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).
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
- Conditions the study is for
- Pleth Variability Index, Lung Recruitment Maneuver, Fluid Responsiveness
- 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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara
Oya Kılcı, MD, +905056919292, oyakilci@gmail.com
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.
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.
- First posted25 Jun 2021
- Study start15 Jun 2021
- Primary completion1 Jul 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pleth Variability IndexStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oya Kılcı, MD, Principal investigator, Ankara City Hospital Bilkent
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 27922547De 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 27428237Hood 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 21965349Yu 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04939129
- Acronym / sponsor ID
- E2-21-468
- Keywords
- pleth variability index, lung recruitment maneuver, fluid responsiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of Fluid Responsiveness With Pulse Variation Index and Systolic Blood Pressure Changes After Lung Recruitment Maneuver
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient who will undergo elective open abdominal surgery under general anesthesia in our hospital
Key inclusion criteria (1 listed)
- ASA physical status 1 to 3 patients, over 18 years of age who will undergo elective open abdominal surgery under general anesthesia
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The research is terminated by calculating the percentage of PVI changes with SAB formed by LRM after fluid challenge.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. | Diagnostic test | – |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 27922547Biais 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.
- Background: PubMed 27428237De 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.
- Results publication: PubMed 21965349Hood 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.
- Results publication: PubMed 24557584Yu 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pleth Variability Index
Not yet recruiting
Effect of Prewarming Duration on Blood Flow After Colon Resection Surgery
Perioperative Hypothermia
Not yet recruiting
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation
RecruitingObservational study
Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery
Craniosynostosis
RecruitingObservational study
Incidence and Risk Factors of Post-Induction Hypotension in Geriatric Cancer Patients
Post-induction Hypotension (PIH), Geriatric Patient
RecruitingObservational study
Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis
Hypotension and Shock, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oya Kılcı, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
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.