Cough Assist Device in Mechanically Ventilated Patients

Not Applicable

• Conditions: Mechanically Ventilated Patients

• Registration Number: NCT05480371
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-27
• Last Update Submitted: 2022-07-27
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Study Start: 2022-08-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess effects of MIE on Volume of Secretions	1 year	Volume of Secretions measured in ml
Assess effects of MIE on respiratory rate	1 year	Respiratory rate measured by breaths per minute
Assess effects of MIE on tidal volume	1 year	Tidal volume measured in cubic centimeter
Assess effects of MIE on minute ventilation	1 year
Assess effects of MIE on Oxygen saturation	1 year
Assess effects of MIE on heart rate	1 year	Heart rate measured by beats per minute
Assess effects of MIE on blood pressur	1 year	Blood pressure measuered in mmHg

Secondary Outcome Measures

Name	Time	Method
Assess safety of Mechanical insufflation-exsufflation	1 year	assess safety according to number of complications e.g (hypotension, arrythmias, oxygen desaturaion, pneumothorax) and number of participants with complications