Effects of volume changes to the plethysmography signal on major surgery patients

Conditions: Patients scheduled for elective CABG (Coronary artery bypass surgery). Patients scheduled for elective open major abdominal surgery (gastrointestinal surgery).
MedDRA version: 18.0Level: LLTClassification code 10011090Term: Coronary artery surgerySystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 18.0Level: PTClassification code 10068093Term: Gastrointestinal surgerySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-001788-37-FI

Lead Sponsor: Heart Center Co. Tampere University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

Age between 18 and 80 years, ASA I-III , preoperative LVEF > 50% or not known previous heart failure, sinus rhythm. Estimated duration of surgery is more than1.5 hours but less than 8 hours.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Exclusion criteria are disease or medication affecting central nervous system or peripheral nervous system. History of alcohol or drug abuse. Body mass index over 35. Jehovah´s witness who cannot accept albumin.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our primary endpoint in this study is to find a correlation between plethysmography signals and volume changes from different SpO2 measurement sites like fingertip, ear lope and nasal septum. ;Secondary Objective: 1) Which pleth site has the best respiratory modulation signal for the purpose of assessment of the patient fluid status? 2)Which pleth site signal predicts best the fluid response? 3)Secondary endpoint is the effect of mild hypothermia to these signals.;Primary end point(s): Our primary endpoint in this study is to find a correlation between plethysmography signals and volume changes from different SpO2 measurement sites like fingertip, ear lope and nasal septum.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Which pleth site has the best respiratory modulation signal for the purpose of assessment of the patient fluid status? 2)Which pleth site signal predicts best the fluid response? 3)Secondary endpoint is the effect of mild hypothermia to these signals.