AnesthesiaNCT05171608
Preoperative Ultrasound-based Protocol for Optimization of Fluid Therapy to Prevent Early Intraoperative Hypotension
A study testing Ultrasound-based protocol based fluid therapy in people with Anesthesia and Hypotension, run by Semmelweis University at 1 site in Hungary.
Trial summary
Background: Intraoperative hypotension increases 30-day mortality and the risks of myocardial injury and acute renal failure. Patients with inadequate volume reserve before the induction of anesthesia are highly exposed. The identification of latent hypovolemia is therefore crucial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Hypotension, Lung Ultrasound
- What is being tested?
- Ultrasound-based protocol based fluid therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHungary
- Study dates
- 15 Dec 2021to 31 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery
- General surgical procedures
- Estimated duration of anesthesia > 60 minutes
- ASA class 2 or 3
Who cannot join
- Emergency procedure
- Reoperation, redo procedure
- Patient who is incapable of acting
- Uncontrolled hypotension (<90 mmHg)
- Uncontrolled hypertension (>180 mmHg)
- High risk valvular disease (Aortic Stenosis)
Show all 10Show fewer
- Endocrine hypertension (Conn's syndrome, phaeochromocytoma)
- Sepsis (infection and SOFA≥2 pt)
- Conditions blocking lung ultrasound (pneumothorax without drainage, former pulmonary resection, pleural effusion affecting more than 2 interspaces)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Deparment of Surgery, Transplantation and Gastroenterology
Budapest, 1082
About this study
Official title: Preoperative Ultrasound-based Protocol for Optimization of Fluid Therapy to Prevent Hypotension Associated to General Anesthesia: a Randomized Controlled Trial
Background: Intraoperative hypotension increases 30-day mortality and the risks of myocardial injury and acute renal failure. Patients with inadequate volume reserve before the induction of anesthesia are highly exposed. The identification of latent hypovolemia is therefore crucial. Ultrasonographic measurement of the inferior vena cava collapsibility index (IVCCI) is able to detect volume responsiveness in circulatory shock and growing evidence support the theory that higher IVCCI can predict intraoperative hypotension.
The aim of the present study is to evaluate the potential benefit of an ultrasound-based protocol for preoperative fluid optimization. The investigators will perform a randomized-controlled study involving elective surgical patients. An ultrasound-based protocol (USP) arm and a conventional fluid therapy group (CFT) are to be formed. Ultrasound examinations will be performed twice in both groups: 2 hours and 30 minutes preoperatively. The inferior vena cava and the anterior lung fields will be scanned. In the USP group the participants will receive fluid therapy according to the ultrasonographic findings: high level of IVCCI and absence of signs of pulmonary edema will indicate fluid therapy. In the CFT group the attending anesthesiologist (blinded to the results of ultrasonography) will order fluid therapy on the basis of daily routine and clinical judgement.
The investigators will evaluate the incidence of intraoperative hypotension (primary outcome), postoperative metabolic status and organ functions and the amount of the administered intravenous fluids in both groups.
Read the detailed description
A randomized-controlled study with 80 participants.
The investigators will use computer-generated unpaired random allocation method to an ultrasound-based protocol (USP) group or to the conventional fluid therapy (CFT) group.
Preoperative ultrasound examinations will be performed twice in both groups: 2 hours and 30 minutes preoperatively. The inferior vena cava and the lung fields (so called BLUE - Bedside Lung Ultrasound in Emergency - points: 2nd or 3rd intercostal space anterior, 5th-6th interspace anterior and posterior axillary line position) will be scanned. The collapsibility index (IVCCI) of the IVC is calculated, >40 percent is considered 'high IVCCI'. Lung ultrasound (LUS) is evaluated as indicative for 'lung congestion' if symmetric anterior B-profiles (at least 3 B-lines in anterior lung fields) are detected.
Baseline demographic (age, sex, height, weight) and comorbidity data (history of hypertension, chronic heart failure, coronary or cerebrovascular disease, respiratory illness e.g. COPD, past COVID, diabetes on insulin treatment) together with laboratory data (haemoglobin, creatinine, blood urea) are to be recorded.
A standardized practice of monitoring and induction of general anesthesia will allow for the detection of immediate and early (first 10 minutes of anesthesia) hypotensive events. A follow up for 24 hours is necessary for evaluating the fulfillment of secondary endpoints. A semi-quantitative lung ultrasound after 24 hours will estimate lung aeration.
- Being tested
- Ultrasound-based protocol based fluid therapy
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-based protocol based fluid therapyProcedure or surgery
Protocol of the interventional group according to the ultrasonographic findings:
Ultrasound scan 2 hours before surgery:
IVCCI>40 percent and absence of symmetric anterior 'B-profile' on the lung ultrasound indicate intravenous (IV) fluid therapy: 8 ml/kg of isotonic, balanced crystalloid infusion.
IVCCI≤40 percent AND/OR symmetric anterior 'B-profile' contraindicates further IV fluid therapy.
