- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05537974
Open Suction vs. Closed Suction in ARDS
January 16, 2023 updated by: Cenk Kirakli, M.D., Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İzmir, Turkey, 35110
- University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Mechanically ventilated due to ARDS
Exclusion Criteria:
Hemodynamically unstable Air leaks syndrome (pneumothorax) Higher level of FiO2 (>60%) Chronic obstructive pulmonary disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Open Suction
Endotracheal aspiration will perform after the patient disconnect from mechanical ventilation
|
Clearance of endotracheal secretions via a catheter.
|
Other: Closed Suction
Endotracheal aspiration will perform without disconnection from mechanical ventilation
|
Clearance of endotracheal secretions via a catheter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One minute before suctioning, 1, 10, 20, 30 minutes after suctioning
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2022
Primary Completion (Actual)
October 31, 2022
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
September 8, 2022
First Submitted That Met QC Criteria
September 8, 2022
First Posted (Actual)
September 13, 2022
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 16, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGHCEAH-ICU-7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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