Cough Assist Device in Mechanically Ventilated Patients

Mechanically Ventilated Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05480371
• Other study ID #: cough assist device
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 2023

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: hadeer sayed khalifa
• Phone: 01007787691
• Email: hadeer_sayed2011[@]yahoo.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanically Ventilated Patients

Intervention

Device:
• Conventional tracheal suctioning
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.
• Mechanical insufflation/exsufflation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

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. — View 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. — View Citation

Chatwin M, Toussaint M, Gonçalves 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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the effects and safety of MIE versus Endotracheal Suctioning	Comparison accoring to number of complications with each procedure	1 year
Primary	Assess effects of MIE on Volume of Secretions	Volume of Secretions measured in ml	1 year
Primary	Assess effects of MIE on respiratory rate	Respiratory rate measured by breaths per minute	1 year
Primary	Assess effects of MIE on tidal volume	Tidal volume measured in cubic centimeter	1 year
Primary	Assess effects of MIE on minute ventilation		1 year
Primary	Assess effects of MIE on Oxygen saturation		1 year
Primary	Assess effects of MIE on heart rate	Heart rate measured by beats per minute	1 year
Primary	Assess effects of MIE on blood pressur	Blood pressure measuered in mmHg	1 year
Secondary	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