Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.

Surgery Clinical Trial

Official title:

Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709252
• Other study ID #: 201134
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2016
• Last updated: March 10, 2016
• Start date: January 2011

Study information

• Verified date: March 2016
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Free univ Brussels
• Study type: Interventional

Clinical Trial Summary

Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one of the best parameter to predict fluid responsiveness in patients under general anaesthesia. Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the pneumoperitoneum has been recently seen suggested as a limitation to their interpretation. The aim of this observational study is to compare changes in ΔPP and PVI related to autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in patients undergoing elective surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

• American Society of Anesthesiologists (ASA) score I-II

• scheduled for elective abdominal laparoscopic surgery

• with written informed consent

• more than 18 years

• Body Mass Index < 40 kg.m-2

• no supraventricular arrhythmias

• no heart failure with ejection fraction <25 %

• no peripheral vascular

• no severe respiratory disease

• no end stage renal failure (creatinine clearance <30ml/min).

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pneumoperitoneum
• Surgery

Intervention

Device:
• PVI and deltaPP after trendelenburg position change
Comparison of hemodynamic parameters during surgery after position change

Locations

Country	Name	City	State
Belgium	Brugmann hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pleth variability index (in %)	Before/after trendelenburg positioning in laparoscopic surgery	5 minutes	No
Primary	Pulse Pressure variation (deltaPP) (in %)	Before/after trendelenburg positioning in laparoscopic surgery	5 minutes	No