Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy

NCT02653469 | Completed

• 1 other identifier: SMC 2015-06-015
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. Generally, patients are considered to be fluid-responsive when the PPV value larger than 11-13%. However, several previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%), the investigators would evaluate the augmented PPV using augmented ventilation.

Conditions

Gynecologic Neoplasms; Abdominal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness

  Augmented ventilation (12ml/kg) will be performed when the participant's PPV is within grey zone (9-13%). PPV value will be collected automatically by Intelivue philips patient monitor. Percentage changes in stroke volume index by EV1000 according to fluid loading were used as principal indicators of fluid responsiveness. Patients were classified as responders or non-responders when increases in SVI were ≥ 10% or \<10% after volume loading (crystalloid iv 6ml/kg). To test the abilities of augmented PPV to predict fluid responsiveness, areas under the receiver operating characteristics (ROC) curves of the responders \[area under the curve (AUC) = 0.5: no better than chance, no prediction possible; AUC = 1.0: best possible prediction\] will be calculated.

  within 2 min from augmented ventilation

Secondary Outcomes (1)

• Conventional baseline PPV to predict fluid responsiveness

  when patients PPV in grey zone, before augmented ventilation

Study Arms (1)

Augmented ventilation with fluid loading

This is an observational study and as a diagnostic intervention, subjects in the study would receive mechanical ventilation with augmented tidal volume of 12ml/kg for 2min. Augmented ventilation is performed when the patient's PPV is within grey zone (9-13%). The investigators perform this procedure to every patients and do not assigh this intervention to the subjects of the study. Then, 6ml/kg of ballanced crystalloid loading will be infused to every patient.

Other: Augmented ventilation; Other: Fluid loading

Interventions

Augmented ventilation OTHER

When the patient's PPV is within grey zone, patient's tidal volume is maintained with augmented tidal volume of 12 ml/kg (from normal ventilation of 8ml/kg) for 2min duration.

Augmented ventilation with fluid loading

Fluid loading OTHER

We record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid

Also known as: Balanced crystalloid infusion

Augmented ventilation with fluid loading

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective open laparotomy surgery.

You may qualify if:

• Adult patients undergoing elective open laparotomy surgery.

You may not qualify if:

• Irregular heart beats,
• cardiac arrhythmia,
• moderate or severe valvular heart disease,
• preoperative left ventriular ejection fraction less than 40%,
• moderate t severe obstructive pulmonary disease,
• preoperative need of inotropics infusion,
• preoperative serum Cr \> 1.3ml/dl,
• moderate to severe renal or liver disease,
• acute lung injury or acute lung problem,
• coexisting open chest condition,
• severe bradycardia,
• patients with spontaneous breathing

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135710, South Korea

Location

Related Publications (1)

• Min JJ, Gil NS, Lee JH, Ryu DK, Kim CS, Lee SM. Predictor of fluid responsiveness in the 'grey zone': augmented pulse pressure variation through a temporary increase in tidal volume. Br J Anaesth. 2017 Jul 1;119(1):50-56. doi: 10.1093/bja/aex074.

  PMID: 28974059 DERIVED

MeSH Terms

Conditions

Genital Neoplasms, Female; Abdominal Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: January 12, 2016
• Study Start: September 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

KR (1)