Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000771257
Ethics application status
Approved
Date submitted
1/05/2018
Date registered
8/05/2018
Date last updated
8/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
We will investigate the ventilation method on the effect of eye nerve diameter during laparoscopic cholecystectomy.
Scientific title
Effect of positive end-expiratory pressure administration on diameter of the optic nerve sheet in laparascopic cholecystectomy
Secondary ID [1] 294804 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gall stones 307669 0
Condition category
Condition code
Anaesthesiology 306784 306784 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PEEP was implemented by an anesthesia assistant who was not included in the study and anesthesia researcher who does not know whether the patient is peeping or not peeping, measured optic nerve sheath diameter by ultrasound.
Group Peep: 10 cm H2O Peep administered during the operation (about one hour)
Group zero PEEP: no PEEP administered during the operation
The effect of 10 cm H2O PEEP on optic nerve sheet diameters measured by ultrasound
t1 = Before anesthesia induction
t2 = After entubation
t3 = Following pneumoperitoneum administration
t4 = After PEEP administration
t5 = After desuflation
t6 = Following extubation
Also, heart rate, mean arterial pressure, peak airway pressure, platau pressure were recorded at the same times
Intervention code [1] 301055 0
Other interventions
Comparator / control treatment
The patients were randomized into two groups with the sealed envelope method.

Zero PEEP group received no PEEP (C0mparator Group),
Participants in the comparator group will also have their nerve sheet diameter measured at the same timepoints as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 305719 0
Difference optic nerve sheet diamater (mm) measured by ultrasound.
Timepoint [1] 305719 0
'1-Before induction
2-After intubation
3-Following pneumoperitoneum
4-AFTER PEEP ADMINISTRATION (PRIMARY ENDPOINT)
5-After desuflation
6-Following extubation
Secondary outcome [1] 346235 0
Mean arterial blood pressure measured by digital blood pressure cuff.
Timepoint [1] 346235 0
1-Before induction
2-After intubation
3-Following pneumoperitoneum
4-After PEEP administration
5-After desuflation
6-Following extubation
Secondary outcome [2] 346236 0
Heart rate is measured by ECG
Timepoint [2] 346236 0
1-Before induction
2-After intubation
3-Following pneumoperitoneum
4-After PEEP administration
5-After desuflation
6-Following extubation
Secondary outcome [3] 346401 0
Peak airway pressure recorded from Dräger 'Primus® Infinity® anesthesia machine' ventilator data.
Timepoint [3] 346401 0
1-Before induction
2-After intubation
3-Following pneumoperitoneum
4-After PEEP administration
5-After desuflation
6-Following extubation
Secondary outcome [4] 346466 0
Pulmonary compliance recorded from Dräger 'Primus® Infinity® anesthesia machine' ventilator data.
Timepoint [4] 346466 0
1-Before induction
2-After intubation
3-Following pneumoperitoneum
4-After PEEP administration
5-After desuflation
6-Following extubation

Eligibility
Key inclusion criteria
ASA I-II who were scheduled to undergo laparascopic cholecystectomy.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of acute/chronic Eye disease, Hypertension,Pulmonary disease,Obesity

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/05/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 10363 0
Turkey
State/province [1] 10363 0

Funding & Sponsors
Funding source category [1] 299107 0
Hospital
Name [1] 299107 0
Diskapi Yildirim Beyazit Education and Research Hospital
Country [1] 299107 0
Turkey
Primary sponsor type
Hospital
Name
Diskapi Yildirim Beyazit Education and Research Hospital
Address
Diskapi Yildirim Beyazit Education and Research Hospital
Ziraat Mahallesi, Sehit Ömer Halisdemir Cad. No: 20 Diskapi - Altindag/Ankara
06550
Country
Turkey
Secondary sponsor category [1] 298680 0
None
Name [1] 298680 0
Address [1] 298680 0
Country [1] 298680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300039 0
Ethics committee address [1] 300039 0
Ethics committee country [1] 300039 0
Date submitted for ethics approval [1] 300039 0
Approval date [1] 300039 0
15/05/2017
Ethics approval number [1] 300039 0

Summary
Brief summary
Laparascopic surgical interventions are gaining popularity, but the induction of pneumoperitoneum has been seen alterations in the respiratory mechanics.. These alterations are known to result in a reduction in FRC, VC, an increase in PaCO2, hypoxemia, ventilation / perfusion incompatibility. This issue has revealed the positive effects of administration of positive end expiratory pressure (PEEP) on elastance and resistance in the respiratory system. However, there are publications showing that PEEP application enhances ICP. Pneumoperitoneum also increase in ICP at any given time.
The optic nerve sheath continues with the duramater, and a change in the CSF pressure at the subarachnoid location affects the diameter of the optic nerve sheath.
In this study, we aimed to control 10 cmH2O PEEP in ICP change in 15 mm Hg pneumoperitoneum patients by the change of the optic nerve sheath diameter (Optic nevre sheet diamaetr is measured by ultrasound).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82354 0
A/Prof Reyhan Polat
Address 82354 0
Diskapi Yildirim Beyazit Education and Research Hospital
Ziraat Mahallesi, Sehit Ömer Halisdemir Cad. No: 20 Diskapi - Altindag/Ankara
06550
Country 82354 0
Turkey
Phone 82354 0
+905326734310
Fax 82354 0
Email 82354 0
[email protected]
Contact person for public queries
Name 82355 0
Dr Seher Yanatma
Address 82355 0
Diskapi Yildirim Beyazit Education and Research Hospital
Sehit Ömer Halis Demir Street
Diskapi/Ankara
Country 82355 0
Turkey
Phone 82355 0
+905395672613
Fax 82355 0
Email 82355 0
[email protected]
Contact person for scientific queries
Name 82356 0
A/Prof Murat Sayin
Address 82356 0
Diskapi Yildirim Beyazit Education and Research Hospital
Sehit Ömer Halis Demir Street
Diskapi/Ankara
Country 82356 0
Turkey
Phone 82356 0
+905326147862
Fax 82356 0
Email 82356 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effects of positive end-expiratory pressure (PEEP) application on optic nerve sheath diameter in patients undergoing laparoscopic cholecystectomy: a randomized trial.2023https://dx.doi.org/10.1016/j.bjane.2021.12.006
N.B. These documents automatically identified may not have been verified by the study sponsor.