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

NCT04939129 | Unknown

• 1 other identifier: E2-21-468
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pleth Variability Index; Lung Recruitment Maneuver; Fluid Responsiveness

Keywords

pleth variability index; lung recruitment maneuver; fluid responsiveness

Outcome Measures

Primary Outcomes (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.

  first 30 minutes of general anesthesia

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 27922547 BACKGROUND

• 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.

  PMID: 27428237 BACKGROUND

• 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.

  PMID: 21965349 RESULT

• 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.

  PMID: 24557584 RESULT

Study Officials

• Oya Kılcı, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oya Kılcı, MD

CONTACT

+905056919292; oyakilci@gmail.com

Kübra Kaya Güney, MD

CONTACT

+905535224797; kkguney@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: June 15, 2021
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-06

Locations

TU (1)