Efficacy of intraoperatory optimisation of fluids guided with transoesophageal doppler monitorisation
| ISRCTN | ISRCTN93543537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93543537 |
| Secondary identifying numbers | ECRYCHIL18012011CQ |
- Submission date
- 18/01/2011
- Registration date
- 17/02/2011
- Last edited
- 18/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose Maria Calvo Vecino
Scientific
Scientific
Calle Gran via del Este Nº80
Madrid
28031
Spain
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy of intraoperatory optimisation of fluids guided with transoesophageal doppler monitorisation: a multicentre randomised controlled trial |
| Study objectives | The intraoperatory optimisation of fluids guided with transoesophageal doppler monitorisation allows a decrease in the morbidity rate and resources comsumption. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2011 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 840 |
| Total final enrolment | 450 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
Calle Gran via del Este Nº80
Madrid
28031
Spain
28031
Spain
Sponsor information
Deltex Medical Ltd (Spain)
Industry
Industry
C/ Doctor Casals, 32
17246 Santa Cristina de Aro
Girona
17246
Spain
| Website | http://www.deltexmedical.com |
|---|---|
"ROR" |
https://ror.org/02skfv902 |
Funders
Funder type
Industry
Deltex Medical Ltd (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2018 | 18/12/2020 | Yes | No |
Editorial Notes
18/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
