Acute Respiratory Distress SyndromeNCT05537974
Open Suction vs. Closed Suction in ARDS
A study testing Endotracheal aspiration in people with Acute Respiratory Distress Syndrome, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The alveoli tend to collapse in patients with ARDS. Endotracheal aspiration may increase alveolar collapse by decreasing the end-expiratory lung volume. The hypothesis is that closed endotracheal aspiration led to less end-expiratory volume loss when compared to open endotracheal aspiration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Endotracheal aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 31 Oct 2022
- 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
- Mechanically ventilated due to ARDS
Who cannot join
- Hemodynamically unstable Air leaks syndrome (pneumothorax) Higher level of FiO2 (>60%) Chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
Izmir, 35110
About this study
Official title: Effect of Endotracheal Aspiration on End-expiratory Lung Volume in Patients With ARDS, Comparison of Open vs. Closed Suction, A Randomize Cross-over Study
The alveoli tend to collapse in patients with ARDS. Endotracheal aspiration may increase alveolar collapse by decreasing the end-expiratory lung volume. The hypothesis is that closed endotracheal aspiration led to less end-expiratory volume loss when compared to open endotracheal aspiration.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Endotracheal aspiration
- Keywords
- Endotracheal aspiration, Electric impedance tomography
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal aspirationProcedure or surgery
Clearance of endotracheal secretions via a catheter.
| Study group | Role | What they receive |
|---|---|---|
| Open Suction | Other | Endotracheal aspiration will perform after the patient disconnect from mechanical ventilation Receives: Procedure: Endotracheal aspiration |
| Closed Suction | Other | Endotracheal aspiration will perform without disconnection from mechanical ventilation Receives: Procedure: Endotracheal aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
End expiratory lung volume (EELV)
End expiratory lung impedance (EELI) will be measured wit electric impedance tomography. Change in EELI representative of change in EELV.
Measured: One minute before suctioning, 1, 10, 20, 30 minutes after suctioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start15 Sep 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 Acute Respiratory Distress SyndromeStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a crossover study and suction procedure was made in a random order with 60 minutes wash out period between two suction maneuvers. Patients were randomized after intubation; randomization was made with sealed envelopes. All patients mechanically ventilated with lung protective ventilation strategy. Before the suctioning the patients ventilated with 100% of oxygen for 60 seconds. In open suction, the patient was disconnected from mechanical ventilator, the aspiration catheter advanced until resistance met after that the catheter withdraw 1 cm before aspiration. During endotracheal suctioning a negative pressure applied two times for 5 seconds. The negative pressure was set 150 mmHg. All suctioning maneuvers performed by intensivists.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Kirakli, M.D., Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537974
- Sponsor's protocol ID
- IGHCEAH-ICU-7
- Status last verified
- Jan 2023
- First submitted
- 8 Sep 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildirim S, Saygili SM, Sunecli O, Kirakli C. Comparison of the effects of open and closed aspiration on end-expiratory lung volume in acute respiratory distress syndrome. Korean J Anesthesiol. 2024 Feb;77(1):115-121. doi: 10.4097/kja.23194. Epub 2023 May 22.
PubMed 37211764
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endotracheal Aspiration on End-expiratory Lung Volume in Patients With ARDS, Comparison of Open vs. Closed Suction, A Randomize Cross-over Study
- ClinicalTrials.gov ID
- NCT05537974
- Acronym / sponsor ID
- IGHCEAH-ICU-7
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Endotracheal aspiration, Electric impedance tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 13 Sep 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.
The alveoli tend to collapse in patients with ARDS. Endotracheal aspiration may increase alveolar collapse by decreasing the end-expiratory lung volume. The hypothesis is that closed endotracheal aspiration led to less end-expiratory volume loss when compared to open endotracheal aspiration.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a crossover study and suction procedure was made in a random order with 60 minutes wash out period between two suction maneuvers. Patients were randomized after intubation; randomization was made with sealed envelopes. All patients mechanically ventilated with lung protective ventilation strategy. Before the suctioning the patients ventilated with 100% of oxygen for 60 seconds. In open suction, the patient was disconnected from mechanical ventilator, the aspiration catheter advanced until resistance met after that the catheter withdraw 1 cm before aspiration. During endotracheal suctioning a negative pressure applied two times for 5 seconds. The negative pressure was set 150 mmHg. All suctioning maneuvers performed by intensivists.
| Arm | Type | Receives |
|---|---|---|
| Open Suction | Other | Procedure: Endotracheal aspirationEndotracheal aspiration will perform after the patient disconnect from mechanical ventilation |
| Closed Suction | Other | Procedure: Endotracheal aspirationEndotracheal aspiration will perform without disconnection from mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanically ventilated due to ARDS
Key exclusion criteria (1 listed)
- Hemodynamically unstable Air leaks syndrome (pneumothorax) Higher level of FiO2 (>60%) Chronic obstructive pulmonary disease
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 |
|---|---|---|
| Endotracheal aspirationClearance of endotracheal secretions via a catheter. | Procedure or surgery | Closed Suction, Open Suction |
Primary outcome
End expiratory lung volume (EELV)
Time frame: One minute before suctioning, 1, 10, 20, 30 minutes after suctioning
End expiratory lung impedance (EELI) will be measured wit electric impedance tomography. Change in EELI representative of change in EELV.
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 18 Jan 2023.
- Derived from this study: PubMed 37211764Yildirim S, Saygili SM, Sunecli O, Kirakli C. Comparison of the effects of open and closed aspiration on end-expiratory lung volume in acute respiratory distress syndrome. Korean J Anesthesiol. 2024 Feb;77(1):115-121. doi: 10.4097/kja.23194. Epub 2023 May 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal aspiration in people with Acute Respiratory Distress Syndrome, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital 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 1 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 18 Jan 2023. 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?
End expiratory lung volume (EELV) (time frame: One minute before suctioning, 1, 10, 20, 30 minutes after suctioning). 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 NCT05537974, 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 18 Jan 2023.