NCT05579145

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

September 21, 2022

Last Update Submit

November 1, 2022

Conditions

Mechanical Ventilation

Keywords

Bronchial hygieneTracheal suctioningRespiratory therapyIntensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Peripheral arterial oxygen saturation (SpO2) (%)

    One minute after the application of the studied technique.

  • Peak inspiratory pressure (PIP) (cm H2O)

    One minute after the application of the studied technique.

  • End expiratory pressure (PEEP) (cmH2O)

    One minute after the application of the studied technique.

  • Air trapping (AUTO-PEEP) (cmH2O)

    One minute after the application of the studied technique.

  • Mechanical ventilation circuit pressure (cmH2O)

    One minute after the application of the studied technique.

  • +8 more secondary outcomes

Study Arms (2)

5-Second Expiratory Pause

EXPERIMENTAL

Closed system aspiration following by expiratory pause with mechanical ventilator for 5 seconds.

Other: 5-Second Expiratory Pause

10-Second Expiratory Pause

EXPERIMENTAL

Closed system aspiration following by expiratory pause with mechanical ventilator for 10 seconds.

Other: 10-Second Expiratory Pause

Interventions

5-Second Expiratory PauseOTHER

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.

5-Second Expiratory Pause
10-Second Expiratory PauseOTHER

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.

10-Second Expiratory Pause

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

Luciane FG Martins

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

Related Publications (22)

  • 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.

    PMID: 18283429BACKGROUND

  • 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.

    PMID: 17132121BACKGROUND

  • 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.

    PMID: 18026670BACKGROUND

  • 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.

    PMID: 19091536BACKGROUND

  • 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.

    PMID: 12122521BACKGROUND

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

    PMID: 17716383BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 8650276BACKGROUND

  • 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.

    PMID: 16963365BACKGROUND

  • 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.

    PMID: 3552445BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 2245613BACKGROUND

  • 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.

    PMID: 10315714BACKGROUND

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

    PMID: 3417464BACKGROUND

  • 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.

    PMID: 7046541BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 19929767BACKGROUND

  • 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.

    PMID: 21402326BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 31749553BACKGROUND

Study Officials

  • Luciane FG Martins, Master

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciane FG Martins, Master

CONTACT

55 51 81598395lfgmartins@hcpa.edu.br

Silvia Vieira, PhD

CONTACT

55 51 99686170svieira@hcpa.edu.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

October 13, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)