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Pleth Variability IndexNCT04939129

Evaluation of Fluid Responsiveness With Pulse Variation Index and Systolic Blood Pressure Changes After Lung Recruitment Maneuver

An observational study of Pleth Variability Index and Lung Recruitment Maneuver, run by Ankara City Hospital Bilkent 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Evaluation of Fluid Responsiveness With Pulse Variation Index and Systolic Blood Pressure Changes After Lung Recruitment Maneuver Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
The research is terminated by calculating the percentage of PVI changes with SAB formed by LRM after fluid challenge.
Type of treatment
Injection or infusion
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jun 2021to 31 Dec 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patient who will undergo elective open abdominal surgery under general anesthesia in our hospital

Who may be able to join

  • ASA physical status 1 to 3 patients, over 18 years of age who will undergo elective open abdominal surgery under general anesthesia

Who cannot join

  • being over 75 years old, pregnant, who are contraindicated to use anesthetic drugs, BMI <18 and BMI> 40, who used inotropes or vasopressor drugs before or during the operation, with preoperative lung disease, with left ventricular ejection fraction less than 30%, with suspected right ventricular dysfunction (due to chronic obstructive pulmonary disease (COPD) or obstructive sleep apnea syndrome (OSAS)), with moderate to severe valvular disease, with hemodynamic instability in the perioperative period, with severe peripheral vascular occlusion, with liver failure, with renal insufficiency, with intracranial hypertension and with pulmonary hypertension.

Trial locations and contacts

1 site in 1 country.

Oya Kılcı, MD contact

+905056919292

oyakilci@gmail.com

Kübra Kaya Güney, MD contact

+905535224797

kkguney@outlook.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara City Hospital

    Ankara

    Oya Kılcı, MD, +905056919292, oyakilci@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Relationship Between The Change in Systolic Blood Pressure and The Pleth Variability Index (PVI) After The Lung Recruitment Maneuver (LRM) to Evaluate Fluid Responsiveness in Open Abdominal Surgeries

Evaluation of Fluid Responsiveness With Pulse Variation Index and Systolic Blood Pressure Changes After Lung Recruitment Maneuver

Read the detailed description

After obtaining ethics committee approval, at least 84 patients who will undergo elective open abdominal surgery under general anesthesia in the operating room of the Ministry of Health Ankara City Hospital will be included in the study. The study is a single center, prospective, observational study.

Weight, height, age, gender, BMI (body mass index), ASA information of the patients will be recorded. Induction and anesthesia management will be applied in accordance with the standard working order of the anesthesia clinic. After the patient is taken to the operating table, non-invasive arterial blood pressure monitoring (noninvasive), 5-lead ECG and pulse oximetry, in addition to standard hemodynamic monitoring, Bispectral Index (BIS), temperature and Massimo ® pulse oximeter (Masimo Corp., Irvine, CA, USA). ) will be monitored. General anesthesia induction will be performed with 0.02 mg / kg midazolam, 1mg / kg lidocaine, 1mcg / kg fentanyl and 2mg / kg propofol after preoxygenation in accordance with the routine practice of the anesthesia clinic, and endotracheal intubation will be performed with a suitable tube for the patient to be provided with 0.6mg / kg rocuronium. BIS target value range will be determined as 40-60, and anesthesia maintenance will be provided by modifying the volatile anesthetic concentration and remifentanil infusion dose (0.1-1 mcg / kg / min) in accordance with hemodynamic values. Ventilation mode and ventilation parameters; tidal volume (6-8 ml / kg according to ideal body weight), respiratory rate (12-16) and end-tidal CO2 values in the range of 30-40 mmhg, inspiratory / expiratory ratio 1: 2, positive end expiratory pressure (PEEP) 5 cm H2O and FiO2: will be set as 50%. After the Allen test to be performed preoperatively, radial artery catheterization and invasive blood pressure monitoring of the non-dominant hand, a 7 fr three lumen central catheter will be placed into the right internal jugular vein with ultrasound (USG) and central venous pressure (CVP) monitoring will be performed. These applications are routinely performed in patients scheduled for open abdominal surgery in our clinic. Preferably 16G or 18G , 2 peripheral venous lines will be placed and fluid will not be given before fluid replacement. Measurements will begin after the patient preparation is complete, after a hemodynamically stable period (defined as the period in which the mean arterial blood pressure (MAP) change is <10% within 5 minutes), in the supine position, and when the patient is confirmed by a second observer that there is no spontaneous breathing effort. Hemodynamic parameters; heart rate (HR) (beats / minute), central venous pressure (CVP) (mmHg), systolic arterial blood pressure (SAP) (mmHg), diastolic arterial blood pressure (DAP) (mmHg), mean arterial blood pressure (MAP) ) (mmHg), peripheral oxygen saturation (SpO2), PVI and BIS baseline values (baseline 1) will be recorded. The LRM will be automatically adjusted in the mechanical ventilator to be at 30 cm H2O for 30 seconds, and the test will begin, all hemodynamic parameters, especially SAB and PVI, where the maximum change at the end of 30 seconds, will be recorded (after LRM), and the differences initial baseline values will be calculated and recorded as percentages. After the recording of the second values, the crystalloid infusion at 10 ml / kg will be made to the patient through the peripheral venous line within 15 minutes, 10 minutes after the end of the infusion, new baseline values will be taken before the test (baseline 2). After fluid replacement, LRM will be repeated in the same way. The values after LRM (Fluid Challenge-FC) will be recorded and differences between basal 2 values will be calculated and recorded as percentages. Primary measurement parameters are determined as PVI and SAB, and secondary measurement parameters are HR, DAB, OAB, SpO2, CVP and BIS. The research is terminated by calculating the percentage of PVI changes with SAB formed by LRM after fluid challenge.

