Clinical trial NCT05171608: Preoperative Ultrasound-based Protocol for Optimization of Fluid Therapy to Prevent Early Intraoperative Hypotension
Official title: Preoperative Ultrasound-based Protocol for Optimization of Fluid Therapy to Prevent Hypotension Associated to General Anesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Hypotension
Lung Ultrasound
Echocardiography
Perioperative Complication
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled study
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

Elective surgery

* General surgical procedures
* Estimated duration of anesthesia \> 60 minutes
* ASA class 2 or 3

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Rate of hypotension associated to general anesthesia induction
timeFrame: first 10 minutes of anesthesia
Secondary outcomes:
measure: Dose of preoperative fluid therapy (in millilitres)
timeFrame: preoperative time frame on the day of surgery
measure: Dose fluid therapy of the operative day (in millilitres)
timeFrame: 24 hours
measure: lactate level (mmol/l)
timeFrame: 1st postoperative hour
measure: base excess (mmol/l)
timeFrame: 1st postoperative hour
measure: urine output (millilitres/24 h)
timeFrame: 24 hours
measure: lung ultrasound score (LUS)
timeFrame: 24th postoperative hour
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Deparment of Surgery, Transplantation and Gastroenterology
Study officials:
affiliation: Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
name: Sándor Soós, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Szabo 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.
citation: Bijker 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.
citation: Lichtenstein 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.
citation: Zhang 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.