Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy

Gynecologic Neoplasms Clinical Trial

Official title:

Pulse Pressure Variation With Augmented Ventilation to Predict Fluid Responsiveness in the Patients Undergoing Open Laparotomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653469
• Other study ID #: SMC 2015-06-015
• Status: Completed
• Phase: N/A
• First received: October 20, 2015
• Last updated: March 2, 2016
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Genital Neoplasms, Female
• Gynecologic Neoplasms
• Neoplasms

Intervention

Other:
• 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.
• Fluid loading
We record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Conventional baseline PPV to predict fluid responsiveness	PPV value will be collected automatically by Intelivue philips patient monitor.	when patients PPV in grey zone, before augmented ventilation	No