Mechanical VentilationNCT03256214
Acute Effects of Open and Closed Suction Systems in Mechanically Ventilated Patients
A study testing Closed suction system and Open suction system in people with Mechanical Ventilation, run by University of Sao Paulo.
Trial summary
Seventy-one patients in intensive care were randomized for initial treatment with open suction systems or closed suction systems in a cross-over design. Pulmonary and cardiovascular physiology was assessed immediately before and after three 10-second aspirations per suction. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Closed suction system and Open suction system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2015to 17 Apr 2017
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years old;
- intubated with a 7.5mm endotracheal tube;
- mechanically ventilated.
Who cannot join
- upper gastrointestinal bleeding;
- hemodynamic instability;
- airway bleeding;
- previous lung diseases.
About this study
Official title: Acute Effects of Open and Closed Suction Systems on Pulmonary Mechanics and Cardiovascular Function in Mechanically Ventilated Patients
Seventy-one patients in intensive care were randomized for initial treatment with open suction systems or closed suction systems in a cross-over design. Pulmonary and cardiovascular physiology was assessed immediately before and after three 10-second aspirations per suction. Were analyzed the effect of each suction system on physiologic parameters while adjusting for their respective values prior to suction.
Read the detailed description
Study Participants. The sample consisted of 71 subjects, both genders, hospitalized in intensive care units. This study protocol was approved by the Research Ethics Committee of Heliopolis Hospital - Sao Paulo - Brazil.
Patients were randomized in the following way: patients hospitalized in the odd beds of ICU were aspirated initially by open suction system (OSS) and later by the closed suction system (CSS); patients hospitalized in the even beds were aspirated by CSS, initially, and subsequently by the OSS.
Cardiopulmonary measures: Eligible patients were evaluated for the presence or absence of neural stimulation to spontaneous ventilation (drive breathing). If the patients showed spontaneous respiratory movements, they were sedated to the level four of Ramsay scale. After this initial evaluation, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), respiratory rate (RR), oxygen saturation (SAT), tidal volume (Vt), peak pressure (Ppeak), plateau pressure (Pplat), positive end expiratory pressure (PEEP), and inspiratory flow (V) were measured. The HR and SAT data were collected by visualization of DX 2010 multiparameter monitor from Dixtal. SBP, DBP and MBP were obtained by a single measurement provided by the same monitor. Data of peak pressure, plateau pressure, positive end expiratory pressure, inspiratory flow and tidal volume were used to calculate compliance (C) and airway resistance (R). Data were collected before and after tracheal aspiration.
Pulmonary Suction: After the initial data were obtained, patients who were under volume-controlled ventilation mode (VCV) were submitted to the first aspiration procedure according to randomization described above. Patients who were under pressure-controlled ventilation mode (PCV) were changed to VCV mode, respecting the individual mean tidal volume, which means that the tidal volume of the patient under PCV would be used to ventilate in VCV. All patients were ventilated with a Savina (Drager) mechanical ventilator. Aspiration procedures and data collection were done by a health care professional unaware of the study regimes or objectives. After the measurement of the initial parameters, patients underwent the procedure of aspiration in an open or closed system according to the randomization described above. All patients were aspirated by a system that had not been used previously. The procedure was timed and required 10 seconds to insert and remove the aspiration catheter, with each aspiration performed three times. The outside diameter of the aspiration catheter had half the inner diameter of the endotracheal tube, and the negative pressure was adjusted between 70 and 100 mmHg. At the end of the aspiration procedure, physiological assessments were repeated. Patients were returned to nursing care and underwent the second procedure after six hours from initial aspiration.
- Conditions
- Mechanical Ventilation
- Being tested
- Closed suction system, Open suction system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed suction systemProcedure or surgery
In mechanically ventilated patients, intratracheal secretions were aspirated with closed suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with open suction system.
Open suction systemProcedure or surgery
In mechanically ventilated patients, intratracheal secretions were aspirated with open suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with closed suction system.
| Study group | Role | What they receive |
|---|---|---|
| Closed suction system | Experimental | Patients in mechanical ventilation were aspirated with closed suction system. Receives: Procedure: Closed suction system |
| Open suction system | Active comparator | Patients in mechanical ventilation were aspirated with open suction system. Receives: Procedure: Open suction system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in Pulmonary parameters when comparing closed and open suction systems.
Assessment of Peak Pressure (cmH20) in both closed and open suction systems.
Measured: 1 day
Improvements in Cardiovascular parameters when comparing Closed and open suction systems.
Assessment of Blood Pressure (mmHg) in both closed and open suction systems.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start2 Feb 2015
- Primary completion15 Jul 2016
- Study completion17 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of Sao PauloThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talita Dias da Silva, University of Sao Paulo
- Investigators
- Rodrigo D Raimundo, Ph.D., Principal investigator, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256214
- Sponsor's protocol ID
- 467
- Status last verified
- Aug 2017
- First submitted
- 18 Jul 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raimundo RD, Sato MA, da Silva TD, de Abreu LC, Valenti VE, Riggs DW, Perrow Carll A. Open and Closed Endotracheal Suction Systems Divergently Affect Pulmonary Function in Mechanically Ventilated Subjects. Respir Care. 2021 May;66(5):785-792. doi: 10.4187/respcare.08511. Epub 2021 Mar 9.
