Clinical trial · Observational
Tidal Volume Challenge and Reliability of Plethysmography Variability Index
Effect of Tidal Volume Challenge on Reliability of Plethysmography Variability Index in Hepatobiliary and Pancreatic Surgeries.
NCT03546179CI-TRIAL-00045810completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to investigate whether a temporary increase in tidal volume can predict fluid responsiveness in patients receiving a low tidal volume ventilation in hepatobiliary and pancreatic surgeries. The hypothesis of this study is that a temporary increase in tidal volume from 6 to 8 ml/kg would improve the predictability of PVI in patients receiving low tidal volume ventilation in surgical procedures with large fluid shift as hepatobiliary and pancreatic procedures.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tidal volume challenge test | Other | — | UNRESOLVED |
| Volume loading | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- detection of best cut-off value of ΔPVI6-8 by using tidal volume challenge.
- timeFrame
- 2 minutes after performing a "tidal volume challenge"
- description
- By Youden index \[sensitivity + (specificity - 1)\]
Secondary outcomes (35)
- measure
- Detection of sensitivity of PVI6 measured by masimo radical 7 equipment..
- timeFrame
- 2 minutes before tidal volume challenge when tidal volume of patient is 6ml/kg
- description
- By areas under the receiver operating characteristics (ROC) curves
- measure
- Detection of specificity of PVI6 measured by masimo radical 7 equipment..
- timeFrame
- 1 minute before tidal volume challenge when tidal volume of patient is 6ml/kg
- description
- By areas under the receiver operating characteristics (ROC) curves
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years undergoing hepatic, pancreatic or biliary tumor resection Exclusion Criteria: * Preoperative cardiac arrhythmias * Peripheral vascular disease * Low left ventricular function (ejection fraction \< 40%) * Significant valvular heart disease * Intra-cardiac shunts * Pulmonary hypertension * Fulminant hepatic failure.
References
Publications (7)
- RESULTTympa A, Theodoraki K, Tsaroucha A, Arkadopoulos N, Vassiliou I, Smyrniotis V. Anesthetic Considerations in Hepatectomies under Hepatic Vascular Control. HPB Surg. 2012;2012:720754. doi: 10.1155/2012/720754. Epub 2012 May 28. PMID 22690040
- RESULTNavarro LH, Bloomstone JA, Auler JO Jr, Cannesson M, Rocca GD, Gan TJ, Kinsky M, Magder S, Miller TE, Mythen M, Perel A, Reuter DA, Pinsky MR, Kramer GC. Perioperative fluid therapy: a statement from the international Fluid Optimization Group. Perioper Med (Lond). 2015 Apr 10;4:3. doi: 10.1186/s13741-015-0014-z. eCollection 2015. PMID 25897397
- RESULTJoshi GP. Intraoperative fluid restriction improves outcome after major elective gastrointestinal surgery. Anesth Analg. 2005 Aug;101(2):601-605. doi: 10.1213/01.ANE.0000159171.26521.31. PMID 16037184
- RESULTSmyrniotis V, Kostopanagiotou G, Theodoraki K, Tsantoulas D, Contis JC. The role of central venous pressure and type of vascular control in blood loss during major liver resections. Am J Surg. 2004 Mar;187(3):398-402. doi: 10.1016/j.amjsurg.2003.12.001. PMID 15006570
- RESULTMichard F, Teboul JL. Using heart-lung interactions to assess fluid responsiveness during mechanical ventilation. Crit Care. 2000;4(5):282-9. doi: 10.1186/cc710. Epub 2000 Sep 1. PMID 11094507
- RESULTMichard F, Schmidt U. Prediction of fluid responsiveness: searching for the Holy Grail. J Appl Physiol (1985). 2004 Aug;97(2):790-1; author reply 791. doi: 10.1152/japplphysiol.00021.2004. No abstract available. PMID 15247205
- RESULTMyatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.