Cardiac SurgeryNCT04199039
Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction
A study testing Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction in people with Cardiac Surgery, run by Mersin University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postcardiac surgery
- having endotracheal tube
Who cannot join
- pulmonary problems
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction
- Keywords
- endotracheal tube, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal SuctionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg
Measured: During the suction process
Heart rate
beats per minute
Measured: During the suction process
peripheral oxygen saturation
%, percentage of oxygenated hemoglobin in peripheral arterial blood
Measured: During the suction process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study startSep 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, single-blind non-randomized clinical trial study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ALTUN UGRAS, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199039
- Sponsor's protocol ID
- Gulay altun ugras
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction in Cardiovascular Surgery Intensive Care Patients
- ClinicalTrials.gov ID
- NCT04199039
- Acronym / sponsor ID
- Gulay altun ugras
- Conditions
- Cardiac Surgery
- Keywords
- endotracheal tube, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, single-blind non-randomized clinical trial study
| Arm | Type | Receives |
|---|---|---|
| ET fixation with ET holder | Experimental | Other: Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal SuctionET 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 intervention | –ET fixation in the control group was performed with plasters, which are routinely used in the ICU where the study was conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- postcardiac surgery
- having endotracheal tube
Key exclusion criteria (1 listed)
- pulmonary problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal SuctionWhen 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. | Other | ET fixation with ET holder |
Primary outcome
Blood pressure
Time frame: During the suction process
systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg
Heart rate
Time frame: During the suction process
beats per minute
peripheral oxygen saturation
Time frame: During the suction process
%, percentage of oxygenated hemoglobin in peripheral arterial blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction in people with Cardiac Surgery, run by Mersin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: During the suction process). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.