Actively Recruiting
Effect of Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases in Mechanically Ventilated Patients, a Randomized Clinical Trial
Led by Cairo University · Updated on 2024-12-17
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two methods—ventilator trigger sensitivity adjustment and threshold inspiratory muscle training—and their effects on arterial blood gases in patients who are mechanically ventilated. It focuses on patients with Guillain-Barre Syndrome who have difficulty weaning from mechanical ventilation, a process that can lead to complications like failed extubations, increased hospital stays, and higher morbidity and mortality. Participants will be assigned to one of three groups: training inspiratory muscles using a threshold inspiratory muscle trainer, training using ventilator pressure settings, or receiving only the standard medical treatment program. These interventions are designed to help improve breathing and support weaning from mechanical ventilation. The study includes a treatment period averaging two weeks. During the study, patients will undergo various assessments before and immediately after the intervention, continuing through the two-week period. These include measurements of blood pH, oxygen and carbon dioxide levels, bicarbonate, breathing patterns, sedation and agitation scores, respiratory rate, and ventilation volume. The study also monitors weaning success rate and other clinical scales to evaluate progress and safety throughout participation.
CONDITIONS
Brief Title
Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Difficult to wean Guillain-Barre patients who have been on mechanical ventilation for at least 48 hours
- Age over 18 years
- Both sexes are included
- Ventilator mode is pressure support with FiO2 of 0.5 or less, PEEP below 8-10 cm H2O, and respiratory rate under 25
- Conscious and oriented with Glasgow coma score 13 or higher
- Alertness adjusted to Riker Sedation Agitation Score of 4
- pH greater than 7.25 and arterial oxygen saturation above 90%
- Cardiovascular stability
- Maximal inspiratory pressure between 15 and 30 cm H2O and able to trigger spontaneous breaths on ventilator
You will not qualify if you...
- Persistent hemodynamic instability such as life-threatening arrhythmias or acute heart failure
- Severe breathlessness when breathing spontaneously
- Progressive neuromuscular diseases that interfere with inspiratory muscle training
- Spinal cord injury
- Skeletal problems like scoliosis, flail chest, or spinal instrumentation affecting chest wall movement
- Patients on heavy sedation or respiratory muscle paralysis
- High peak airway pressure indicating barotrauma
- Body mass index of 40 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive inspiratory muscle training using either threshold inspiratory muscle trainer or ventilator pressure setting techniques, or continue with traditional treatment to support the weaning process from mechanical ventilation.
Visits throughout the 2-week treatment period
Trial Site Locations
Total: 1 location
1
Kasr Al Ainy School of Medicine
Cairo, Egypt
Actively Recruiting
Research Team
E
Elmasry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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