A 2nd ultrasound scan at 30 minutes before surgery:
IVCCI>40 percent and absence of symmetric anterior 'B-profile' on the lung ultrasound indicate further IV fluid therapy: 5 ml/kg of isotonic, balanced crystalloid infusion.
IVCCI≤40 percent AND/OR symmetric anterior 'B-profile' contraindicates further IV fluid therapy.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-based protocol group (USP) | Experimental | Preoperative intravenous (IV) fluid therapy is order according to the result of the preoperative ultrasound scans of the inferior vena cava and the lungs (2 hours and 30 minutes before surgery) Receives: Procedure: Ultrasound-based protocol based fluid therapy |
| Conventional fluid therapy | No intervention | Preoperative IV fluid therapy (isotonic, balanced crystalloid infusion, if any) is determined by the discretion of the attending anesthesiologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hypotension associated to general anesthesia induction
mean arterial pressure < 65 mmHg AND/OR ≥30 percent of decrease compared to baseline (before induction of anesthesia)
Measured: first 10 minutes of anesthesia
Secondary outcomes (6)
Dose of preoperative fluid therapy (in millilitres)
intravenous fluid therapy before anesthesia induction
Measured: preoperative time frame on the day of surgery
Dose fluid therapy of the operative day (in millilitres)
all intravenous fluid therapy on the day of surgery
Measured: 24 hours
lactate level (mmol/l)
highest lactate level in mmol of an arterial blood sample
Measured: 1st postoperative hour
base excess (mmol/l)
worst base excess level in mmol of an arterial blood sample
Measured: 1st postoperative hour
urine output (millilitres/24 h)
summarized urine output after surgery
Measured: 24 hours
lung ultrasound score (LUS)
Summarized lung ultrasound score of 12 fields of the thorax (0-36 pts)
Measured: 24th postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start15 Dec 2021
- Primary completion29 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcell Szabo, Semmelweis University
- Investigators
- Sándor Soós, PhD, Principal investigator, Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171608
- Sponsor's protocol ID
- PUSPO
- Status last verified
- Sep 2022
- First submitted
- 10 Dec 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szabo M, Bozo A, Darvas K, Horvath A, Ivanyi ZD. Role of inferior vena cava collapsibility index in the prediction of hypotension associated with general anesthesia: an observational study. BMC Anesthesiol. 2019 Aug 7;19(1):139. doi: 10.1186/s12871-019-0809-4.
PubMed 31390983Szabo M, Bozo A, Darvas K, Soos S, Ozse M, Ivanyi ZD. The role of ultrasonographic lung aeration score in the prediction of postoperative pulmonary complications: an observational study. BMC Anesthesiol. 2021 Jan 14;21(1):19. doi: 10.1186/s12871-021-01236-6.
PubMed 33446103Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
PubMed 19934864Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313.
PubMed 26033127Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
PubMed 26771910Szabo M, Pleck AP, Soos SA, Keczer B, Varga B, Szell J. A preoperative ultrasound-based protocol for optimisation of fluid therapy to prevent early intraoperative hypotension: a randomised controlled study. Perioper Med (Lond). 2023 Jun 27;12(1):30. doi: 10.1186/s13741-023-00320-4.
PubMed 37370150
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ultrasound-based Protocol for Optimization of Fluid Therapy to Prevent Hypotension Associated to General Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05171608
- Acronym / sponsor ID
- PUSPO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 29 Dec 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.
Background: Intraoperative hypotension increases 30-day mortality and the risks of myocardial injury and acute renal failure. Patients with inadequate volume reserve before the induction of anesthesia are highly exposed. The identification of latent hypovolemia is therefore crucial. Ultrasonographic measurement of the inferior vena cava collapsibility index (IVCCI) is able to detect volume responsiveness in circulatory shock and growing evidence support the theory that higher IVCCI can predict intraoperative hypotension.
The aim of the present study is to evaluate the potential benefit of an ultrasound-based protocol for preoperative fluid optimization. The investigators will perform a randomized-controlled study involving elective surgical patients. An ultrasound-based protocol (USP) arm and a conventional fluid therapy group (CFT) are to be formed. Ultrasound examinations will be performed twice in both groups: 2 hours and 30 minutes preoperatively. The inferior vena cava and the anterior lung fields will be scanned. In the USP group the participants will receive fluid therapy according to the ultrasonographic findings: high level of IVCCI and absence of signs of pulmonary edema will indicate fluid therapy. In the CFT group the attending anesthesiologist (blinded to the results of ultrasonography) will order fluid therapy on the basis of daily routine and clinical judgement.
The investigators will evaluate the incidence of intraoperative hypotension (primary outcome), postoperative metabolic status and organ functions and the amount of the administered intravenous fluids in both groups.
Detailed description
A randomized-controlled study with 80 participants.
The investigators will use computer-generated unpaired random allocation method to an ultrasound-based protocol (USP) group or to the conventional fluid therapy (CFT) group.
