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Clinical Trials/ISRCTN93543537
ISRCTN93543537
Completed
未知

Efficacy of intraoperatory optimisation of fluids guided with transoesophageal doppler monitorisation: a multicentre randomised controlled trial

Deltex Medical Ltd (Spain)0 sites450 target enrollmentFebruary 17, 2011

Overview

Phase
未知
Intervention
Not specified
Conditions
High risk surgical procedures under general anaesthesia
Sponsor
Deltex Medical Ltd (Spain)
Enrollment
450
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Registry
who.int
Start Date
February 17, 2011
End Date
December 31, 2011
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Deltex Medical Ltd (Spain)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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