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Trial registered on ANZCTR


Registration number
ACTRN12614000806662
Ethics application status
Approved
Date submitted
14/07/2014
Date registered
30/07/2014
Date last updated
27/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of incrementally increasing tidal volume on the right internal jugular vein in pediatric patients
Scientific title
Effects of incrementally increasing tidal volume on the right internal jugular vein cross-sectional area and overlapping on carotid artery in pediatric patients and to exhibit optimal tidal volume under general anesthesia.
Secondary ID [1] 284972 0
nil
Universal Trial Number (UTN)
U1111-1159-0697
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
For central venous catheterization in the pediatric population which is most commonly used way of the right internal jugular vein under general anesthesia evaluation with different tidal volumes. 292475 0
Condition category
Condition code
Anaesthesiology 292785 292785 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty tree children between the ages of 7 and 12 yr, American Society of Anesthesiologists (ASA) physical status I and II, scheduled to undergo routine surgery under general endotracheal anesthesia, were studied. Patients with previous right internal juguler vein (IJV) catheterization, anatomical malformations of IJV, previous neck surgery, congenital heart disease, concurrent pulmonary disease that might influence the hemodynamics of the right heart, increased intracranial pressure, or preoperative hemodynamic instability were excluded from the present study. Fasting periods were in accordance with ASA guidelines.
Anesthesia was induced with propofol (3 to 5 mg/kg) and remifentanyl (0.5 mcg/kg), and endotracheal intubation (with an appropriately sized tracheal tube) was facilitated using rocuronium. After induction, volume- controlled mechanical ventilation (tidal volume adjusted to 6 and 10 mL/kg with no application of positive end expiratory pressure and respiratory rates were adjusted to achieve an end-tidal carbon dioxide of 30 to 35 mm Hg.) was initiated. Anaesthesia was maintained using sevoflurane 1–2% in an oxygen / air mixture.
Patients were placed in a supine position position with a roll under the center of the upper back to allow the head and the neck to be slightly extended. The size of the roll was adjusted to the children and not to be larger than the size of the neck. The head was positioned in a neutral position and then rotated 30 degrees to the contralateral side.
The right IJV cross-sectional area (CSA) and the anatomical relationship with the carotid artery were assessed using a two-dimensional ultrasound machine with a 10 MHz linear probe. The ultrasound probe was placed perpendicular to the skin, and images of the right IJV and carotid artery (CA) were collected at the level of the cricoid cartilage. The transducer was applied with minimal pressure to ensure that the vein was not compressed. This measurement was repeated after increasing the inspiratory volume in 1 ml/kg increments from a TV of 6 ml/kg to 10 ml/kg. To eliminate the respiratory effect, the investigator selected the image showing the largest CSA at the end-inspiratory phase of the 5th respiratory cycle at every tidal volume (TV) after freezing the image on the screen. Peak inspiratory pressure (PIP), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR), and end tidal carbon dioxide (EtCO2) were recorded at all TV levels. One investigator with more than 3 years experience handling the ultrasound machine captured all the images. All ultrasonography images were stored, and measurements were performed later by different blinded investigator .
On US images, the CSA of the right IJV were measured as previously described using a built in caliper. Transvers and sagittal diameter of the right IJV measured and the percentage overlap between the two vessels was calculated according to this formula [right IJV overlap of carotid artery (mm) / carotid artery diameter (mm)) × 100].
Intervention code [1] 289801 0
Treatment: Surgery
Comparator / control treatment
Different tidal volumes. Basale control group is 6 ml/kg inspiratory volume.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292636 0
Measurement was repeated after increasing the inspiratory volume in 1 ml/kg increments from a TV of 6 ml/kg to 10 ml/kg. CSA of RIJV is the primary outcome of this study. On US images, the CSA of the RIJV were measured as previously described using a built-in caliper. One investigator with more than 3 years experience handling the ultrasound machine captured all the images.
Timepoint [1] 292636 0
Image records were obtained after induction of anesthesia and surgical before the start. CSA measurements were performed later from recorded images.
Secondary outcome [1] 309393 0
Transvers and sagittal diameter of the right IJV.
Transvers and sagittal diameter of the right IJV measured using ultrasound .
Timepoint [1] 309393 0
Image records were obtained after induction of anesthesia and surgical before the start. Transvers and sagittal diameter of the right IJV were performed later from recorded images on ultrasound.
Secondary outcome [2] 309685 0
The percentage overlap between the two vessels. The percentage overlap between the two vessels was calculated according to this formula [right IJV overlap of carotid artery (mm) / carotid artery diameter (mm)) × 100].
Timepoint [2] 309685 0
Image records were obtained after induction of anesthesia and surgical before the start. The percentage overlap between the two vessels measurements were performed later from recorded images on ultrasound.

Eligibility
Key inclusion criteria
Children between the ages of 7-12 yr, ASA physical status I and II, scheduled to undergo routine surgery under general endotracheal anesthesia, were studied.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with previous right IJV catheterization, anatomical malformations of IJV, previous neck surgery, congenital heart disease, concurrent pulmonary disease that might influence the hemodynamics of the right heart, increased intracranial pressure, or preoperative hemodynamic instability were excluded from the present study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2014
Date of last participant enrolment
Anticipated
10/07/2014
Actual
11/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment outside Australia
Country [1] 6211 0
Turkey
State/province [1] 6211 0

Funding & Sponsors
Funding source category [1] 289592 0
Hospital
Name [1] 289592 0
Konya Training and Research Hospital
Country [1] 289592 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital,Clinic of Anesthesiology and Reanimation, 42090, Meram, Konya
Country
Turkey
Secondary sponsor category [1] 288276 0
None
Name [1] 288276 0
Address [1] 288276 0
Country [1] 288276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291327 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 291327 0
Ethics committee country [1] 291327 0
Turkey
Date submitted for ethics approval [1] 291327 0
07/05/2014
Approval date [1] 291327 0
14/05/2014
Ethics approval number [1] 291327 0
2014.73

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49874 0
Dr Mehmet SARGIN
Address 49874 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya

Postcode:42090
Country 49874 0
Turkey
Phone 49874 0
+905322662766
Fax 49874 0
Email 49874 0
mehmet21sargin@yahoo.com
Contact person for public queries
Name 49875 0
Sadik OZMEN
Address 49875 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya

Postcode:42090
Country 49875 0
Turkey
Phone 49875 0
+903322212250
Fax 49875 0
Email 49875 0
sadikozmen@hotmail.com
Contact person for scientific queries
Name 49876 0
Sadik OZMEN
Address 49876 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya

Postcode:42090
Country 49876 0
Turkey
Phone 49876 0
+903322212250
Fax 49876 0
Email 49876 0
sadikozmen@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of incrementally increasing tidal volume on the right internal jugular vein in pediatric patients.2015https://dx.doi.org/10.5301/jva.5000362
N.B. These documents automatically identified may not have been verified by the study sponsor.