Condition category
Surgery
Date applied
18/01/2011
Date assigned
17/02/2011
Last edited
17/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Maria Calvo Vecino

ORCID ID

Contact details

Calle Gran via del Este Nº80
Madrid
28031
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ECRYCHIL18012011CQ

Study information

Scientific title

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

Acronym

Study hypothesis

The intraoperatory optimisation of fluids guided with transoesophageal doppler monitorisation allows a decrease in the morbidity rate and resources comsumption.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

High risk surgical procedures under general anaesthesia

Intervention

Intervention group: transoesophageal doppler monitorisation
Control group: conventional monitorisation

The intervention group consists of cardiovascular continuous oesophageal Doppler monitoring during the surgical intervention, while in the control group the cardiovascular function is estimated measuring a series of haemodynamic-related variables such as arterial pressure, temperature or diuresis.

The follow up of both arms are observed until the hospital discharge for short term outcomes and by a clinical records review until the sixth month after the hospital discharge for long term outcomes.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Post-operative short term complications

Secondary outcome measures

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

Overall trial start date

01/01/2011

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

840

Participant 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

Recruitment start date

01/01/2011

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Calle Gran via del Este Nº80
Madrid
28031
Spain

Sponsor information

Organisation

Deltex Medical Ltd (Spain)

Sponsor details

C/ Doctor Casals
32
17246 Santa Cristina de Aro
Girona
17246
Spain

Sponsor type

Industry

Website

http://www.deltexmedical.com

Funders

Funder type

Industry

Funder name

Deltex Medical Ltd (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes