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Completed

NCT Number: NCT04199039

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • postcardiac surgery
  • having endotracheal tube

Exclusion criteria

  • pulmonary problems

Treatment and study plan

Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction

Other

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.

Primary outcomes

  1. Blood pressure

    Time frame: During the suction process

    systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg

  2. Heart rate

    Time frame: During the suction process

    beats per minute

  3. peripheral oxygen saturation

    Time frame: During the suction process

    %, percentage of oxygenated hemoglobin in peripheral arterial blood

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2019
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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