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

NCT04413903 | Completed

• 1 other identifier: 2017-17/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation

Keywords

Optic Nerve Sheath Diameter,; Minimental test

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Peroperative Complications

  2 hours operation time

Study Arms (2)

Pressure controlled ventilation, Volum controlled ventilation

ACTIVE COMPARATOR

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

Optic Nerve Sheath Diameter

ACTIVE COMPARATOR

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

Interventions

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

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

Optic Nerve Sheath Diameter; Pressure controlled ventilation, Volum controlled ventilation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, 60160, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33306936 DERIVED

Study Officials

• Tugba Onur, MD

  BYIEAH

  STUDY CHAIR

• Korgun Okmen, MD

  BYIEAH

  STUDY CHAIR

• Serkan Terkancıoglu, MD

  BYIEAH

  STUDY CHAIR

• Gorkem Cevik, MD

  BYIEAH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle İnvestigator

Model Details: ASA I-II 60 patients aged 18-65 years 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 50% air, PEEP 5 to 8ml / kg tidal volume.

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: June 4, 2020
• Study Start: December 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: October 31, 2018
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)