Cough Assist Device in Mechanically Ventilated Patients

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Mechanically Ventilated Patients

Intervention / Treatment
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* Device: Conventional tracheal suctioning
* Device: Mechanical insufflation/exsufflation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional endotracheal suctioning<br>Tracheal suctioning will be performed following the American Association for Respiratory Care recommendations: closed suction system, suction catheter with maximal internal-to-external diameter ratio of 0.5, delivery of 100% oxygen 30 s immediately before and 1 min after the procedure, duration of 15 s, and vacuum pressure of ±150 mmHg | Device: Conventional tracheal suctioning<br>* Group 1 allocated to conventional tracheal suctioning,all patiemts will be followed up until discharge from ICU or death Tracheal suctioning will be performed following the American Association for Respiratory Care recommendations.<br>|
| Experimental: mechanical insufflation exsufflation<br>The mechanical insufflation-exsufflation will be performed with the which will be applied 5 times in 5cough cycles in automatic mode, with insufflation and exsufflation pressures of + 40/-40 cmH2O, respectively. The duration of each phase was 3 s, without pause, and tracheal suctioning will be performed at the end of the procedure. Hyperoxygenation (100% O2) will be performed for 1 min before applying each technique and a 20 s interval will be allowed between repetitions. The secretion collected after each procedure will be stored in a disposable bronchial secretion collector for later weighing | Device: Mechanical insufflation/exsufflation<br>* Group 2 will be allocated to mechanical insufflation-exsufflation which will be performed with the which will be applied 5 times in 5cough cycles in automatic mode, with insufflation and exsufflation pressures of + 40/-40 cmH2O, respectively. The duration of each phase was 3 s, without pause. Hyperoxygenation (100% O2) will be performed for 1 min before applying each technique and a 20 s interval will be allowed between repetitions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess effects of MIE on Volume of Secretions | Volume of Secretions measured in ml | 1 year | 
| Assess effects of MIE on respiratory rate | Respiratory rate measured by breaths per minute | 1 year | 
| Assess effects of MIE on tidal volume | Tidal volume measured in cubic centimeter | 1 year | 
| 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 | Heart rate measured by beats per minute | 1 year | 
| Assess effects of MIE on blood pressur | Blood pressure measuered in mmHg | 1 year | 

Secondary Outcome Measures

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