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

NCT07003867 | Completed

• 1 other identifier: IRB # 1/4/2024-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilated Patients; Acute Stroke Intervention

Outcome Measures

Primary Outcomes (1)

• Pulmonary compliance ( mL/cmH2O )

  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)

  pre and post 1 week

Secondary Outcomes (4)

• Paco2 (mmHg)

  pre and post 1 week of intervention

• PaO2 ( mmHg )

  pre and post 1 week of intervention

• HCO3 ( mEq/L )

  Pre and post 1 week of intervention

• pH

  Pre and post 1 week of intervention

Study Arms (2)

Control group ( threshold inspiratory muscle training )

ACTIVE COMPARATOR

Other: Ventilator inspiratory trigger sensitivity adjustment , threshold device training

Experimental group ( Adjustment of ventilator trigger sensitivity )

EXPERIMENTAL

Other: Ventilator inspiratory trigger sensitivity adjustment , threshold device training

Interventions

Ventilator inspiratory trigger sensitivity adjustment , threshold device training OTHER

Ventilator inspiratory trigger sensitivity adjustment threshold device training

Control group ( threshold inspiratory muscle training ); Experimental group ( Adjustment of ventilator trigger sensitivity )

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Zaytoonah University of Jordan: lead

Study Sites (1)

Mohamed Saied Zidan

Cairo, 11571, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant prof dr

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 4, 2025
• Study Start: June 10, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

EG (1)