NCT04454931

Brief Summary

In order for the brain, which is the most metabolically active organ of our body, to maintain its functions, it must reach oxygen saturation in the best way with continuous and rich blood flow. Neurosurgery patients are followed for a while in the intensive care unit with a mechanical ventilator. During the care of the patient in mechanical ventilation; position changes, head height, endotracheal aspiration, oral care and invasive procedures that cause painful stimuli to the patient are factors that can affect brain perfusion pressure and oxygenation status of brain cells. It is known that high intracranial pressure, especially during and after endotracheal aspiration application, causes serious conditions in patients by disrupting cerebral blood flow. It is also seen that cerebral blood flow is associated with head and body positions given in the postoperative period. It is stated in the literature that neurosurgical patients should be 30-45 degrees for proper head height in bed. In these patients, the height of the head should be in a suitable position for the correction of cerebral blood flow, which deteriorates during endotracheal aspiration, since autoregulation mechanisms are impaired or always activated. However, when the literature is examined, no information about the ideal head height that should be given to patients during endotracheal aspiration was found. In addition, one of the most important parameters indicating the presence of cerebral complications is monitoring of cerebral oxygenation. It is stated that the most appropriate follow-up for patients should be evaluated by nurses in a non-invasive method. In this study; In neurosurgery intensive care patients, endotracheal aspiration will be applied during endotracheal aspiration at head heights of 15, 30 and 45 degrees and it is aimed to determine the most appropriate head height during and after application by monitoring non-invasive cerebral oximeter device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

March 4, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

March 4, 2020

Last Update Submit

November 5, 2021

Conditions

Keywords

neurosurgery patientendotracheal suctioningnursing carecerebral oxygenationoptimal head height

Outcome Measures

Primary Outcomes (1)

  • To monitor the change of endotracheal suctioning in cerebral oxygenation parameter with non-invasive monitor in neurosurgery intensive care patients and to look at the statistical significance of the change.

    Preservation of neurosurgical patients' cerebral perfusion is very important for the prognosis of patients. It is known that endotracheal aspiration,which is one of the nursing care practices applied in the intensive care follow-up of these patients,impairs the cerebral perfusions.However, although it is known, it is not sufficient to monitor the parameters showing the srebral perfusion status by the nurses who are constantly present with the patient.This parameter will be monitored with the regional oximeter device,which is considered to be the most accurate and appropriate method during and after endotracheal aspiration,which is one of the applications that change the cerebral perfusion status the most.In the literature, follow-up up to 30 minutes was planned, as the time required to correct cerebral perfusion was reported as 30 minutes in these patients

    The measurement will start with recording the value before the endotracheal suctıonıng application and end with recording the value at 30 minutes after the application. Results will be determined after reporting at the end of 1 year.

Secondary Outcomes (5)

  • To look at the effect of using technology for early diagnosis of complications such as cerebral ischemia in neurosurgery intensive care patients.

    1 year

  • To determine the effect of endotracheal aspiration on 15% head height in cerebral oxygenation in neurosurgery intensive care patients.

    1 year

  • To determine the effect of endotracheal aspiration procedure applied at 30 degree head height on the percentage of cerebral oxygenation in neurosurgery intensive care patients.

    1 year

  • To determine the effect of endotracheal aspiration on 45% head height in cerebral oxygenation in neurosurgery intensive care patients.

    1 year

  • The effect of age,gender,diagnosis, number of hospitalization days,mechanical ventilatory mode, glaskow coma scale score variables on patients' cerebral oxygenation before and after endotracheal suctionıng in patients with mechanical ventilation

    1 year

Study Arms (1)

Intensive care patients who underwent neurosurgery

Cerebral oxygenation status will be monitored during and after endotracheal suctioning in each patient included in the study. Non-invasive regional oximetry probes are placed in the frontal region of the patient and the patient will be positioned at the head height of 15 degrees with a 3-motor angle determining bearing system. Then, when the patient's need for endotracheal suctioning arises, endotracheal suctioning will be performed and the cerebral oxygenation status before the procedure, 1 minute, 5 minutes and 30 minutes after the procedure will be recorded on the monitor of the non-invasive regional oximeter device operating with NIRS technology. The same procedure will be applied to the patient at head heights of 30 and 45 degrees. Cerebral oxygenation status measured at each head height will be compared with appropriate statistical methods and the most appropriate head height will be determined.

Device: Root® with O3® Regional Oximetry

Interventions

May help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain. It was aimed to determine the appropriate head height that should be given to patients in order to correct the endotracheal suctioning sequence, which is the most important care application of the neurosurgery patients who are followed up in the intensive care unit after surgery, and the possibility of subsequent disruption of cerebral perfusion. Therefore, cerebral oxygenation status, which is the most important parameter that shows the cerebral perfusion status of patients during and after the application, will be followed up by nurses with a non-invasive cerebral oximeter device.

Intensive care patients who underwent neurosurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Turkey linked to the Health Ministry in the Western Black Sea Region Zonguldak Ataturk State Hospital intensive care unit treatment and care made postoperative mechanical ventilation due to brain surgery all the patient population of the study (according to information from the hospital's information-processing unit 01.01.2018- An average of 520 patients underwent brain surgery between 31.12.2018). The sample of the research, according to the research results obtained from the literature; α = 0.05, 0.25 effect size was determined as 46 patients with 90% power. The research was designed to make repeated measurements in a single group. Patients who meet the inclusion criteria will be included in the study.

You may qualify if:

  • Having undergone neurosurgery surgery,
  • To get mechanical ventilator support,
  • To have completed at least 6 hours in the mechanical ventilator, but not yet in the 72 hours,
  • Being at the age of 18 and over,
  • Life signs are stable (arterial blood pressure 160/90 mmHg; heart rate 70-100 / min, respiratory rate 16-20 / min, body temperature 36-37.5 ° c) and no pulmonary problems, Oxygen saturation level measured by pulse oximeter to be 85% and above,
  • Glaskow Coma Score (GKS) not being below 9E,
  • Na +, K +, Cl-, Hb, Hct values are within the normal reference range,
  • Not having contraindications for head and body positioning,
  • Volunteering to participate in the research.

You may not qualify if:

  • Having another surgery apart from neurosurgery surgery,
  • Not getting mechanical ventilator support,
  • The time spent in the mechanical ventilator is less than 6 hours and more than 72 hours,
  • Being under the age of 18,
  • Life signs are unstable and have a pulmonary problem,
  • Oxygen saturation level measured by pulse oximetry below 85%
  • To be under Glaskow Coma Score (GKS) 9E,
  • Na +, K +, Cl-, Hb, Hct values should not be within the normal reference range,
  • Being a contraindication case for head and body positioning,
  • Not to volunteer to participate in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zonguldak Bülent Ecevit University Health Practice and Research Hospital

Zonguldak, Kozlu, Turkey (Türkiye)

Location

Zonguldak Atatürk State Hospital

Zonguldak, Meşrutiyet, 67100, Turkey (Türkiye)

Location

Study Officials

  • Zonguldak Bülent Ecevit University Faculty of Health Sciences

    Zonguldak Bülent Ecevit University Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 4, 2020

First Posted

July 2, 2020

Study Start

April 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

November 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

All data ready to be published as a result of the research will be shared.

Time Frame
It will be available once the research is complete and ready for publication. There is no limit for the date of access.
Access Criteria
Completion and reporting of the study

Locations