Tracheal Suctioning and Expiratory Pause in Bronchial Hygiene

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

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).

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Other: 5-Second Expiratory Pause; Other: 10-Second Expiratory Pause

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luciane FG Martins, Master; Phone Number: 55 51 81598395; Email: lfgmartins@hcpa.edu.br
• Study Contact Backup: Name: Silvia Vieira, PhD; Phone Number: 55 51 99686170; Email: svieira@hcpa.edu.br

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
      • Recruiting
      • Luciane FG Martins
      • Contact: Luciane FG Martins, Master; Phone Number: +555181598395; Email: lfgmartins@hcpa.edu.br
      • Contact: Silvia Vieira, PhD; Phone Number: +555199686170; Email: svieira@hcpa.edu.br
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
      • Recruiting
      • Hospital De Clinicas De Porto Alegre
      • Contact: Luciane FG Martins, Master

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5-Second Expiratory Pause; Closed system aspiration following by expiratory pause with mechanical ventilator for 5 seconds.	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.
Experimental: 10-Second Expiratory Pause; Closed system aspiration following by expiratory pause with mechanical ventilator for 10 seconds.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Luciane FG Martins, Master, Hospital De Clinicas De Porto Alegre

Publications and helpful links

General Publications

• Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer 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.
• 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. doi: 10.1016/s0004-9514(06)70006-x.
• Van der Schans CP. Bronchial mucus transport. Respir Care. 2007 Sep;52(9):1150-6; discussion 1156-8.
• Ciesla ND. Chest physical therapy for patients in the intensive care unit. Phys Ther. 1996 Jun;76(6):609-25. doi: 10.1093/ptj/76.6.609.
• 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.
• 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. doi: 10.1016/j.hrtlng.2006.02.003.
• Naue Wda S, da Silva AC, Guntzel 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.
• Taggart JA, Dorinsky NL, Sheahan JS. Airway pressures during closed system suctioning. Heart Lung. 1988 Sep;17(5):536-42.
• 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. doi: 10.1164/arrd.1982.126.1.166.
• Amato MB, Carvalho CR, Isola A, Vieira S, Rotman V, Moock M, Jose A, Franca S. [Mechanical ventilation in Acute Lung Injury (ALI)/Acute Respiratory Discomfort Syndrome (ARDS)]. J Bras Pneumol. 2007;33 Suppl 2S:S119-27. doi: 10.1590/s1806-37132007000800007. No abstract available. Portuguese.
• 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.
• 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. doi: 10.1007/s00134-002-1342-2. Epub 2002 May 24.
• Sarmento, GJ et al. Fisioterapia em UTI: Avaliação e Procedimentos. Editora Atheneu.Vol 1. São Paulo, 2006. Págs: 353.
• Carlon GC, Fox SJ, Ackerman NJ. Evaluation of a closed-tracheal suction system. Crit Care Med. 1987 May;15(5):522-5. doi: 10.1097/00003246-198705000-00015.
• 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.
• 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
• 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. doi: 10.1097/00003246-199012000-00016.
• 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.
• Sarmento GJV, et al. Fisioterapia Respiratória no Paciente Crítico: Rotinas Clínicas. 3° ed. rev e ampl- Barueri /SP. Editora: Manole, 2010.
• 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. doi: 10.1016/s0004-9514(09)70004-2.
• Azeredo CA, Bezerra RM. Manobras de Fisioterapia Respiratória na UTI.Editora SOS Pulmão/Cuca. Rio de Janeiro, 2004. Págs: 139.
• David CM. Medicina Intensiva. Editora Revinter. Rio de Janeiro, 2004. Págs: 1159.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Intensive care unit; Respiratory therapy; Bronchial hygiene; Tracheal suctioning
• Other Study ID Numbers: 51995621.7.0000.5327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No