NCT04053751

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

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

Study Start

First participant enrolled

August 1, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

August 9, 2019

Last Update Submit

May 26, 2022

Conditions

Keywords

intensive care unitendotracheal suctioningopen suctioning systemclosed suctioning systemnursing

Outcome Measures

Primary Outcomes (2)

  • frequency of suctioning

    frequency of suctioning in a half of a day

    12 hours of a day

  • amount of secretion

    amount of secretion in a half of a day

    12 hours of a day

Secondary Outcomes (2)

  • spo2

    12 hours of a day

  • tidal volume

    12 hours of a day

Study Arms (2)

closed suctioning system

EXPERIMENTAL

Closed suctioning system will be compared with open suctioning system

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.

Interventions

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.

closed suctioning system

Eligibility Criteria

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

You may qualify if:

  • orally intubated in first 96 hours
  • stabilized patients in conditionally
  • platelets \> 50.000
  • not have hemorrhagic secretions

You may not qualify if:

  • hemodynamically unstabilized patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sialorrhea

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Dilek Ozden, PhD

    Dokuz Eylul University Faculty of Nursing

    STUDY DIRECTOR
  • Ilkin Yilmaz, PhD

    Dokuz Eylul University Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 12, 2019

Study Start

August 1, 2019

Primary Completion

December 15, 2019

Study Completion

December 20, 2019

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share the patients data with other researchers.

Locations