Tracheal Suctioning and Expiratory Pause in Bronchial Hygiene

Mechanical Ventilation Clinical Trial

Official title:

Effects of Combined Tracheal Suctioning and Expiratory Pause 5 or 10 Seconds: a Crossover Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579145
• Other study ID #: 51995621.7.0000.5327
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: November 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Luciane FG Martins, Master
• Phone: 55 51 81598395
• Email: lfgmartins[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized crossover clinical trial conducted in an Intensive Care Unit of the Hospital de Clinicas de Porto Alegre (HCPA) to compare the efficacy of the two techniques on the amount of aspirated pulmonary secretion and pulmonary mechanics: aspiration of the closed system following an expiratory pause with mechanical ventilator for 5 seconds (5-Second Expiratory Pause) and aspiration of the closed system following an expiratory pause with mechanical ventilator for 10 seconds (10-Second Expiratory Pause).

Description:

After randomization, all patients will be positioned in dorsal decubitus with the head elevated at 30 degrees and will be aspirated once with a closed suction system and with a vacuum of -40cm H2O. Hemodynamic and pulmonary parameters will be collected and recorded. One of the two techniques will be applied, according to randomization, and the outcomes measured. After two hours, hemodynamic and pulmonary parameters will be re-collected, and the second technique will be applied. The outcomes will be measured again.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients in 24 and 72 hours of mechanical ventilation.
• Patients with closed aspiration system.
• Patients hemodynamically stable (mean arterial blood pressure = 60 mmHg and with dose of Noradrenaline = 1µg/kg/minute).

Exclusion Criteria:

• Undrained pneumothorax and hemothorax.
• Subcutaneous emphysema.
• Patients who refuse to participate in the study.

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Other:
• 5-Second Expiratory Pause
Patients on mechanical ventilation for more than 24 hours will be randomized for the first technique to be applied. This technique consists of closed system aspiration and expiratory pause with mechanical ventilator for 5 seconds. After randomization and before the application of the technique, all patients will be positioned in supine position with the headboard elevated at 30 degrees and will be aspirated once with closed aspiration system and with vacuum of -40 cm H2O.
• 10-Second Expiratory Pause
Patients on mechanical ventilation for more than 24 hours will be randomized for the first technique to be applied. This technique consists of closed system aspiration and expiratory pause with mechanical ventilator for 10 seconds. After randomization and before the application of the technique, all patients will be positioned in supine position with the headboard elevated at 30 degrees and will be aspirated once with closed aspiration system and with vacuum of -40 cm H2O.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Luciane FG Martins	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (22)

Amato MB, Carvalho CR, Isola A, Vieira S, Rotman V, Moock M, José A, Franca S. [Mechanical ventilation in Acute Lung Injury (ALI)/Acute Respiratory Discomfort Syndrome (ARDS)]. J Bras Pneumol. 2007;33 Suppl 2S:S119-27. Portuguese. — View Citation

Azeredo CA, Bezerra RM. Manobras de Fisioterapia Respiratória na UTI.Editora SOS Pulmão/Cuca. Rio de Janeiro, 2004. Págs: 139.

Bhowmik A, Chahal K, Austin G, Chakravorty I. Improving mucociliary clearance in chronic obstructive pulmonary disease. Respir Med. 2009 Apr;103(4):496-502. doi: 10.1016/j.rmed.2008.10.014. Epub 2008 Dec 16. Review. — View Citation

Carlon GC, Fox SJ, Ackerman NJ. Evaluation of a closed-tracheal suction system. Crit Care Med. 1987 May;15(5):522-5. — View Citation

Ciesla ND. Chest physical therapy for patients in the intensive care unit. Phys Ther. 1996 Jun;76(6):609-25. Review. — View Citation

Craig KC, Benson MS, Pierson DI. Prevention of arterial oxygen desaturation during closed-airway endotracheal suction: effect of ventilator mode. Resp. Care, v. 29, p. 103-7, 1984

David CM. Medicina Intensiva. Editora Revinter. Rio de Janeiro, 2004. Págs: 1159.

de Fraga Gomes Martins L, da Silva Naue W, Skueresky AS, Bianchi T, Dias AS, Forgiarini LA. Effects of Combined Tracheal Suctioning and Expiratory Pause: A Crossover Randomized Clinical Trial. Indian J Crit Care Med. 2019 Oct;23(10):454-457. doi: 10.5005/jp-journals-10071-23263. — View Citation

Deppe SA, Kelly JW, Thoi LL, Chudy JH, Longfield RN, Ducey JP, Truwit CL, Antopol MR. Incidence of colonization, nosocomial pneumonia, and mortality in critically ill patients using a Trach Care closed-suction system versus an open-suction system: prospective, randomized study. Crit Care Med. 1990 Dec;18(12):1389-93. — View Citation

Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schönhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19. Review. — View Citation

Lemes DA, Zin WA, Guimaraes FS. Hyperinflation using pressure support ventilation improves secretion clearance and respiratory mechanics in ventilated patients with pulmonary infection: a randomised crossover trial. Aust J Physiother. 2009;55(4):249-54. — View Citation

Mattar JA, Sproesser AM, Gomes MA. A comparative study of oxygen transport between open and closed methods of tracheal suctioning. Intensive and Critical Care Digest, 1992.

