Cough Assist Device in Mechanically Ventilated Patients
- Conditions
- Mechanically Ventilated Patients
- Interventions
- Device: Mechanical insufflation/exsufflationDevice: Conventional tracheal suctioning
- 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 .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
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
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
- Arm && Interventions
Group Intervention Description mechanical insufflation exsufflation Mechanical insufflation/exsufflation 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 Conventional endotracheal suctioning Conventional tracheal suctioning 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
- Primary Outcome Measures
Name Time Method 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
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
- 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