Secretion; Excess, SalivationNCT04053751
Effects of Open and Closed System Suctioning on Suctioning Frequency and Amount of Secretion
A study testing closed suctioning system in people with Secretion; Excess, Salivation, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Tracheal suctioning is a process which is often applied to patients' care who have an artificial airway and whose respiration is achieved via mechanical ventilation. When secretions are not cleaned enough, it causes a variety of complications in the patient from hypoxemia to infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secretion; Excess, Salivation
- What is being tested?
- closed suctioning system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 20 Dec 2019
- 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
- orally intubated in first 96 hours
- stabilized patients in conditionally
- platelets > 50.000
- not have hemorrhagic secretions
Who cannot join
- hemodynamically unstabilized patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Open and Closed System Endotracheal Suctioning Methods on Suctioning Frequency and Amount of Secretion
Tracheal suctioning is a process which is often applied to patients' care who have an artificial airway and whose respiration is achieved via mechanical ventilation. When secretions are not cleaned enough, it causes a variety of complications in the patient from hypoxemia to infection.
It is reported that the studies with nurses in clinical practice have shown that they have opinions such as the closed system does not suction the patients effectively as the open system does; it remains incapable in removing secretions, thus the suctioning process is being applied more frequently.
Therefore this study is designed to examine the amount of secretions and frequency of suctioning as a result of open and closed suctioning systems.
Read the detailed description
Patients will be monitored for two days. On the first day, the patient will be followed up with an open system and the second day closed suctioning system will be used, or the patient will be followed up with a closed system on the first day and followed with an open system on the second day. The patients are randomly allocated on the first follow up days. The follow-up period has two consecutive days. suctioning will be performed for 12 hours in one day. The number of suctions will be recorded. The amount of secretion will be accumulated in the mucus collection vessel. At the end of the day, the secretion will be weighed with precision weighing.
- Conditions
- Secretion; Excess, Salivation
- Being tested
- closed suctioning system
- Keywords
- intensive care unit, endotracheal suctioning, open suctioning system, closed suctioning system, nursing
- Medical subject headings
- Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed suctioning systemProcedure or surgery
a randomized allocated patient will be monitored for two days. Closed suctioning system will evaluate as experimental group. open suctioning system will evaluate as control group.
| Study group | Role | What they receive |
|---|---|---|
| closed suctioning system | Experimental | Closed suctioning system will be compared with open suctioning system Receives: Procedure: closed suctioning system |
| open suctioning system | No intervention | The patient will be monitored with closed system for one day and open aspiration system on the other day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of suctioning
frequency of suctioning in a half of a day
Measured: 12 hours of a day
amount of secretion
amount of secretion in a half of a day
Measured: 12 hours of a day
Secondary outcomes (2)
spo2
differences in spo2 between open and closed suctioning systems
Measured: 12 hours of a day
tidal volume
differences in tidal volume between open and closed suctioning systems
Measured: 12 hours of a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Aug 2019
- Primary completion15 Dec 2019
- Study completion20 Dec 2019
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 Secretion; Excess, SalivationStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled crossover trial. There are two arms. open and closed suctioning systems (OSS vs CSS). the patients are randomized. They are monitorized for two days. If a patient is suctioned via OSS in the first enrolled day, the same patient is suctioned via CSS in the second enrolled day. For CSS, vice versa.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilkin Yilmaz, Dokuz Eylul University
- Investigators
- Dilek Ozden, PhD, Study director, Dokuz Eylul University Faculty of NursingIlkin Yilmaz, PhD, Principal investigator, Dokuz Eylul University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053751
- Sponsor's protocol ID
- 2018.KB.SAG.025
- Status last verified
- May 2022
- First submitted
- 9 Aug 2019
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the patients data with other researchers.
Publications
Yilmaz I, Ozden D. The effects of open and closed system endotracheal suctioning methods on suctioning frequency, amount of secretion, and haemodynamics: A single-blind, randomised, 2 x 2 crossover trial. Aust Crit Care. 2024 Jan;37(1):25-33. doi: 10.1016/j.aucc.2023.09.002. Epub 2023 Oct 11.
PubMed 37833132
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Open and Closed System Endotracheal Suctioning Methods on Suctioning Frequency and Amount of Secretion
- ClinicalTrials.gov ID
- NCT04053751
- Acronym / sponsor ID
- 2018.KB.SAG.025
- Conditions
- Secretion; Excess, Salivation
- Keywords
- intensive care unit, endotracheal suctioning, open suctioning system, closed suctioning system, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 12 Aug 2019 (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.
Tracheal suctioning is a process which is often applied to patients' care who have an artificial airway and whose respiration is achieved via mechanical ventilation. When secretions are not cleaned enough, it causes a variety of complications in the patient from hypoxemia to infection.
It is reported that the studies with nurses in clinical practice have shown that they have opinions such as the closed system does not suction the patients effectively as the open system does; it remains incapable in removing secretions, thus the suctioning process is being applied more frequently.
Therefore this study is designed to examine the amount of secretions and frequency of suctioning as a result of open and closed suctioning systems.
Detailed description
Patients will be monitored for two days. On the first day, the patient will be followed up with an open system and the second day closed suctioning system will be used, or the patient will be followed up with a closed system on the first day and followed with an open system on the second day. The patients are randomly allocated on the first follow up days. The follow-up period has two consecutive days. suctioning will be performed for 12 hours in one day. The number of suctions will be recorded. The amount of secretion will be accumulated in the mucus collection vessel. At the end of the day, the secretion will be weighed with precision weighing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled crossover trial. There are two arms. open and closed suctioning systems (OSS vs CSS). the patients are randomized. They are monitorized for two days. If a patient is suctioned via OSS in the first enrolled day, the same patient is suctioned via CSS in the second enrolled day. For CSS, vice versa.
| Arm | Type | Receives |
|---|---|---|
| closed suctioning system | Experimental | Procedure: closed suctioning systemClosed suctioning system will be compared with open suctioning system |
| open suctioning system | No intervention | –The patient will be monitored with closed system for one day and open aspiration system on the other day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- orally intubated in first 96 hours
- stabilized patients in conditionally
- platelets > 50.000
- not have hemorrhagic secretions
Key exclusion criteria (1 listed)
- hemodynamically unstabilized patients
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 suctioning systema randomized allocated patient will be monitored for two days. Closed suctioning system will evaluate as experimental group. open suctioning system will evaluate as control group. | Procedure or surgery | closed suctioning system |
Primary outcome
frequency of suctioning
Time frame: 12 hours of a day
frequency of suctioning in a half of a day
amount of secretion
Time frame: 12 hours of a day
amount of secretion in a half of a day
2 secondary outcomes
spo2
Time frame: 12 hours of a day
tidal volume
Time frame: 12 hours of a day
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 27 May 2022.
- Derived from this study: PubMed 37833132Yilmaz I, Ozden D. The effects of open and closed system endotracheal suctioning methods on suctioning frequency, amount of secretion, and haemodynamics: A single-blind, randomised, 2 x 2 crossover trial. Aust Crit Care. 2024 Jan;37(1):25-33. doi: 10.1016/j.aucc.2023.09.002. Epub 2023 Oct 11.
- Individual participant dataSharing planned: No. There is no plan to share the patients data with other researchers.
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.
Dilek Ozden, PhD study director
Dokuz Eylul University Faculty of Nursing
Ilkin Yilmaz, PhD principal investigator
Dokuz Eylul University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed suctioning system in people with Secretion; Excess, Salivation, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
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?
frequency of suctioning (time frame: 12 hours of a 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 NCT04053751, 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 27 May 2022.