- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04376307
Minimal Flow Application in One Lung Ventilation
The Effects of Minimal Flow Anesthesia on Hemodynamic Parameters, Compilation and Gas Consumption in Single Lung Ventilation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our research is planned prospectively. During the preoperative examination, patients will be informed about the study and their written consent will be obtained. On the morning of the operation, anesthesia gas monitor calibration and leak test will be started with automatic tests of the anesthesia device (Drager-Perseus A500).The leak test for the ventilator and breathing circuit for the patient will be repeated in all operations. The carbon dioxide trap will be evaluated in terms of its dryness and color and will be replaced at appropriate times. The patients who were taken to the operation table were venously opened with a 20-gauge cannula from the back of the hand, and perfusion of 10 ml / kg / h 0.9% sodium chloride was started. ECG, SPO2, NIBP monitoring (Siemens SC-7700), starting before anesthesia (basal), after induction, after intubation 1.min and 5., 10., 15., 20., 25., 30., 40 ., 50th, 60th, 75th, 90th, 105th, 120th minutes and preoperative arterial blood gas (AKG) will be taken.1μg / kg fentanyl (Fentanyl Citrate, Abbott Lab. North Chicago, USA), 5-7 mg / kg thiopental (Pental) for anesthesia induction after preoxygenation in 100% O2 and fresh gas flow 4L / min with spontaneous breathing for 3 minutes with mask sodium, IE Ulagay, Istanbul, Turkey) and 0.1 mg / kg vecuronium (Norcuro, Organon, Oss. the Netherlands) was administered iv. When muscle relaxation was observed, orotracheal intubation was performed and the patient (Dräger Perseus) was adjusted with an anesthesia device to have a tidal volume of 7-10 ml / kg, respiratory frequency 12 / min, and the ratio of I: E 1: 2. The tube was placed by selective intubation with the help of fiberoptic bronchoscopy. MAC values will be kept between 4-6%. Alarm limits FiO2 30% lower limit, desflurane 10% vol upper limit, EtCO2 45mmhg upper limit Paw 5cmh20 six lower limit, 30cmh2o upper limit set. co2 absorbent, as sodalime (Sorbo-lime, Berk, Turkey) were used.
Arterial Blood Gas (ABG) analysis will be performed at zero and then half hour intervals of single lung ventilation. Special attention will be paid not to open the system. Muscle relaxant antagonism will be achieved in all patients with 0.01mg / kg of atropine and 0.03mg / kg of neostigmine. At the end of the operation, the recovery period characteristics of all patients at the 1st, 5th, and 10th minutes before and after extubation were evaluated with Aldrete Kraulik's post-anesthesia evaluation system. Gas consumption amounts will be monitored on the monitor and recorded.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34860
- Recruiting
- University of Health Sciences Kartal Dr. Lutfi Kirdar Education and Research Hospital
-
Contact:
- Fatih Dogu Geyik, MD
- Phone Number: +905055671264
- Email: dogugeyik@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA 1-3 Patients
- Single lung ventilation during the operation
- Age>18
Exclusion Criteria:
Age<18
- ASA 4
- pregnancy
- COPD patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: minimal flow anesthesia
the patiennts who have thoracic sugery with one lung ventilaiton
|
Investigators will use minimal flow anesthesia (0,5 lt/min) during surgery with one lung ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operation time
Time Frame: during surgery
|
minutes
|
during surgery
|
|
Age
Time Frame: during surgery
|
Years
|
during surgery
|
|
Gender
Time Frame: during surgery
|
Male/Female
|
during surgery
|
|
ASA :
Time Frame: during surgery
|
I, II, III, IV
|
during surgery
|
|
Height:
Time Frame: during surgery
|
centimeter
|
during surgery
|
|
Weight
Time Frame: during surgery
|
kilogram
|
during surgery
|
|
BMI:
Time Frame: during surgery
|
kg/m2
|
during surgery
|
|
Side of surgery
Time Frame: during surgery
|
left /right
|
during surgery
|
|
Side of double lumen tube
Time Frame: during surgery
|
left/right
|
during surgery
|
|
Desfluran consumption
Time Frame: during surgery
|
ml
|
during surgery
|
|
Heart Rate
Time Frame: during surgery
|
beats /minute
|
during surgery
|
|
SpO2
Time Frame: during surgery
|
percent
|
during surgery
|
|
Systolic Blood Pressure
Time Frame: during surgery
|
mmHg/min
|
during surgery
|
|
Diastolic Blood Pressure
Time Frame: during surgery
|
mmHg/min
|
during surgery
|
|
Respiratory Rate
Time Frame: during surgery
|
frequency/ min
|
during surgery
|
|
Intubation tube size
Time Frame: during surgery
|
french
|
during surgery
|
|
duration of anesthesia
Time Frame: during surgery
|
minutes
|
during surgery
|
|
Duration of single lung ventilation
Time Frame: during surgery
|
minutes
|
during surgery
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Baum JA. Low-flow anesthesia: theory, practice, technical preconditions, advantages, and foreign gas accumulation. J Anesth. 1999;13(3):166-74. doi: 10.1007/s005400050050. No abstract available.
- Honemann CW, Hahnenkamp K, Mollhoff T, Baum JA. Minimal-flow anaesthesia with controlled ventilation: comparison between laryngeal mask airway and endotracheal tube. Eur J Anaesthesiol. 2001 Jul;18(7):458-66. doi: 10.1046/j.1365-2346.2001.00868.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/514/172/15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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