Clinical trial NCT05480371: Cough Assist Device in Mechanically Ventilated Patients
Official title: Role of Cough Assist Device in Mechanically Ventilated Patients in Respiratory Intensive Care Unit : Assiut University Experience
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanically Ventilated Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 .

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

Primary outcomes:
measure: Assess effects of MIE on Volume of Secretions
timeFrame: 1 year
measure: Assess effects of MIE on respiratory rate
timeFrame: 1 year
measure: Assess effects of MIE on tidal volume
timeFrame: 1 year
measure: Assess effects of MIE on minute ventilation
timeFrame: 1 year
measure: Assess effects of MIE on Oxygen saturation
timeFrame: 1 year
measure: Assess effects of MIE on heart rate
timeFrame: 1 year
measure: Assess effects of MIE on blood pressur
timeFrame: 1 year
Secondary outcomes:
measure: Assess safety of Mechanical insufflation-exsufflation
timeFrame: 1 year
Other outcomes:
measure: Compare the effects and safety of MIE versus Endotracheal Suctioning
timeFrame: 1 year
Locations:
Study officials:
affiliation: Assiut University
name: Reham Mohammed Elmorshedy
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Marawan NaerELdin Mohammed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fahy JV, Dickey BF. Airway mucus function and dysfunction. N Engl J Med. 2010 Dec 2;363(23):2233-47. doi: 10.1056/NEJMra0910061. No abstract available.
citation: American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64.
citation: McCool FD. Global physiology and pathophysiology of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):48S-53S. doi: 10.1378/chest.129.1_suppl.48S.
citation: Rothaar RC, Epstein SK. Extubation failure: magnitude of the problem, impact on outcomes, and prevention. Curr Opin Crit Care. 2003 Feb;9(1):59-66. doi: 10.1097/00075198-200302000-00011.
citation: Sole ML, Bennett M, Ashworth S. Clinical Indicators for Endotracheal Suctioning in Adult Patients Receiving Mechanical Ventilation. Am J Crit Care. 2015 Jul;24(4):318-24; quiz 325. doi: 10.4037/ajcc2015794.
citation: Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17.
citation: Chatwin M, Ross E, Hart N, Nickol AH, Polkey MI, Simonds AK. Cough augmentation with mechanical insufflation/exsufflation in patients with neuromuscular weakness. Eur Respir J. 2003 Mar;21(3):502-8. doi: 10.1183/09031936.03.00048102.
citation: Vianello A, Corrado A, Arcaro G, Gallan F, Ori C, Minuzzo M, Bevilacqua M. Mechanical insufflation-exsufflation improves outcomes for neuromuscular disease patients with respiratory tract infections. Am J Phys Med Rehabil. 2005 Feb;84(2):83-8; discussion 89-91. doi: 10.1097/01.phm.0000151941.97266.96.
citation: Chatwin M, Toussaint M, Goncalves MR, Sheers N, Mellies U, Gonzales-Bermejo J, Sancho J, Fauroux B, Andersen T, Hov B, Nygren-Bonnier M, Lacombe M, Pernet K, Kampelmacher M, Devaux C, Kinnett K, Sheehan D, Rao F, Villanova M, Berlowitz D, Morrow BM. Airway clearance techniques in neuromuscular disorders: A state of the art review. Respir Med. 2018 Mar;136:98-110. doi: 10.1016/j.rmed.2018.01.012. Epub 2018 Feb 6.