Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction

December 12, 2019 updated by: Gulay ALTUN UGRAS, Mersin University

The Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction in Cardiovascular Surgery Intensive Care Patients

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.

Study Overview

Detailed Description

Information collected from the relatives of the patient, patient file and the health care workers was used to fill out the "Patient Information Form".

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.

When the findings of patients' suction needs were observed (increase in respiratory rate, HR increase, arterial BP increase, high pressure alarm in ventilator, mucus in ET, cyanosis, dyspnea, restlessness, sweating, disturbance of blood gas parameters, wheezing, etc.), endotracheal suction was performed according to the application standards. 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.

During the suction process, it was ensured that the patients were in the supine position in which the head of the bed was lifted by 30 degree Before the intra-arterial BP was measured, the transducer was reset at the level of the right atrial (plebostatic axis) and the position was not changed during all the measurements.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • postcardiac surgery
  • having endotracheal tube

Exclusion Criteria:

- pulmonary problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ET fixation with ET holder
ET fixation of the patients in the study group was performed with an ET holder when they arrived at the CVS ICU

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.

No Intervention: ET fixation with plaster
ET fixation in the control group was performed with plasters, which are routinely used in the ICU where the study was conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: During the suction process
systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg
During the suction process
Heart rate
Time Frame: During the suction process
beats per minute
During the suction process
peripheral oxygen saturation
Time Frame: During the suction process
%, percentage of oxygenated hemoglobin in peripheral arterial blood
During the suction process

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Gülay Altun Ugras (Other Identifier: MersinU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

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