NCT05537974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

September 8, 2022

Last Update Submit

January 16, 2023

Conditions

Keywords

Endotracheal aspiration, Electric impedance tomography

Outcome Measures

Primary Outcomes (1)

  • 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.

    One minute before suctioning, 1, 10, 20, 30 minutes after suctioning

Study Arms (2)

Open Suction

OTHER

Endotracheal aspiration will perform after the patient disconnect from mechanical ventilation

Procedure: Endotracheal aspiration

Closed Suction

OTHER

Endotracheal aspiration will perform without disconnection from mechanical ventilation

Procedure: Endotracheal aspiration

Interventions

Clearance of endotracheal secretions via a catheter.

Closed SuctionOpen Suction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanically ventilated due to ARDS

You may not qualify if:

  • Hemodynamically unstable Air leaks syndrome (pneumothorax) Higher level of FiO2 (\>60%) Chronic obstructive pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit

Izmir, 35110, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 13, 2022

Study Start

September 15, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations