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

Not Applicable

Not yet recruiting

• Conditions: Ventilated Patients; Acute Stroke Intervention

• Registration Number: NCT07003867
• Lead Sponsor: Al-Zaytoonah University of Jordan

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

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Study Start: 2025-06-10
• Primary Completion: 2025-08-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulmonary compliance ( mL/cmH2O )	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)

Secondary Outcome Measures

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