Preoperative ultrasound examinations will be performed twice in both groups: 2 hours and 30 minutes preoperatively. The inferior vena cava and the lung fields (so called BLUE - Bedside Lung Ultrasound in Emergency - points: 2nd or 3rd intercostal space anterior, 5th-6th interspace anterior and posterior axillary line position) will be scanned. The collapsibility index (IVCCI) of the IVC is calculated, >40 percent is considered 'high IVCCI'. Lung ultrasound (LUS) is evaluated as indicative for 'lung congestion' if symmetric anterior B-profiles (at least 3 B-lines in anterior lung fields) are detected.
Baseline demographic (age, sex, height, weight) and comorbidity data (history of hypertension, chronic heart failure, coronary or cerebrovascular disease, respiratory illness e.g. COPD, past COVID, diabetes on insulin treatment) together with laboratory data (haemoglobin, creatinine, blood urea) are to be recorded.
A standardized practice of monitoring and induction of general anesthesia will allow for the detection of immediate and early (first 10 minutes of anesthesia) hypotensive events. A follow up for 24 hours is necessary for evaluating the fulfillment of secondary endpoints. A semi-quantitative lung ultrasound after 24 hours will estimate lung aeration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-based protocol group (USP) | Experimental | Procedure: Ultrasound-based protocol based fluid therapyPreoperative intravenous (IV) fluid therapy is order according to the result of the preoperative ultrasound scans of the inferior vena cava and the lungs (2 hours and 30 minutes before surgery) |
| Conventional fluid therapy | No intervention | –Preoperative IV fluid therapy (isotonic, balanced crystalloid infusion, if any) is determined by the discretion of the attending anesthesiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective surgery
- General surgical procedures
- Estimated duration of anesthesia > 60 minutes
- ASA class 2 or 3
Key exclusion criteria (10 listed)
- Emergency procedure
- Reoperation, redo procedure
- Patient who is incapable of acting
- Uncontrolled hypotension (<90 mmHg)
- Uncontrolled hypertension (>180 mmHg)
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 |
|---|---|---|
| Ultrasound-based protocol based fluid therapyProtocol of the interventional group according to the ultrasonographic findings: Ultrasound scan 2 hours before surgery: IVCCI>40 percent and absence of symmetric anterior 'B-profile' on the lung ultrasound indicate intravenous (IV) fluid therapy: 8 ml/kg of isotonic, balanced crystalloid infusion. IVCCI≤40 percent AND/OR symmetric anterior 'B-profile' contraindicates further IV fluid therapy. A 2nd ultrasound scan at 30 minutes before surgery: IVCCI>40 percent and absence of symmetric anterior 'B-profile' on the lung ultrasound indicate further IV fluid therapy: 5 ml/kg of isotonic, balanced crystalloid infusion. IVCCI≤40 percent AND/OR symmetric anterior 'B-profile' contraindicates further IV fluid therapy. | Procedure or surgery | Ultrasound-based protocol group (USP) |
Primary outcome
Rate of hypotension associated to general anesthesia induction
Time frame: first 10 minutes of anesthesia
mean arterial pressure < 65 mmHg AND/OR ≥30 percent of decrease compared to baseline (before induction of anesthesia)
6 secondary outcomes
Dose of preoperative fluid therapy (in millilitres)
Time frame: preoperative time frame on the day of surgery
Dose fluid therapy of the operative day (in millilitres)
Time frame: 24 hours
lactate level (mmol/l)
Time frame: 1st postoperative hour
base excess (mmol/l)
Time frame: 1st postoperative hour
urine output (millilitres/24 h)
Time frame: 24 hours
lung ultrasound score (LUS)
Time frame: 24th postoperative hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Background: PubMed 31390983Szabo M, Bozo A, Darvas K, Horvath A, Ivanyi ZD. Role of inferior vena cava collapsibility index in the prediction of hypotension associated with general anesthesia: an observational study. BMC Anesthesiol. 2019 Aug 7;19(1):139. doi: 10.1186/s12871-019-0809-4.
- Background: PubMed 33446103Szabo M, Bozo A, Darvas K, Soos S, Ozse M, Ivanyi ZD. The role of ultrasonographic lung aeration score in the prediction of postoperative pulmonary complications: an observational study. BMC Anesthesiol. 2021 Jan 14;21(1):19. doi: 10.1186/s12871-021-01236-6.
- Background: PubMed 19934864Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
- Background: PubMed 26033127Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313.
- Background: PubMed 26771910Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
- Derived from this study: PubMed 37370150Szabo M, Pleck AP, Soos SA, Keczer B, Varga B, Szell J. A preoperative ultrasound-based protocol for optimisation of fluid therapy to prevent early intraoperative hypotension: a randomised controlled study. Perioper Med (Lond). 2023 Jun 27;12(1):30. doi: 10.1186/s13741-023-00320-4.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Sándor Soós, PhD principal investigator
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-based protocol based fluid therapy in people with Anesthesia and Hypotension, run by Semmelweis University at 1 site in Hungary.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 7 Sep 2022. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hypotension associated to general anesthesia induction (time frame: first 10 minutes of 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 NCT05171608, which also lists 6 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 7 Sep 2022.