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Completed

NCT Number: NCT07003867

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

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Saied Zidan

Cairo, 11571, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventilator inspiratory trigger sensitivity adjustment , threshold device training

Other

Ventilator inspiratory trigger sensitivity adjustment threshold device training

Primary outcomes

  1. Pulmonary compliance ( mL/cmH2O )

    Time frame: 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 outcomes

  1. Paco2 (mmHg)

    Time frame: pre and post 1 week of intervention

    partial pressure of carbon dioxide in arterial blood , using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)

  2. PaO2 ( mmHg )

    Time frame: pre and post 1 week of intervention

    partial pressure of oxygen in arterial blood ,using Blood Gas analyzer:(Abbott Laboratories Pharmaceutical Company, Singapore)

  3. HCO3 ( mEq/L )

    Time frame: 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)

  4. pH

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Al-Zaytoonah University of Jordan

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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