Back to resultsOpen Suction vs. Closed Suction in ARDS
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Endotracheal aspiration
Sponsored by
About this trial
This is an interventional screening trial for Acute Respiratory Distress Syndrome focused on measuring Endotracheal aspiration, Electric impedance tomography
Eligibility Criteria
Inclusion Criteria:
Mechanically ventilated due to ARDS
Exclusion Criteria:
Hemodynamically unstable Air leaks syndrome (pneumothorax) Higher level of FiO2 (>60%) Chronic obstructive pulmonary disease
Sites / Locations
- University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Open Suction
Closed Suction
Arm Description
Endotracheal aspiration will perform after the patient disconnect from mechanical ventilation
Endotracheal aspiration will perform without disconnection from mechanical ventilation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05537974
First Posted
September 8, 2022
Last Updated
January 16, 2023
Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05537974
Brief Title
Open Suction vs. Closed Suction in ARDS
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Endotracheal aspiration, Electric impedance tomography
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Suction
Arm Type
Other
Arm Description
Endotracheal aspiration will perform after the patient disconnect from mechanical ventilation
Arm Title
Closed Suction
Arm Type
Other
Arm Description
Endotracheal aspiration will perform without disconnection from mechanical ventilation
Intervention Type
Procedure
Intervention Name(s)
Endotracheal aspiration
Intervention Description
Clearance of endotracheal secretions via a catheter.
Primary Outcome Measure Information:
Title
End expiratory lung volume (EELV)
Description
End expiratory lung impedance (EELI) will be measured wit electric impedance tomography. Change in EELI representative of change in EELV.
Time Frame
One minute before suctioning, 1, 10, 20, 30 minutes after suctioning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mechanically ventilated due to ARDS
Exclusion Criteria:
Hemodynamically unstable Air leaks syndrome (pneumothorax) Higher level of FiO2 (>60%) Chronic obstructive pulmonary disease
Facility Information:
Facility Name
University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
City
İzmir
ZIP/Postal Code
35110
Country
Turkey
12. IPD Sharing Statement
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Open Suction vs. Closed Suction in ARDS
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