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Effects of Open and Closed System Suctioning on Suctioning Frequency and Amount of Secretion

Primary Purpose

Secretion; Excess, Salivation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
closed suctioning system
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Secretion; Excess, Salivation focused on measuring intensive care unit, endotracheal suctioning, open suctioning system, closed suctioning system, nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • hemodynamically unstabilized patients

Sites / Locations

  • Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

closed suctioning system

open suctioning system

Arm Description

Closed suctioning system will be compared with open suctioning system

The patient will be monitored with closed system for one day and open aspiration system on the other day.

Outcomes

Primary Outcome Measures

frequency of suctioning
frequency of suctioning in a half of a day
amount of secretion
amount of secretion in a half of a day

Secondary Outcome Measures

spo2
differences in spo2 between open and closed suctioning systems
tidal volume
differences in tidal volume between open and closed suctioning systems

Full Information

First Posted
August 9, 2019
Last Updated
May 26, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04053751
Brief Title
Effects of Open and Closed System Suctioning on Suctioning Frequency and Amount of Secretion
Official Title
Effects of Open and Closed System Endotracheal Suctioning Methods on Suctioning Frequency and Amount of Secretion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

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
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.
Detailed Description
Patients will be monitored for two days. On the first day, the patient will be followed up with an open system and the second day closed suctioning system will be used, or the patient will be followed up with a closed system on the first day and followed with an open system on the second day. The patients are randomly allocated on the first follow up days. The follow-up period has two consecutive days. suctioning will be performed for 12 hours in one day. The number of suctions will be recorded. The amount of secretion will be accumulated in the mucus collection vessel. At the end of the day, the secretion will be weighed with precision weighing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secretion; Excess, Salivation
Keywords
intensive care unit, endotracheal suctioning, open suctioning system, closed suctioning system, nursing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
closed suctioning system
Arm Type
Experimental
Arm Description
Closed suctioning system will be compared with open suctioning system
Arm Title
open suctioning system
Arm Type
No Intervention
Arm Description
The patient will be monitored with closed system for one day and open aspiration system on the other day.
Intervention Type
Procedure
Intervention Name(s)
closed suctioning system
Intervention Description
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.
Primary Outcome Measure Information:
Title
frequency of suctioning
Description
frequency of suctioning in a half of a day
Time Frame
12 hours of a day
Title
amount of secretion
Description
amount of secretion in a half of a day
Time Frame
12 hours of a day
Secondary Outcome Measure Information:
Title
spo2
Description
differences in spo2 between open and closed suctioning systems
Time Frame
12 hours of a day
Title
tidal volume
Description
differences in tidal volume between open and closed suctioning systems
Time Frame
12 hours of a day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: orally intubated in first 96 hours stabilized patients in conditionally platelets > 50.000 not have hemorrhagic secretions Exclusion Criteria: hemodynamically unstabilized patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Ozden, PhD
Organizational Affiliation
Dokuz Eylul University Faculty of Nursing
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ilkin Yilmaz, PhD
Organizational Affiliation
Dokuz Eylul University Faculty of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share the patients data with other researchers.

Learn more about this trial

Effects of Open and Closed System Suctioning on Suctioning Frequency and Amount of Secretion

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