Skip to content

Ventilator Inspiratory Trigger Sensitivity Adjustment Versus Threshold Device Training on Pulmonary Functions in Acute Stroke Patients

Ventilator Inspiratory Trigger Sensitivity Adjustment Versus Threshold Device Training on Pulmonary Functions in Acute Stroke Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07003867
Enrollment
40
Registered
2025-06-04
Start date
2025-06-10
Completion date
2025-09-15
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke Intervention, Ventilated Patients

Brief 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. 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

Interventions

OTHERVentilator inspiratory trigger sensitivity adjustment , threshold device training

Ventilator inspiratory trigger sensitivity adjustment threshold device training

Sponsors

Al-Zaytoonah University of Jordan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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%

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary compliance ( mL/cmH2O )pre and post 1 weekA 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)

Secondary

MeasureTime frameDescription
Paco2 (mmHg)pre and post 1 week of interventionpartial pressure of carbon dioxide in arterial blood , using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)
PaO2 ( mmHg )pre and post 1 week of interventionpartial pressure of oxygen in arterial blood ,using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)
HCO3 ( mEq/L )Pre and post 1 week of interventionRefers to bicarbonate, a key component of the blood's acid-base balance ,using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)
pHPre and post 1 week of interventionRefers to the acidity or alkalinity of the blood ,using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026