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

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2015-001788-37-FI
• Date of registration: 26/06/2015
• Prospective Registration: Yes
• Primary sponsor: Heart Center Co. Tampere University Hospital
• Public title: Effects of volume changes to the plethysmography signal on major surgery patients
• Scientific title: Effects of volume changes to the plethysmography signal on major surgery patients
• Date of first enrolment: 29/06/2015
• Target sample size: 40
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001788-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Patients are their own controls Number of treatment arms in the trial: 1

Countries of recruitment

Finland

Contacts

• Name: Research Unit
• Affiliation: Heart Center Co. Tampere University Hospital

• Name: Research Unit
• Affiliation: Heart Center Co. Tampere University Hospital

Key inclusion & exclusion 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 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

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

Intervention(s)

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(s)/litre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

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.

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 Outcome(s)

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.

Secondary ID(s)

HCA-2015-2

Source(s) of Monetary Support

Heart Center Co. Tampere Univesity Hospital