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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03923283
Other study ID # Duzce University
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2016

Study information

Verified date April 2019
Source Duzce University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Purpose: The aim of this retrospective study is to investigate the end tidal carbon dioxide pressure (ETCO2) values in order to determine the carbon dioxide accumulation under drape and to investigate it's hemodynamic effects based on anesthetic and surgical records in eye surgeries under local anesthesia.

Methods: The data were collected from anesthetic records of the patients who were followed with noninvasive capnograph (Capnostream 20 p, Oridion®, Israel) by the anesthesiology department in the operating room at Duzce University Faculty of Medicine Hospital during the period of January 2016 to December 2016.

Collected data from the 42 patients' records were systolic, diastolic and mean arterial pressures, operation duration, total local anesthetic and, heart rate, ST segment analysis, ETCO2 pressure, pulse oximeter values.

The time periods of collected datas were determined as: after the anesthesia and before drape closure (baseline level), at 10th, 15th, 20th, 45th of the surgery and 5 minutes after drape removal.


Description:

After approval from the Duzce Faculty of Medicine Noninvasive Researches Ethics Committee (02.01.2017), the datas were collected patients anesthetic forms who were followed with capnograph (Capnostream 20 p, Oridion, Israel) by the anesthesiology department for eye surgery in the operating room at Duzce University Faculty of Medicine Hospital during the period of 01 January 2016 to 31 December 2016. It was observed that 42 patient records met the study criteria. Demographic and clinical datas were abstracted from anesthetic and clinical records.

Age, weight, height of the patients, operation types, operation duration times, local anesthetic performing types, noninvasive systolic, diastolic and mean arterial pressures, cardiac rates, ST segment analysis (Datex Ohmeda monitor, GE Health Care, Finland) ( This monitor use for the routine monitorisation in the eye surgery operating room in our hospital) systolic, diastolic and mean arterial pressure measurements, end tidal carbon dioxide levels, pulse oximeter values were extracted from anesthetic forms retrospectively.

Arrhythmia recordings were evaluated as (yes / no) over time periods. Surgical field was covered with reusable cotton fabric drape or dispossible surgical adhesive plastic drape (SteriDrape, 3M). We included the patients records who were covered with the same kind of drapes (SteriDrape, 3M). We excluded records with another type of drapes usage or without any data about drape type to provide the homogenisation and clearity of the results.

Datas were collected from the anesthetic forms which time periods were determined as the baseline, before closing drape, at 10th, 15th, 20th, 45th minutes after covering and 5 minutes after drape removal. Records with pulmonary disease, diabetes mellitus and sedative usage, alcohol usage were excluded from the study.

The comparisons were made with patients basal status and time periods statistically.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Datas were collected after approval from the Duzce Faculty of Medicine Noninvasive Researches Ethics Committee (02.01.2017), the datas of the patients who were followed with capnograph (Capnostream 20 p, Oridion, Israel) by the anesthesiology departhment in the operating room at Duzce University Faculty of Medicine hospital during the period of January 2016 to December 2016 .

Exclusion Criteria:

- Patients with chronic obstructive pulmonary disease, diabetes mellitus and sedative usage were excluded from the study.

Study Design


Related Conditions & MeSH terms

  • Cataract
  • Other Disorders of the Eye Following Cataract Surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Duzce University

References & Publications (7)

Allen JG, MacNaughton P, Satish U, Santanam S, Vallarino J, Spengler JD. Associations of Cognitive Function Scores with Carbon Dioxide, Ventilation, and Volatile Organic Compound Exposures in Office Workers: A Controlled Exposure Study of Green and Conventional Office Environments. Environ Health Perspect. 2016 Jun;124(6):805-12. doi: 10.1289/ehp.1510037. Epub 2015 Oct 26. — View Citation

Courtney P. The National Cataract Surgery Survey: I. Method and descriptive features. Eye (Lond). 1992;6 ( Pt 5):487-92. — View Citation

Dinsmore M, Han JS, Fisher JA, Chan VW, Venkatraghavan L. Effects of acute controlled changes in end-tidal carbon dioxide on the diameter of the optic nerve sheath: a transorbital ultrasonographic study in healthy volunteers. Anaesthesia. 2017 May;72(5):618-623. doi: 10.1111/anae.13784. Epub 2017 Feb 8. — View Citation

Howarth C, Sutherland B, Choi HB, Martin C, Lind BL, Khennouf L, LeDue JM, Pakan JM, Ko RW, Ellis-Davies G, Lauritzen M, Sibson NR, Buchan AM, MacVicar BA. A Critical Role for Astrocytes in Hypercapnic Vasodilation in Brain. J Neurosci. 2017 Mar 1;37(9):2403-2414. doi: 10.1523/JNEUROSCI.0005-16.2016. Epub 2017 Jan 30. Erratum in: J Neurosci. 2017 May 3;37(18):4860. — View Citation

Jerusalem E, Starling EH. On the significance of carbon dioxide for the heart beat. J Physiol. 1910 May 13;40(4):279-94. — View Citation

Report of the Joint Working Party on anesthesia in Ophthalmic Surgery. Royal Collage of Anaesthetists and Collage of Ophthalmologists, March (1993).

Weeke LC, Dix LML, Groenendaal F, Lemmers PMA, Dijkman KP, Andriessen P, de Vries LS, Toet MC. Severe hypercapnia causes reversible depression of aEEG background activity in neonates: an observational study. Arch Dis Child Fetal Neonatal Ed. 2017 Sep;102(5):F383-F388. doi: 10.1136/archdischild-2016-311770. Epub 2017 Jan 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Measurements of End-tidal Carbondioxide Levels Under Surgery Drapes During Local Eye Surgery To determine the difference between capnostream capnography and carbon dioxide levels measured at various times in patients undergoing eye surgery under local anesthesia. 1 hour