PubMed 33688090
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Open and Closed Suction Systems on Pulmonary Mechanics and Cardiovascular Function in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT03256214
- Acronym / sponsor ID
- 467
- Conditions
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 17 Apr 2017 (actual)
- First posted
- 21 Aug 2017 (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.
Seventy-one patients in intensive care were randomized for initial treatment with open suction systems or closed suction systems in a cross-over design. Pulmonary and cardiovascular physiology was assessed immediately before and after three 10-second aspirations per suction. Were analyzed the effect of each suction system on physiologic parameters while adjusting for their respective values prior to suction.
Detailed description
Study Participants. The sample consisted of 71 subjects, both genders, hospitalized in intensive care units. This study protocol was approved by the Research Ethics Committee of Heliopolis Hospital - Sao Paulo - Brazil.
Patients were randomized in the following way: patients hospitalized in the odd beds of ICU were aspirated initially by open suction system (OSS) and later by the closed suction system (CSS); patients hospitalized in the even beds were aspirated by CSS, initially, and subsequently by the OSS.
Cardiopulmonary measures: Eligible patients were evaluated for the presence or absence of neural stimulation to spontaneous ventilation (drive breathing). If the patients showed spontaneous respiratory movements, they were sedated to the level four of Ramsay scale. After this initial evaluation, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), respiratory rate (RR), oxygen saturation (SAT), tidal volume (Vt), peak pressure (Ppeak), plateau pressure (Pplat), positive end expiratory pressure (PEEP), and inspiratory flow (V) were measured. The HR and SAT data were collected by visualization of DX 2010 multiparameter monitor from Dixtal. SBP, DBP and MBP were obtained by a single measurement provided by the same monitor. Data of peak pressure, plateau pressure, positive end expiratory pressure, inspiratory flow and tidal volume were used to calculate compliance (C) and airway resistance (R). Data were collected before and after tracheal aspiration.
Pulmonary Suction: After the initial data were obtained, patients who were under volume-controlled ventilation mode (VCV) were submitted to the first aspiration procedure according to randomization described above. Patients who were under pressure-controlled ventilation mode (PCV) were changed to VCV mode, respecting the individual mean tidal volume, which means that the tidal volume of the patient under PCV would be used to ventilate in VCV. All patients were ventilated with a Savina (Drager) mechanical ventilator. Aspiration procedures and data collection were done by a health care professional unaware of the study regimes or objectives. After the measurement of the initial parameters, patients underwent the procedure of aspiration in an open or closed system according to the randomization described above. All patients were aspirated by a system that had not been used previously. The procedure was timed and required 10 seconds to insert and remove the aspiration catheter, with each aspiration performed three times. The outside diameter of the aspiration catheter had half the inner diameter of the endotracheal tube, and the negative pressure was adjusted between 70 and 100 mmHg. At the end of the aspiration procedure, physiological assessments were repeated. Patients were returned to nursing care and underwent the second procedure after six hours from initial aspiration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed suction system | Experimental | Procedure: Closed suction systemPatients in mechanical ventilation were aspirated with closed suction system. |
| Open suction system | Active comparator | Procedure: Open suction systemPatients in mechanical ventilation were aspirated with open suction system. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 years old;
- intubated with a 7.5mm endotracheal tube;
- mechanically ventilated.
Key exclusion criteria (4 listed)
- upper gastrointestinal bleeding;
- hemodynamic instability;
- airway bleeding;
- previous lung diseases.
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 |
|---|---|---|
| Closed suction systemIn mechanically ventilated patients, intratracheal secretions were aspirated with closed suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with open suction system. | Procedure or surgery | Closed suction system |
| Open suction systemIn mechanically ventilated patients, intratracheal secretions were aspirated with open suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with closed suction system. | Procedure or surgery | Open suction system |
Primary outcome
Improvements in Pulmonary parameters when comparing closed and open suction systems.
Time frame: 1 day
Assessment of Peak Pressure (cmH20) in both closed and open suction systems.
Improvements in Cardiovascular parameters when comparing Closed and open suction systems.
Time frame: 1 day
Assessment of Blood Pressure (mmHg) in both closed and open suction systems.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Derived from this study: PubMed 33688090Raimundo RD, Sato MA, da Silva TD, de Abreu LC, Valenti VE, Riggs DW, Perrow Carll A. Open and Closed Endotracheal Suction Systems Divergently Affect Pulmonary Function in Mechanically Ventilated Subjects. Respir Care. 2021 May;66(5):785-792. doi: 10.4187/respcare.08511. Epub 2021 Mar 9.
- Individual participant dataSharing planned: Undecided
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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.
Rodrigo D Raimundo, Ph.D. principal investigator
Faculdade de Medicina do ABC
Questions about this trial
What is this clinical trial studying?
A study testing Closed suction system and Open suction system in people with Mechanical Ventilation, run by University of Sao Paulo.
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 4 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: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvements in Pulmonary parameters when comparing closed and open suction systems. (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT03256214, which also lists 1 linked publication.
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 21 Aug 2017.