Cough Assist Device in Mechanically Ventilated Patients

NCT05480371 | Unknown

• 1 other identifier: cough assist device
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Mechanically Ventilated Patients

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Assess safety of Mechanical insufflation-exsufflation

  1 year

Other Outcomes (1)

• Compare the effects and safety of MIE versus Endotracheal Suctioning

  1 year

Study Arms (2)

Conventional endotracheal suctioning

ACTIVE COMPARATOR

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

mechanical insufflation exsufflation

EXPERIMENTAL

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

Interventions

Conventional tracheal suctioning DEVICE

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.

Conventional endotracheal suctioning

Mechanical insufflation/exsufflation DEVICE

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.

mechanical insufflation exsufflation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients diagnosed with barotrauma
• Patients diagnosed with pneumothorax
• History of bullous emphysema Known susceptibility to pneumothorax or pneumo-mediastinum

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 21121836 BACKGROUND

• 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.

  PMID: 20507660 BACKGROUND

• 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.

  PMID: 16428691 BACKGROUND

• 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.

  PMID: 12548031 BACKGROUND

• 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.

  PMID: 26134331 BACKGROUND

• 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.

  PMID: 30018175 BACKGROUND

• 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.

  PMID: 12662009 BACKGROUND

• 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.

  PMID: 15668554 BACKGROUND

• 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.

  PMID: 29501255 BACKGROUND

Study Officials

• Reham Mohammed Elmorshedy

  Assiut University

  PRINCIPAL INVESTIGATOR

• Marawan NaerELdin Mohammed

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hadeer sayed khalifa

CONTACT

01007787691; hadeer_sayed2011@yahoo.com.au

maha mohamed ElKholy

CONTACT

0109656205; maha_elkholy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 29, 2022
• Study Start: August 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 1, 2023
• Last Updated: July 29, 2022

Record last verified: 2022-07