Mechanical VentilationNCT05579145
Tracheal Suctioning and Expiratory Pause in Bronchial Hygiene
A study testing 5-Second Expiratory Pause and 10-Second Expiratory Pause in people with Mechanical Ventilation, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- 5-Second Expiratory Pause and 10-Second Expiratory Pause
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Oct 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Undrained pneumothorax and hemothorax.
- Subcutaneous emphysema.
- Patients who refuse to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Luciane FG Martins, Master
- Recruiting
Luciane FG Martins
Porto Alegre, Rio Grande do Sul, 90035-003
Luciane FG Martins, Master, +555181598395, lfgmartins@hcpa.edu.br
Silvia Vieira, PhD, +555199686170, svieira@hcpa.edu.br
About this study
Official title: 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).
Read the 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.
- Conditions
- Mechanical Ventilation
- Being tested
- 5-Second Expiratory Pause, 10-Second Expiratory Pause
- Keywords
- Bronchial hygiene, Tracheal suctioning, Respiratory therapy, Intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 5-Second Expiratory Pause | Experimental | Closed system aspiration following by expiratory pause with mechanical ventilator for 5 seconds. Receives: Other: 5-Second Expiratory Pause |
| 10-Second Expiratory Pause | Experimental | Closed system aspiration following by expiratory pause with mechanical ventilator for 10 seconds. Receives: Other: 10-Second Expiratory Pause |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight of secretion aspirated (grams)
The secretion aspirated into the collection flask will be weighed on a precision laboratory scale.
Measured: Immediately after the application of one of the closed system aspiration techniques.
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One minute after the application of the studied technique.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Oct 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciane FG Martins, Master, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579145
- Sponsor's protocol ID
- 51995621.7.0000.5327
- Status last verified
- Nov 2022
- First submitted
- 21 Sep 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 18283429McCarren 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.
PubMed 17132121Amato 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.
PubMed 18026670Bhowmik 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.
PubMed 19091536Ntoumenopoulos 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.
PubMed 12122521Van der Schans CP. Bronchial mucus transport. Respir Care. 2007 Sep;52(9):1150-6; discussion 1156-8.
PubMed 17716383Sarmento, GJ et al. Fisioterapia em UTI: Avaliação e Procedimentos. Editora Atheneu.Vol 1. São Paulo, 2006. Págs: 353.
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.
PubMed 8650276Savian 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.
PubMed 16963365Carlon 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.
PubMed 3552445Mattar 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.
PubMed 2245613Ritz 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.
PubMed 10315714Taggart JA, Dorinsky NL, Sheahan JS. Airway pressures during closed system suctioning. Heart Lung. 1988 Sep;17(5):536-42.
PubMed 3417464
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Tracheal Suctioning and Expiratory Pause 5 or 10 Seconds: a Crossover Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05579145
- Acronym / sponsor ID
- 51995621.7.0000.5327
- Conditions
- Mechanical Ventilation
- Keywords
- Bronchial hygiene, Tracheal suctioning, Respiratory therapy, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-Second Expiratory Pause | Experimental | Other: 5-Second Expiratory PauseClosed system aspiration following by expiratory pause with mechanical ventilator for 5 seconds. |
| 10-Second Expiratory Pause | Experimental | Other: 10-Second Expiratory PauseClosed system aspiration following by expiratory pause with mechanical ventilator for 10 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- Undrained pneumothorax and hemothorax.
- Subcutaneous emphysema.
- Patients who refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Second Expiratory PausePatients 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. | Other | 5-Second Expiratory Pause |
| 10-Second Expiratory PausePatients 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. | Other | 10-Second Expiratory Pause |
Primary outcome
Weight of secretion aspirated (grams)
Time frame: Immediately after the application of one of the closed system aspiration techniques.
The secretion aspirated into the collection flask will be weighed on a precision laboratory scale.
13 secondary outcomes
Peripheral arterial oxygen saturation (SpO2) (%)
Time frame: One minute after the application of the studied technique.
Peak inspiratory pressure (PIP) (cm H2O)
Time frame: One minute after the application of the studied technique.
End expiratory pressure (PEEP) (cmH2O)
Time frame: One minute after the application of the studied technique.
Air trapping (AUTO-PEEP) (cmH2O)
Time frame: One minute after the application of the studied technique.
Mechanical ventilation circuit pressure (cmH2O)
Time frame: One minute after the application of the studied technique.
Tidal volume (TV) (ml)
Time frame: One minute after the application of the studied technique.
Endotracheal tube diameter (ETT) (mm)
Time frame: One minute after the application of the studied technique.
Dynamic compliance (Cd) (ml/cmH2O)
Time frame: One minute after the application of the studied technique.
Resistance (R) (L/s)
Time frame: One minute after the application of the studied technique.
Drive pressure (cmH2O)
Time frame: One minute after the application of the studied technique.
Heart rate (HR) (beats per minute)
Time frame: One minute after the application of the studied technique.
Respiratory rate (RR) (breaths per minute).
Time frame: One minute after the application of the studied technique.
Mean arterial pressure (MAP) (mmHg)
Time frame: One minute after the application of the studied technique.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 18283429Gosselink 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.
- Background: PubMed 17132121McCarren 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.
- Background: PubMed 18026670Amato 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.
- Background: PubMed 19091536Bhowmik 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.
- Background: PubMed 12122521Ntoumenopoulos 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.
- Background: PubMed 17716383Van der Schans CP. Bronchial mucus transport. Respir Care. 2007 Sep;52(9):1150-6; discussion 1156-8.
- BackgroundSarmento, GJ et al. Fisioterapia em UTI: Avaliação e Procedimentos. Editora Atheneu.Vol 1. São Paulo, 2006. Págs: 353.
- Background: PubMed 8650276Ciesla 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.
- Background: PubMed 16963365Savian 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.
- Background: PubMed 3552445Carlon 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.
- BackgroundMattar 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.
- BackgroundCraig 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciane FG Martins, Master principal investigator
Hospital de Clinicas de Porto Alegre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-Second Expiratory Pause and 10-Second Expiratory Pause in people with Mechanical Ventilation, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luciane FG Martins, Master (55 51 81598395, lfgmartins@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight of secretion aspirated (grams) (time frame: Immediately after the application of one of the closed system aspiration techniques.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05579145, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.