McCarren B, Alison JA, Herbert RD. Manual vibration increases expiratory flow rate via increased intrapleural pressure in healthy adults: an experimental study. Aust J Physiother. 2006;52(4):267-71. — View Citation

Naue Wda S, da Silva AC, Güntzel AM, Condessa RL, de Oliveira RP, Rios Vieira SR. Increasing pressure support does not enhance secretion clearance if applied during manual chest wall vibration in intubated patients: a randomised trial. J Physiother. 2011;57(1):21-6. doi: 10.1016/S1836-9553(11)70003-0. — View Citation

Ntoumenopoulos G, Presneill JJ, McElholum M, Cade JF. Chest physiotherapy for the prevention of ventilator-associated pneumonia. Intensive Care Med. 2002 Jul;28(7):850-6. Epub 2002 May 24. — View Citation

Pepe PE, Marini JJ. Occult positive end-expiratory pressure in mechanically ventilated patients with airflow obstruction: the auto-PEEP effect. Am Rev Respir Dis. 1982 Jul;126(1):166-70. — View Citation

Ritz R, Scott LR, Coyle MB, Pierson DJ. Contamination of a multiple-use suction catheter in a closed-circuit system compared to contamination of a disposable, single-use suction catheter. Respir Care. 1986 Nov;31(11):1086-91. — View Citation

Sarmento GJV, et al. Fisioterapia Respiratória no Paciente Crítico: Rotinas Clínicas. 3° ed. rev e ampl- Barueri /SP. Editora: Manole, 2010.

Sarmento, GJ et al. Fisioterapia em UTI: Avaliação e Procedimentos. Editora Atheneu.Vol 1. São Paulo, 2006. Págs: 353.

Savian C, Paratz J, Davies A. Comparison of the effectiveness of manual and ventilator hyperinflation at different levels of positive end-expiratory pressure in artificially ventilated and intubated intensive care patients. Heart Lung. 2006 Sep-Oct;35(5):334-41. — View Citation

Taggart JA, Dorinsky NL, Sheahan JS. Airway pressures during closed system suctioning. Heart Lung. 1988 Sep;17(5):536-42. — View Citation

Van der Schans CP. Bronchial mucus transport. Respir Care. 2007 Sep;52(9):1150-6; discussion 1156-8. Review. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight of secretion aspirated (grams)	The secretion aspirated into the collection flask will be weighed on a precision laboratory scale.	Immediately after the application of one of the closed system aspiration techniques.
Secondary	Peripheral arterial oxygen saturation (SpO2) (%)	After the 3-second expiratory pause on the mechanical ventilator, the SpO2 will be visualized on the monitor of the patient, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Peak inspiratory pressure (PIP) (cm H2O)	The PIP will be visualized directly at mechanical ventilation monitor, and the value will be noted.	One minute after the application of the studied technique.
Secondary	End expiratory pressure (PEEP) (cmH2O)	The PEEP will be visualized directly at mechanical ventilation monitor, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Air trapping (AUTO-PEEP) (cmH2O)	The AUTO-PEEP will be visualized directly at mechanical ventilation monitor, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Mechanical ventilation circuit pressure (cmH2O)	The mechanical ventilation circuit pressure will be visualized directly at mechanical ventilation monitor, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Tidal volume (TV) (ml)	The TV will be visualized directly at mechanical ventilation monitor, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Endotracheal tube diameter (ETT) (mm)	The endotracheal tube diameter is directly written in the product package.	One minute after the application of the studied technique.
Secondary	Dynamic compliance (Cd) (ml/cmH2O)	The Cd will be visualized directly at mechanical ventilation monitor, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Resistance (R) (L/s)	The R will be visualized directly at mechanical ventilation monitor, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Drive pressure (cmH2O)	The drive pressure will be calculated by the difference between plateau pressure and positive end-expiratory pressure in the mechanical ventilation, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Heart rate (HR) (beats per minute)	After the 3-second expiratory pause on the mechanical ventilator, the HR will be visualized on the monitor of the patient, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Respiratory rate (RR) (breaths per minute).	After the 3-second expiratory pause on the mechanical ventilator, the RR will be visualized on the monitor of the patient, and the value will be noted.	One minute after the application of the studied technique.
Secondary	Mean arterial pressure (MAP) (mmHg)	After the 3-second expiratory pause on the mechanical ventilator, the MAP will be calculated using the systolic and diastolic blood pressure, and the value will be noted.	One minute after the application of the studied technique.