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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04199039
Other study ID # Gulay altun ugras
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date December 2017

Study information

Verified date December 2019
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- postcardiac surgery

- having endotracheal tube

Exclusion Criteria:

- pulmonary problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Outcome

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