Other Disorders of the Eye Following Cataract SurgeryNCT03923283
The Measurements of End-tidal Carbondioxide Levels
An observational study of Other Disorders of the Eye Following Cataract Surgery, run by Duzce University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Other Disorders of the Eye Following Cataract Surgery
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 was collected.
Who may be able to join
- 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 .
Who cannot join
- Patients with chronic obstructive pulmonary disease, diabetes mellitus and sedative usage were excluded from the study.
About this study
Official title: End-tidal Carbondioxide Levels Under Surgery Drapes During Local Eye Surgery: Retrospective Study
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.
Read more
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.
Read the detailed 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.
- Keywords
- End-tidal carbondioxide, surgery drapes, carbondioxide accumulation, eye surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Other Disorders of the Eye Following Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Suidiye, Duzce University
- Investigators
- Ilknur S Yorulmaz, Principal investigator, Duzce University Faculty Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923283
- Sponsor's protocol ID
- Duzce University
- Status last verified
- Apr 2019
- First submitted
- 5 Jun 2017
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28177116Allen 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.
PubMed 26502459Howarth 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.
PubMed 28137973Weeke 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.
PubMed 28130246Courtney P. The National Cataract Surgery Survey: I. Method and descriptive features. Eye (Lond). 1992;6 ( Pt 5):487-92. doi: 10.1038/eye.1992.103.
PubMed 1286712Report of the Joint Working Party on anesthesia in Ophthalmic Surgery. Royal Collage of Anaesthetists and Collage of Ophthalmologists, March (1993).
Jerusalem E, Starling EH. On the significance of carbon dioxide for the heart beat. J Physiol. 1910 May 13;40(4):279-94. doi: 10.1113/jphysiol.1910.sp001370. No abstract available.
PubMed 16993008
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-tidal Carbondioxide Levels Under Surgery Drapes During Local Eye Surgery: Retrospective Study
- ClinicalTrials.gov ID
- NCT03923283
- Acronym / sponsor ID
- Duzce University
- Keywords
- End-tidal carbondioxide, surgery drapes, carbondioxide accumulation, eye surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 was collected.
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (1 listed)
- Patients with chronic obstructive pulmonary disease, diabetes mellitus and sedative usage were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Measurements of End-tidal Carbondioxide Levels Under Surgery Drapes During Local Eye Surgery
Time frame: 1 hour
To determine the difference between capnostream capnography and carbon dioxide levels measured at various times in patients undergoing eye surgery under local anesthesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Background: PubMed 28177116Dinsmore 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.
- Background: PubMed 26502459Allen 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.
- Background: PubMed 28137973Howarth 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.
- Background: PubMed 28130246Weeke 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.
- Background: PubMed 1286712Courtney P. The National Cataract Surgery Survey: I. Method and descriptive features. Eye (Lond). 1992;6 ( Pt 5):487-92. doi: 10.1038/eye.1992.103.
- BackgroundReport of the Joint Working Party on anesthesia in Ophthalmic Surgery. Royal Collage of Anaesthetists and Collage of Ophthalmologists, March (1993).
- Background: PubMed 16993008Jerusalem E, Starling EH. On the significance of carbon dioxide for the heart beat. J Physiol. 1910 May 13;40(4):279-94. doi: 10.1113/jphysiol.1910.sp001370. No abstract available.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilknur S Yorulmaz principal investigator
Duzce University Faculty Of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Other Disorders of the Eye Following Cataract Surgery, run by Duzce University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Measurements of End-tidal Carbondioxide Levels Under Surgery Drapes During Local Eye Surgery (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03923283, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.