Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction
The Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction in Cardiovascular Surgery Intensive Care Patients
1 other identifier
interventional
86
0 countries
N/A
Brief Summary
Background: Endotracheal suction (ES), may cause changes like increase in blood pressure, heart rate (HR) and decrease in peripheral oxygen saturation (SpO2), which may cause changes in hemodynamic parameters (HPs) that increase the workload of the heart after surgery. Aim: The aim of this study is to determine the effect of the methods used in endotracheal tube (ET) fixation on HPs \[systolic blood pressure (SBP), diastolic blood pressure (DBP), HR and SpO2\] during ES. Study Design: The sample of this prospective, single-blind non-randomized clinical trial study included 86 intubated patients who were treated in the cardiovascular surgery intensive care unit (CVSICU) of a university hospital between September 2016 and December 2017. Methods: The ET fixations of the experimental group (n=43) were performed with tube holders while the ET fixations of the control group (n=43) were performed using plasters. The HPs of the patients were measured before, during, at the end of suction and 5 and 15 minutes after suction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
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
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 10, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedDecember 13, 2019
December 1, 2019
1.2 years
December 10, 2019
December 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Blood pressure
systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg
During the suction process
Heart rate
beats per minute
During the suction process
peripheral oxygen saturation
%, percentage of oxygenated hemoglobin in peripheral arterial blood
During the suction process
Study Arms (2)
ET fixation with ET holder
EXPERIMENTALET fixation of the patients in the study group was performed with an ET holder when they arrived at the CVS ICU
ET fixation with plaster
NO INTERVENTIONET fixation in the control group was performed with plasters, which are routinely used in the ICU where the study was conducted.
Interventions
When the study started, the first 43 patients were assigned to the control group and the following 43 patients were assigned to the study group in the CVS ICU. ET fixation in the control group was performed with plasters, which are routinely used in the ICU where the study was conducted. ET fixation of the patients in the study group was performed with an ET holder (AnchorFast Oral Endotracheal Tube Fastener, Hollister, Liberlyville, USA) when they arrived at the CVS ICU. The patients' SBP, DBP, HR and SpO2 values, which were displayed on the bedside monitor (Nihon Kohden, Tokyo), were recorded on the "Hemodynamic Parameters Form" just before, during, and at the end of endotracheal suction, and in the following 5th and 15th minutes.
Eligibility Criteria
You may qualify if:
- postcardiac surgery
- having endotracheal tube
You may not qualify if:
- \- pulmonary problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- In this study only the patient was blinded. Investigators involved with the running of the study were not blinded.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 10, 2019
First Posted
December 13, 2019
Study Start
September 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 13, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share