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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001788-37-FI

Enrollment

Registered

2015-06-26

Start date

2015-06-29

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients scheduled for elective CABG (Coronary artery bypass surgery). Patients scheduled for elective open major abdominal surgery (gastrointestinal surgery). MedDRA version: 18.0 Level: LLT Classification code 10011090 Term: Coronary artery surgery System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.0 Level: PT Classification code 10068093 Term: Gastrointestinal surgery System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Albuman 40 g/l Product Name: Albuman 40 g/l Product Code: Vnr 051531 Pharmaceutical Form: Infusion INN or Proposed INN: ALBUMIN Other descriptive name: ALBUMIN Concentration unit: g/l gram

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Finland

Contacts

Public ContactResearch Unit

Heart Center Co. Tampere University Hospital

research@sydansairaala.fi+3583311 65038

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026