Cough Assist Device in Mechanically Ventilated Patients

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Mechanically Ventilated Patients
• Intervention / Treatment: Device: Conventional tracheal suctioning; Device: Mechanical insufflation/exsufflation

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hadeer sayed khalifa; Phone Number: 01007787691; Email: hadeer_sayed2011@yahoo.com.au
• Study Contact Backup: Name: maha mohamed ElKholy; Phone Number: 0109656205; Email: maha_elkholy@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional endotracheal 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	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.
Experimental: 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	Device: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the effects and safety of MIE versus Endotracheal Suctioning	Comparison accoring to number of complications with each procedure	1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Reham Mohammed Elmorshedy, Assiut University; Principal Investigator: Marawan NaerELdin Mohammed, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: cough assist device

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No