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Ventilator LungNCT04376307

Minimal Flow Application in One Lung Ventilation

A study testing minimal flow anesthesia in people with Ventilator Lung and Anesthesia; Functional, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Ventilator Lung, Anesthesia; Functional
What is being tested?
minimal flow anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 May 2020to 1 Sep 2020
Phase
Interventional
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Age<18
  • ASA 4
  • pregnancy
  • COPD patients

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting

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

    Istanbul, 34860

    Fatih Dogu Geyik, MD, +905055671264, dogugeyik@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Minimal Flow Anesthesia on Hemodynamic Parameters, Compilation and Gas Consumption in Single Lung Ventilation

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.

Read the 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.

Being tested
minimal flow anesthesia
Keywords
one lung ventilation, low flow anesthesia, gas consumption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • minimal flow anesthesiaProcedure or surgery

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

Study groups in NCT04376307
Study groupRoleWhat they receive
minimal flow anesthesiaExperimentalthe patiennts who have thoracic sugery with one lung ventilaiton
Receives: Procedure: minimal flow anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age

    Years

    Measured: during surgery

  2. Gender

    Male/Female

    Measured: during surgery

  3. ASA :

    I, II, III, IV

    Measured: during surgery

  4. Height:

    centimeter

    Measured: during surgery

  5. Weight

    kilogram

    Measured: during surgery

  6. BMI:

    kg/m2

    Measured: during surgery

  7. Side of surgery

    left /right

    Measured: during surgery

  8. Side of double lumen tube

    left/right

    Measured: during surgery

  9. Desfluran consumption

    ml

    Measured: during surgery

  10. Heart Rate

    beats /minute

    Measured: during surgery

  11. SpO2

    percent

    Measured: during surgery

  12. Systolic Blood Pressure

    mmHg/min

    Measured: during surgery

  13. Diastolic Blood Pressure

    mmHg/min

    Measured: during surgery

  14. Respiratory Rate

    frequency/ min

    Measured: during surgery

  15. Intubation tube size

    french

    Measured: during surgery

  16. duration of anesthesia

    minutes

    Measured: during surgery

  17. Duration of single lung ventilation

    minutes

    Measured: during surgery

  18. Operation time

    minutes

    Measured: during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2020
  2. Study start5 May 2020
  3. Primary completion31 Aug 2020 (estimated)
  4. Study completion1 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
prospectice randomized
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04376307
Sponsor's protocol ID
2020/514/172/15
Status last verified
May 2020
First submitted
24 Apr 2020
Last updated
6 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 14530937

  • 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.

    PubMed 11437874

Questions about this trial

What is this clinical trial studying?

A study testing minimal flow anesthesia in people with Ventilator Lung and Anesthesia; Functional, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age (time frame: during surgery). The study lists 18 primary outcomes in all. 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 NCT04376307, which also lists 2 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 6 May 2020.

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