Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000075482
Ethics application status
Approved
Date submitted
5/09/2015
Date registered
22/01/2016
Date last updated
22/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Positive End-Expiratory Pressure on Cross-Sectional Area of Internal Jugular Vein in Obese Patients
Scientific title
The effect of the positive end expiratory pressure on the change in size of the right internal jugular vein to exhibit optimal position for internal jugular vein catheterization in preoperative, mechanically ventilated obese patients.
Secondary ID [1] 287325 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obese patients undergoing elective surgery under endotracheal intubation will be included in this random, prospective, clinical study 295963 0
Condition category
Condition code
Diet and Nutrition 297266 297266 0 0
Obesity
Anaesthesiology 297527 297527 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
72 obese adult patients (BMI>30 kg/m2) with ASA status II-III between 18 and 65 years age old who were scheduled for elective surgery under general anesthesia were enrolled in the study. In the operating room all patients recevied a balanced hydroxyethyl starch solution, (HES 130/0.4/6%; Voluven, Fresenius Kabi),6 ml/kg of the calculated ideal body weight (IBW), over 15 minute before induction of anesthesia. All anaesthetics administered were given as part of standard care. Anesthesia was induced with propofol 1.5-2.5 mg/kg of lean body weight(LBW) and fentanil 2-3 mcg/kg of LBW and rocuronium 0.6-1.2 mg/kg of IBW. Anesthesia was maintained with sevoflurane in air:oxygen mixture (50: 50) to keep a target MAC of 0.8 during the image recordings and data collection to reduce possible hypotension due to anesthesia without surgical stimulation. Lungs were ventilated in a volume-controlled mode with tidal volume of 7 ml/kg IBW. All of the measurements were performed in <20degree contralateral neck rotation. The cross-sectional area (CSA) of right internal jugular vein (IJV) measured at the level of the cricoid cartilage using a two-dimensional ultrasound machine with a 10-MHz linear probe (Mindray M5 'Registered Trademark, Shenzhen). Probe was placed perpendicular to the skin with minimal pressure to ensure that the examined vein was not compressed. While the probe was held in the proper position an investigator manipulated the ventilator 3 different conditions according to the order of the randomly assigned sequence:
1-a baseline condition without Positive end-expiratory pressure (PEEP) (P0),
2-a PEEP of 5 cm H2O(P5),
3-a PEEP of 12 cm H2O(P12).
Randomization was achieved using the Orthoganol Latin Square Design method. Each PEEP condition is administered for one minutes and the ultrasound images were obtained at least 3 seconds after instituting each maneuver for 10 seconds. Images capture timing of the study was considered as a washout time. The same practitioner performed all ultrasound examinations. Following measurements were calculated at each condition using preloaded software installed in the ultrasound machine by an independent observer who was blinded to the study protocol;
1-CSA of the right IJV,
2-Transvers diamater(TD) and anteroposterior diameter(APD) of the IJV,
3-Margin of safety(MOS)(defined as the distance from the lateral most border of the IJV and the lateral-most border of the carotid artery(CA) at which the IJV could be punctured without touching the CA).
4-Depth of the IJV from the skin(measured by drawing a line between the skin and the closest margin of the vein to the skin’s surface),
5-Degree of overlap(categorized on the basis of the percentage of overlap;
1- 0%(no overlap);
2- IJV overlapped<25% of the diameter of the CA;
3- IJV overlapped 25–50% of the diameter of the CA;
4- IJV overlapped>50% of the diameter of the CA.
Intervention code [1] 292773 0
Treatment: Surgery
Intervention code [2] 292774 0
Treatment: Other
Comparator / control treatment
Different PEEP values; 0, 5 and 12 cm H2O PEEP levels. PEEP 0 will act as the control arm.
Control group
Active

