Minimal Flow Application in One Lung Ventilation

NCT ID: NCT04376307

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-05

Study Completion Date

2020-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Interest in low fresh gas flow anesthesia has increased in recent years. The high standard of anesthesia machines, the presence of monitors that continuously and thoroughly analyze the anesthetic gas composition, and the increased knowledge of the pharmacodynamics and pharmacokinetics of inhalation anesthetics greatly facilitated the safe administration of low-flow anesthesia.Low-flow anesthesia can be mentioned for most patients if modern re-breathing systems are used but only if the fresh gas flow rate is reduced below 2 lt / min. In 1974, Virtue was defined as a technique called minimal flow, in which the fresh gas flow was not exceeded 0.5 lt / min. Although there are too many applications for low current in the literature, there is little literature for use in one lung.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventilator Lung Anesthesia; Functional

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospectice randomized
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

minimal flow anesthesia

the patiennts who have thoracic sugery with one lung ventilaiton

Group Type EXPERIMENTAL

minimal flow anesthesia

Intervention Type PROCEDURE

Investigators will use minimal flow anesthesia (0,5 lt/min) during surgery with one lung ventilation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

minimal flow anesthesia

Investigators will use minimal flow anesthesia (0,5 lt/min) during surgery with one lung ventilation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA 1-3 Patients
* Single lung ventilation during the operation
* Age\>18

Exclusion Criteria

Age\<18

* ASA 4
* pregnancy
* COPD patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fatih Dogu Geyik

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Health Sciences Kartal Dr. Lutfi Kirdar Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fatih Dogu Geyik, MD

Role: primary

+905055671264

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14530937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11437874 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020/514/172/15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Minimal Flow Anesthesia and Infection Risk
NCT07092046 ACTIVE_NOT_RECRUITING NA
Low-Flow Anesthesia and Open-Heart Surgery
NCT07040735 NOT_YET_RECRUITING