Concurrent Trigger Sensitivity Adjustment And Diaphragmatic Facilitation On Weaning From Mechanic… (NCT05387720) | Clinical Trial Compass
CompletedNot Applicable
Concurrent Trigger Sensitivity Adjustment And Diaphragmatic Facilitation On Weaning From Mechanical Ventilation
Egypt75 participantsStarted 2020-12-01
Plain-language 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. 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.
Who can participate
Age range
50 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Active lung infection like tuberculosis.
* Chest trauma such as rib fracture, flail chest, thoracic vertebra fracture or chest burns.
* Spin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood gases analysis
Timeframe: Blood gases will be analyzed and recorded for all patients pre and post the treatment program duration 5 up to 7 days
2
Oxygenation Index (OI)
Timeframe: OI will be recorded for three study groups pre and post the treatment program duration 5 up to 7 days
3
Maximum Inspiratory Pressure (MIP)
Timeframe: MIP will be measured digitally from the MV for all patients pre and post the treatment program duration 5 up to 7 days.
4
Rapid shallow breathing index (RSBI)
Timeframe: RSBI was measured for all patients pre and post the treatment program duration 5 up to 7 days
5
Weaning Success Rate
Timeframe: it will be recorded for three study groups post the treatment program duration 5 up to 7 days