Being tested
The research is terminated by calculating the percentage of PVI changes with SAB formed by LRM after fluid challenge.
Keywords
pleth variability index, lung recruitment maneuver, fluid responsiveness

What participants receive

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

  • The research is terminated by calculating the percentage of PVI changes with SAB formed by LRM after fluid challenge.Diagnostic test

    Measurements will begin after a hemodynamically stable period in the supine position.Heart rate, central venous pressure, systolic, diastolic and mean arterial pressure, peripheral oxygen saturation, PVI and BIS baseline values (baseline 1) will be recorded.LRM will be automatically adjusted in the mechanical ventilator(30 cm H2O/30 seconds) and all hemodynamic parameters where the maximum change at the end of 30 seconds, will be recorded(after LRM), and the differences initial baseline values will be calculated and recorded as percentages.After the recording of the second values, the crystalloid infusion at 10ml/kg will be made to the patient through the peripheral venous line within 15minutes, new baseline values will be taken before the test(baseline 2).After fluid replacement, LRM will be repeated in the same way. The values after LRM(Fluid Challenge-FC) will be recorded and differences between basal 2 values will be calculated and recorded as percentages.

What is being measured

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

  1. correlation between systolic blood pressure change after LRM and PVI in patients who will undergo elective open abdominal surgery under general anesthesia

    In this study, the presence of a correlation between systolic blood pressure change after LRM and PVI in patients who will undergo elective open abdominal surgery under general anesthesia, the systolic pressure change in LRM is a non-invasive test that can be used to predict fluid responsiveness. We aim to reduce the invasive procedures required for the measurement of cardiac output used in the evaluation and to develop an alternative method to the use of expensive and not always accessible devices required for measurements.

    Measured: first 30 minutes of general anesthesia

Timeline

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

  1. First posted25 Jun 2021
  2. Study start15 Jun 2021
  3. Primary completion1 Jul 2021
  4. Study completion31 Dec 2021 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939129
Sponsor's protocol ID
E2-21-468
Status last verified
Jun 2021
First submitted
17 Jun 2021
Last updated
3 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Biais M, Lanchon R, Sesay M, Le Gall L, Pereira B, Futier E, Nouette-Gaulain K. Changes in Stroke Volume Induced by Lung Recruitment Maneuver Predict Fluid Responsiveness in Mechanically Ventilated Patients in the Operating Room. Anesthesiology. 2017 Feb;126(2):260-267. doi: 10.1097/ALN.0000000000001459.

    PubMed 27922547
  • De Broca B, Garnier J, Fischer MO, Archange T, Marc J, Abou-Arab O, Dupont H, Lorne E, Guinot PG. Stroke volume changes induced by a recruitment maneuver predict fluid responsiveness in patients with protective ventilation in the operating theater. Medicine (Baltimore). 2016 Jul;95(28):e4259. doi: 10.1097/MD.0000000000004259.

    PubMed 27428237
  • Hood JA, Wilson RJ. Pleth variability index to predict fluid responsiveness in colorectal surgery. Anesth Analg. 2011 Nov;113(5):1058-63. doi: 10.1213/ANE.0b013e31822c10cd. Epub 2011 Sep 30.

    PubMed 21965349
  • Yu Y, Dong J, Xu Z, Shen H, Zheng J. Pleth variability index-directed fluid management in abdominal surgery under combined general and epidural anesthesia. J Clin Monit Comput. 2015 Feb;29(1):47-52. doi: 10.1007/s10877-014-9567-5. Epub 2014 Feb 21.

    PubMed 24557584

Questions about this trial

What is this clinical trial studying?

An observational study of Pleth Variability Index and Lung Recruitment Maneuver, run by Ankara City Hospital Bilkent 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 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: status not confirmed, as of the sponsor's last update on 3 Aug 2021. 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?

Contact Oya Kılcı, MD (+905056919292, oyakilci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

correlation between systolic blood pressure change after LRM and PVI in patients who will undergo elective open abdominal surgery under general anesthesia (time frame: first 30 minutes of general anesthesia). 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 NCT04939129, which also lists 4 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 3 Aug 2021.

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