The Effects of Positive End-Expiratory Pressure on Cross-Sectional Area of Internal Jugular Vein in Obese Patients

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000075482
• Date of registration: 22/01/2016
• Prospective Registration: No
• Primary sponsor: Konya Training and Research Hospital
• 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.
• Date of first enrolment: 29/01/2015
• Target sample size: 72
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000075482.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Turkey

Contacts

• Name: Dr Seza Apiliogullari

• Name: A/Prof Seza Apiliogullari

Key inclusion & exclusion criteria

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.
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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Obesity

Anaesthesiology - Other anaesthesiology

Obese patients undergoing elective surgery under endotracheal intubation will be included in this random, prospective, clinical study;
Obese patients undergoing elective surgery under endotracheal intubation will be included in this random, prospective, clinical study

Intervention(s)

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

Primary Outcome(s)

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.. [Image records were obtained after induction of anesthesia and before surgical start. CSA measurements were performed later from recorded images]

Secondary Outcome(s)

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.[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]

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.
[Image records were obtained after induction of anesthesia and before the surgical start. Anteroposterior diameter measurements were performed later from recorded images]

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.[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]

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.
[Image records were obtained after induction of anesthesia and before the surgical start. Transverse diameter measurements were performed later from recorded images]

Secondary ID(s)

nil

Source(s) of Monetary Support

Konya Training and Research Hospital

Ethics review

Status: Approved
Approval date:
Contact:

Selcuk University Institutional Review Board