the Effect of Different Mechanical Ventilation Modes on Optic Nerve Diameter and Conscious Functions

The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations

During surgery, researchers use different methods in respiratory equipment. In the study researchers examine the effects of these methods on intraocular pressure changes by looking at the intraocular nerve diameter. Then look at the effects of these effects on patients conscious functions by asking some questions.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Procedure: The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations

Detailed Description

According to the mechanical ventilator application to be applied to the patients; Group P (n: 30) pressure controlled ventilation (PCV), Group V (n: 30) volume controlled ventilation (VCV) are randomly assigned to two groups. General anesthesia will be applied to all patients. Mechanical ventilation settings will be able to 8ml / kg TV (tidal volume). Demographic data (age, gender, weight, height) of patients, duration of surgery and peroperative complications will be recorded choosen time intervals.T0: awake, T1: 5th min after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is reached in reverse trendelenburg position, T4:Before extubation. SAB, DAB, OAB, KAH, SpO2, Ppeek, PEEP, EtCO2, optic nerve diameter will be recorded at same times. Cognitive function test will be performed at postoperative 24th hour for comparing the first awaken routin MMDT (Mini Mental Status Detection) scale. The same test will be repeated for patients who are called for routine general surgery outpatient control 3 months after surgery.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 60160
    • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-II
• 18-65 years old

Exclusion Criteria:

• Unable to cooperate
• Presence of eye disease (detachment, retinapathy, glaucoma)
• Presence of a previous eye operation
• Those with symptoms of KIBAS (intracranial pressure increase syndrome) (Intracranial lesion, previous cerebrovascular diseases)
• BMI (body mass index> 40 kg / m2
• Obstructive and restrictive lung disease
• Pulmonary Hypertension
• Congestive Heart Failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pressure controlled ventilation, Volum controlled ventilation; Undergoing laparoscopic cholecystectomy surgery according to mechanical ventilator mode; Group P (n: 30) Pressure controlled ventilation was randomly divided into Group V (n: 30) volume controlled ventilation settings were adjusted to be 50% O2- 50% air, 8ml / kg TV (tidal volume) and PEEP 5.	Procedure: The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations; The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations
Active Comparator: Optic Nerve Sheath Diameter; In optic nerve diameter measurements; A layer of water-soluble sterile gel was applied to the closed upper eyelid. The linear 10-5 MHz ultrasound probe was carefully placed on the upper eyelid over the gel. The entrance of the optic nerve to the orbital globe in 2D mode was displayed on the monitor without applying too much pressure. After finding the optimal contrast between the retrobulbar echogenic fat tissue and vertical hypoechoic band 23, the diameter of the optic nerve sheath was measured 3 mm behind the optic disc using an electronic caliper.	Procedure: The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations; The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optic nerve sheath diameter (milimeter)	Optic nerve sheath diameter; It was measured from the optic nerve sheath 3 mm behind the optic disc from the closed upper eyelid. T0: Awake, T1: 5th minute after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is reached in reverse trendelenburg position, T4: Before extubation in supine position. A typical optic nerve sheath is generally less than 5 mm in diameter and diameters greater than 5.5 mm predict an ICP of >20 cmH2O .	2 hours operation time
Cognitive Function	Cognitive function test with Mini Mental Conditioning Scale was performed to the patients before the anesthesia induction and 3 months after the surgery . Mini Mental Scale points are between 0 and 30.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peroperative Complications	Complications during the surgery (hypercapnia, hypotension,hypertension,rythm disorder) were recorded.	2 hours operation time

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Study Chair: Tugba Onur, MD, BYIEAH; Study Chair: Korgun Okmen, MD, BYIEAH; Study Chair: Serkan Terkancıoglu, MD, BYIEAH; Study Chair: Gorkem Cevik, MD, BYIEAH

Publications and helpful links

General Publications

• Karaca U, Onur T, Okmen K, Terkanlioglu S, Cevik G, Ata F. Effect of Various Modes of Mechanical Ventilation in Laparoscopic Cholecystectomies on Optic Nerve Sheath Diameter and Cognitive Functions. J Laparoendosc Adv Surg Tech A. 2021 Jul;31(7):808-813. doi: 10.1089/lap.2020.0866. Epub 2020 Dec 11.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Optic Nerve Sheath Diameter,; Minimental test
• Other Study ID Numbers: 2017-17/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No