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Clinical Trials/NCT05480371
NCT05480371
Unknown
Not Applicable

Role of Cough Assist Device in Mechanically Ventilated Patients in Respiratory Intensive Care Unit : Assiut University Experience

Assiut University0 sites200 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanically Ventilated Patients
Sponsor
Assiut University
Enrollment
200
Primary Endpoint
Assess effects of MIE on Volume of Secretions
Last Updated
3 years ago

Overview

Brief Summary

Aspiration of respiratory secretions is a frequently needed procedure in intubated patients .

Cough is an important defence mechanism to clear mucus from the upper and lower airways . The presence of an endotracheal tube impairs the ability to cough.There are a number of techniques to mobilise sputum and optimise airway clearance for invasively ventilated patients. Endotracheal suctioning is the most common intervention used to remove retained airway secretions from within the endotracheal tube, trachea and upper airways .Mechanical insufflation-exsufflation (MI-E) aids sputum clearance from upper and lower airways. This technique augments inspiratory and expiratory flows to improve sputum mobilisation, through the application of rapidly alternating positive and negative pressure, which approximates a normal cough

Detailed Description

Critically ill patients under invasive ventilation are at risk for sputum retention . Aspiration of respiratory secretions is a frequently needed procedure in intubated patients . Cough is an important defence mechanism to clear mucus from the upper and lower airways . The presence of an endotracheal tube impairs the ability to cough. This prevents the enhancement of cough velocity . Furthermore, critically ill patients frequently have an impaired or no cough reflex due to depressed levels of consciousness, sedation, muscle weakness or muscle paralysis. Sputum retention, resulting from an inability to cough effectively, is one cause of extubation failure which in turn is associated with increased mortality. There are a number of techniques to mobilise sputum and optimise airway clearance for invasively ventilated patients. Endotracheal suctioning is the most common intervention used to remove retained airway secretions from within the endotracheal tube, trachea and upper airways . Endotracheal suctioning though is not effective for clearing secretions from the lower airways . New technologies and advanced methods have been developed to increase the effectiveness of mucus clearance in patients with acute respiratory failure, including mechanical insufflation-exsufflation devices. This technique has been described as an effective aid for mucus clearance in patients with chronic muscle weakness or neuromuscular disease. Mechanical insufflation-exsufflation (MI-E) aids sputum clearance from upper and lower airways. This technique augments inspiratory and expiratory flows to improve sputum mobilisation, through the application of rapidly alternating positive and negative pressure, which approximates a normal cough .

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
August 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hadeer Sayed Khalifa

Principal Investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Adult patients of both sexes on mechanical ventilation in RICU with any respiratory disease
  • Mechanically ventilated Patients without facial trauma
  • Mechanically ventilated Patients hemodynamically stable

Exclusion Criteria

  • Patients diagnosed with barotrauma
  • Patients diagnosed with pneumothorax
  • History of bullous emphysema Known susceptibility to pneumothorax or pneumo-mediastinum

Outcomes

Primary Outcomes

Assess effects of MIE on Volume of Secretions

Time Frame: 1 year

Volume of Secretions measured in ml

Assess effects of MIE on respiratory rate

Time Frame: 1 year

Respiratory rate measured by breaths per minute

Assess effects of MIE on tidal volume

Time Frame: 1 year

Tidal volume measured in cubic centimeter

Assess effects of MIE on minute ventilation

Time Frame: 1 year

Assess effects of MIE on Oxygen saturation

Time Frame: 1 year

Assess effects of MIE on heart rate

Time Frame: 1 year

Heart rate measured by beats per minute

Assess effects of MIE on blood pressur

Time Frame: 1 year

Blood pressure measuered in mmHg

Secondary Outcomes

  • Assess safety of Mechanical insufflation-exsufflation(1 year)

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