Assessments of Dynamic Variables of Fluid Responsiveness to Predict Desufflation-induced Hypotension in Urologic Patients Undergoing Laparoscopic Surgery

NCT03967119 | Unknown

• 1 other identifier: 4-2019-0203
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic surgery can induce hemodynamic pertubations. Pneumoperitoneum, inevitable in laparoscopic surgery, induces increase in intra-abdominal pressure, which can decrease cardiac output. Simultaneously, pneumoperitoneum can stimulate sympathetic system and increase vascular resistance/arterial blood pressure. Patients undergoing laparoscopic surgery may show a normal range of blood pressure during pneumoperitoneum even when the patients are in hypovolemia, and desufflation at the end of main surgical procedure can cause an abrupt hypotension revealing hypovolemia. Therefore, appropriate fluid management is essential for preventing desufflation-induced hypotension in laparoscopic surgery. Recently, dynamic variables are used to predict and guide fluid therapy during controlled ventilation. these variables arise from heart-lung interactions during positive ventilation, which influence left ventricular stroke volume. Several dynamic variables are derived from variations in left ventricular stroke volume (stroke volume variation, SVV), for example pulse pressure variation (PPV), and variations in pulse oximetry plethysmography waveform amplitude (PWV), which have all been shown to predict fluid responsiveness in different clinical and experimental settings. However, there are few evidences regarding which type of dynamic variables can predict desufflation-induced hypotension in laparoscopic surgery. Therefore, this study was designed to assess the predictive abilities of three different type of dynamic variables including PPV, SVV, and PWV for desufflation-induced hypotension in patients undergoing laparoscopic surgery.

Conditions

Deflation Induced Hypotension; Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• AUC for dynamic variables to predict deflation-induced hypotension

  To test the abilities of dynamic variables to predict curves (AUC) are calculated in each type of dynamic variables at each tidal volume level (6 or 12 ml/kg).

  Dynamic variables at T3 (10 minutes before desufflation)

• AUC for dynamic variables to predict deflation-induced hypotension

  To test the abilities of dynamic variables to predict desufflation-induced hypotension, the areas under receiver-operating characteristic curves (AUC) are calculated in each type of dynamic variables at each tidal volume level (6 or 12 ml/kg).

  Hypotension occurence at T4 (immediately after desufflation)

Secondary Outcomes (2)

• Cut-off value for dynamic variables to predict deflation-induced hypotension

  Dynamic variables at T3 (10 minutes before desufflation)

• Cut-off value for dynamic variables to predict deflation-induced hypotension

  Hypotension occurence at T4 (immediately after desufflation)

Study Arms (1)

Laparoscopic surgery

The following parameters are assessed and recorded at the following time points in all participants. The parameters assessed: mean arterial pressure, heart rate, pulse oxygen saturation, SVV, PPV, PWV, peak inspiratory pressure, plateau pressure, positive end-expiratory pressure, respiratory rate (all dynamic variables are assessed at two levels of tidal volume- 6 ml/kg and 12 ml/kg). The time points: T0, before anesthetic induction; T1, immediately after anesthetic induction; T2, immediately after pneumoperitoneum; T3, 10 min before desufflation; T4, immediately after desufflation. The desufflation-induced hypotension is defined as more than 20 % decrease in MAP at T4 from MAP at T3.

Device: Patient monitoring

Interventions

Patient monitoring DEVICE

Arterial blood pressure, pulse oxygen saturation, and cardiac output/stroke volume are monitored with invasive arterial catheter, pulse oxymetry, and esophageal doppler in all participants. Some dynamic variables including SVV and PPV are automatically calculated in each monitor. PWV is manually calculated in a printed plethysmographic waveform. Plethysmographic waveform amplitude (PW) is measured on a beat-to-beat basis as the vertical distance between peaks and preceding valley troughs in the waveform. The maximum PW (PWmax) and minimum PW (PWmin) are determined manually over the same respiratory cycle, and PWV is calculated. PWV=(PWmax-PWmin)/\[(PWmax+PWmin)/2\].

Laparoscopic surgery

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic surgery for urologic procedures

You may qualify if:

• \. laparoscopic nephrectomy
• \. laparoscopic nephro-ureterectomy
• \. laparoscopic adrenalectomy

You may not qualify if:

• \. ASA physical status 3 and greater
• \. preoperative arrhythmia
• \. moderate to severe valvular disease
• \. ventricular ejection fraction \< 40%
• \. inotrope use
• \. moderate to severe chronic obstructive pulmonary disease
• \. moderate to severe renal or hepatic disease

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Interventions

Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Jaehoon Lee

CONTACT

+82-2-2228-2420; neogens@yuhs.ac

Study Design

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

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: May 30, 2019
• Study Start: April 25, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

KR (1)