NCT04199039

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Status
completed

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

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

December 10, 2019

Last Update Submit

December 12, 2019

Conditions

Keywords

endotracheal tubenursing

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

EXPERIMENTAL

ET fixation of the patients in the study group was performed with an ET holder when they arrived at the CVS ICU

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

ET fixation with plaster

NO INTERVENTION

ET 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.

ET fixation with ET holder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
Model Details: prospective, single-blind non-randomized clinical trial study
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