold device training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary compliance ( mL/cmH2O )
A measure of the lung expandability, which is important in ideal respiratory system function. It refers to the ability of the lungs to stretch and expand. Lung compliance can be calculated by dividing volume by pressure (C = V/P), Pulmonary compliance was assessed daily in all mechanically ventilated patients using data obtained directly from the ventilator system (CARESCAPE -R860/USA)
Measured: pre and post 1 week
Secondary outcomes (4)
Paco2 (mmHg)
partial pressure of carbon dioxide in arterial blood , using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)
Measured: pre and post 1 week of intervention
PaO2 ( mmHg )
partial pressure of oxygen in arterial blood ,using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)
Measured: pre and post 1 week of intervention
HCO3 ( mEq/L )
Refers to bicarbonate, a key component of the blood's acid-base balance ,using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)
Measured: Pre and post 1 week of intervention
pH
Refers to the acidity or alkalinity of the blood ,using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)
Measured: Pre and post 1 week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start10 Jun 2025
- Primary completion15 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilated PatientsStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Saied Zidan, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003867
- Sponsor's protocol ID
- IRB # 1/4/2024-2025
- Status last verified
- Nov 2025
- First submitted
- 23 May 2025
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator Inspiratory Trigger Sensitivity Adjustment Versus Threshold Device Training on Pulmonary Functions in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT07003867
- Acronym / sponsor ID
- IRB # 1/4/2024-2025
- Conditions
- Ventilated Patients, Acute Stroke Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 4 Jun 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.
Neurological dysfunction is a common condition necessitating prolonged mechanical ventilation (PMV). Among patients with acute neurological diseases, 17% to 33% are intubated and mechanically ventilated for respiratory failure. Patients with acute neurological diseases requiring MV generally have adverse outcomes with a hospital mortality rate among patients with such diseases has been reported to be in the range of 16-33%. Inspiratory muscle weakness is common in patients receiving mechanical ventilation, especially patients with prolonged duration of mechanical ventilation. Inspiratory muscle training could limit or reverse these unhelpful squeal and facilitate more rapid and successful weaning.Hence, the importance of physical therapy emerged in helping patients to be weaned from ventilators by using various methods to strengthen the respiratory muscles in different ways.
Detailed description
Mechanical ventilation (MV) is a life-saving intervention used worldwide in an estimated 15 million patients annually. Although70% of patients in intensive care units wean without difficulty on the first attempt, approximately 30% require prolonged weaning. Prolonged mechanical ventilation is associated with an increased risk of death ,poor long-term functional outcomes, and markedly higher healthcare costsMechanical Ventilation (MV) is used to restore or enhance pulmonary gas exchange in patients who are unable to maintain adequate alveolar ventilation. Conditions that necessitate the use of MV include but are not restricted to neuromuscular diseases, respiratory failure secondary to chronic obstructive lung disease and following surgery with general anesthesia . A high proportion of patients who require prolonged MV for more than 48 hours do not survive for 1 year, and those who survive have a significantly reduced functional status and quality of life . Prolonged MV has a detrimental impact on the diaphragm, and this has been termed as Ventilator-Induced Diaphragmatic Dysfunction (VIDD ).Inspiratory muscle training is a type of training in which the patient inhales against resistive loads or pressure threshold-loads while the expiration is unloaded, that applies a load to the diaphragm and accessory inspiratory muscles to increase their strength and endurance .The trigger phase corresponds to the process in which the patient's spontaneous breathing triggers the ventilator to work. The inhalation phase corresponds to the process in which PAW rises to the plateau pressure while maintaining pressure support
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group ( threshold inspiratory muscle training ) | Active comparator | Other: Ventilator inspiratory trigger sensitivity adjustment , threshold device training |
| Experimental group ( Adjustment of ventilator trigger sensitivity ) | Experimental | Other: Ventilator inspiratory trigger sensitivity adjustment , threshold device training |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 40-60 years.
- Diagnosed with acute stroke patients.
- Body mass index (BMI) 18:35 kg/m².
- conscious oriented patients with Glasgow coma score ≥ 13.
- PH>7.25 and arterial oxygen saturation >90%
Key exclusion criteria (6 listed)
- Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure, angina.
- Severe breathlessness when spontaneously breathing.
- Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training.
- Spinal cord injuries.
- Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
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 |
|---|---|---|
| Ventilator inspiratory trigger sensitivity adjustment , threshold device trainingVentilator inspiratory trigger sensitivity adjustment threshold device training | Other | Control group ( threshold inspiratory muscle training ), Experimental group ( Adjustment of ventilator trigger sensitivity ) |
Primary outcome
Pulmonary compliance ( mL/cmH2O )
Time frame: pre and post 1 week
A measure of the lung expandability, which is important in ideal respiratory system function. It refers to the ability of the lungs to stretch and expand. Lung compliance can be calculated by dividing volume by pressure (C = V/P), Pulmonary compliance was assessed daily in all mechanically ventilated patients using data obtained directly from the ventilator system (CARESCAPE -R860/USA)
4 secondary outcomes
Paco2 (mmHg)
Time frame: pre and post 1 week of intervention
PaO2 ( mmHg )
Time frame: pre and post 1 week of intervention
HCO3 ( mEq/L )
Time frame: Pre and post 1 week of intervention
pH
Time frame: Pre and post 1 week of intervention
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 19 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator inspiratory trigger sensitivity adjustment , threshold device training in people with Ventilated Patients and Acute Stroke Intervention, run by Al-Zaytoonah University of Jordan 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 5 inclusion and 6 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 19 Nov 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.
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?
Pulmonary compliance ( mL/cmH2O ) (time frame: pre and post 1 week). 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 19 Nov 2025.