Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy

NCT ID: NCT02653469

Last Updated: 2016-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-02-29

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Augmented ventilation

Intervention Type: 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.

Fluid loading

Intervention Type: OTHER

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

Interventions

Augmented ventilation

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.

Intervention Type: OTHER

Fluid loading

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

Intervention Type: OTHER

Other Intervention Names

Balanced crystalloid infusion

Eligibility Criteria

Inclusion Criteria

• Adult patients undergoing elective open laparotomy surgery.

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jong Hwan Lee

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 28974059 (View on PubMed)

Other Identifiers

SMC 2015-06-015

Identifier Type: -

Identifier Source: org_study_id