Outcomes
Primary outcome [1] 296035 0
The primary aim of this study was to investigate changes in CSA of the right IJV during different PEEP levels in anesthetized obese patients using ultrasound..
Timepoint [1] 296035 0
Image records were obtained after induction of anesthesia and before surgical start. CSA measurements were performed later from recorded images
Secondary outcome [1] 317305 0
The secondary outcome measure was the transverse diameter of the right IJV at 0 cm H2O PEEP, 5 cm H2O and 12 cm H2O PEEP levels. Transverse diameter assessed using ultrasound.
Timepoint [1] 317305 0
Image records were obtained after induction of anesthesia and before the surgical start. Transverse diameter measurements were performed later from recorded images
Secondary outcome [2] 319531 0
The secondary outcome measure was the anteroposterior diameter of the right IJV at 0 cm H2O PEEP, 5 cm H2O and 12 cm H2O PEEP levels. Anteroposterior diameter assessed using ultrasound.
Timepoint [2] 319531 0
Image records were obtained after induction of anesthesia and before the surgical start. Anteroposterior diameter measurements were performed later from recorded images
Secondary outcome [3] 319532 0
The secondary outcome measure was the overlap between the right IJV and carotid artery at 0 cm H2O PEEP, 5 cm H2O and 12 cm H2O PEEP levels which assessed using ultrasound.
Timepoint [3] 319532 0
Image records were obtained after induction of anesthesia and before the surgical start. The overlap between the right IJV and carotid artery measurements were performed later from recorded images
Secondary outcome [4] 319533 0
The secondary outcome measure was the margin of the safety at 0 cm H2O PEEP, 5 cm H2O and 12 cm H2O PEEP levels which assessed using ultrasound.
Timepoint [4] 319533 0
Image records were obtained after induction of anesthesia and before the surgical start. The margin of the safety measurements were performed later from recorded images

Eligibility
Key inclusion criteria
Obese adult patients (body mass index >30 kg/m2) with American Society of Anesthesiologists(ASA) status II-III between 18 and 65 years age old who were scheduled for elective surgery under general anesthesia were enrolled in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were as follows, previous IJV cannulation, thrombosis of IJV, anatomical neck abnormalities, uncontrolled hypertension and diabetes, congestive heart failure, valvular heart disease, chronic obstructive pulmonary disease, pulmonary hypertension. Patients who experienced severe hypotension (mean arterial blood pressure (MAP) of 30% below the baseline value) and bradycardia (heart rate (HR) below 45 beats per min) after induction of anesthesia and/or during the ultrasound measurements were excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer-generated randomization codes were prepared and provided to investigators in sequentially numbered sealed opaque envelopes before induction of general anaesthesia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomization codes were prepared and provided to investigators in sequentially numbered sealed opaque envelopes before induction of general anaesthesia.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/01/2015
Date of last participant enrolment
Anticipated
Actual
7/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 7145 0
Turkey
State/province [1] 7145 0

Funding & Sponsors
Funding source category [1] 291989 0
Hospital
Name [1] 291989 0
Konya Training and Research Hospital
Country [1] 291989 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] 290653 0
None
Name [1] 290653 0
Address [1] 290653 0
Country [1] 290653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293482 0
Selcuk University Institutional Review Board
Ethics committee address [1] 293482 0
Ethics committee country [1] 293482 0
Turkey
Date submitted for ethics approval [1] 293482 0
17/11/2014
Approval date [1] 293482 0
22/12/2014
Ethics approval number [1] 293482 0
B.30.2.SEL.0.28.00.00/130

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

Contacts
Principal investigator
Name 59722 0
Dr Betul Kozanhan
Address 59722 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya Postcode:42090
Country 59722 0
Turkey
Phone 59722 0
+90 332 221 00 00
Fax 59722 0
Email 59722 0
[email protected]
Contact person for public queries
Name 59723 0
Seza Apiliogullari
Address 59723 0
Selcuk University Faculty of Medicine Department of Anesthesiology and Reanimation Postalcode:42250
Selcuklu/Konya/TURKEY
Country 59723 0
Turkey
Phone 59723 0
+90 332 223 6000
Fax 59723 0
Email 59723 0
[email protected]
Contact person for scientific queries
Name 59724 0
Seza Apiliogullari
Address 59724 0
Selcuk University Faculty of Medicine Department of Anesthesiology and Reanimation Postalcode:42250
Selcuklu/Konya/TURKEY
Country 59724 0
Turkey
Phone 59724 0
+90 332 223 6000
Fax 59724 0
Email 59724 0
[email protected]

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
No additional documents have been identified.