Cough Assist Device in Mechanically Ventilated Patients

Assiut University

Status: Not yet enrolling

Conditions: Mechanically Ventilated Patients

Treatments: Device: Mechanical insufflation/exsufflation; Device: Conventional tracheal suctioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05480371

cough assist device

Details and patient eligibility

About

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

Full 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 .

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Conventional endotracheal suctioning

Active Comparator group

Description:

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

Treatment:

Device: Conventional tracheal suctioning

mechanical insufflation exsufflation

Experimental group

Description:

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

Treatment:

Device: Mechanical insufflation/exsufflation