E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients scheduled for elective CABG (Coronary artery bypass surgery). Patients scheduled for elective open major abdominal surgery (gastrointestinal surgery). |
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E.1.1.1 | Medical condition in easily understood language |
Coronary artery bypass surgery and gastrointestinal surgery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011090 |
E.1.2 | Term | Coronary artery surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10068093 |
E.1.2 | Term | Gastrointestinal surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.2 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Patients are their own controls |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |