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

NCT ID: NCT07003867

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-10
• Study Completion Date: 2025-09-15

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

Conditions

Ventilated Patients; Acute Stroke Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group ( threshold inspiratory muscle training )

Group Type: ACTIVE_COMPARATOR

Ventilator inspiratory trigger sensitivity adjustment , threshold device training

Intervention Type: OTHER

Ventilator inspiratory trigger sensitivity adjustment threshold device training

Experimental group ( Adjustment of ventilator trigger sensitivity )

Group Type: EXPERIMENTAL

Ventilator inspiratory trigger sensitivity adjustment , threshold device training

Intervention Type: OTHER

Ventilator inspiratory trigger sensitivity adjustment threshold device training

Interventions

Ventilator inspiratory trigger sensitivity adjustment , threshold device training

Ventilator inspiratory trigger sensitivity adjustment threshold device training

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Zaytoonah University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Saied Zidan

Assistant prof dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mohamed Saied Zidan

Cairo, , Egypt

Countries

Egypt

Other Identifiers

IRB # 1/4/2024-2025

Identifier Type: -

Identifier Source: org_study_id