Efficacy of intraoperatory optimisation of fluids guided with transoesophageal doppler monitorisatio

Not Applicable

Completed

• Conditions: Surgery; High risk surgical procedures under general anaesthesia; General anaesthesia

• Registration Number: ISRCTN93543537
• Lead Sponsor: Deltex Medical Ltd (Spain)

Brief Summary

2018 results in https://pubmed.ncbi.nlm.nih.gov/29576114/ (added 18/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-17
• Study Completion: 2011-12-31
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Patient is under general anaesthesia
2. Major surgery with more than 2 hours
3. Estimated volume loss superior to 15% of volemia
4. Procedure with estimated transfusion need of 2 units of blood substitute
5. High risk surgical procedures in urology, gynaecology, abdominal surgery and traumalogy
6. Aged 18 years or over, either sex

Exclusion Criteria

1. Patient aged less than 18 years
2. High risk surgical procedures with unforeseen complications
3. Severe bleeding
4. Nasal or facial trauma
5. Trauma preventing proper insertion of the product (probe)
6. Oesophageal anomalies such as stenosis, oesophageal varices with risk of rupture, severe oesophagitis
7. Oesophageal stents
8. Oesophageal tumour
9. Surgery at the level of the oesophagus or upper airway
10. Pneumo a/o cardiopathy that needs treatment before surgery
11. American Society of Anaesthesiology (ASA) grade IV - V

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative short term complications

Secondary Outcome Measures

Name	Time	Method
<br> Measured all along the hospital stay:<br> 1. Hospital length of stay<br> 2. Morbidity and mortality, also measured at the sixth month after hospital discharge<br>