EsophagectomyERASENCT04750096
Esophagectomy Enhanced Recovery After Surgery Protocol
An observational study of Esophagectomy, run by Raquel Ferrandis Comes at 1 site in Spain.
Trial summary
Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in esophagectomy reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophagectomy
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing esophagectomy due to oesophageal cancer.
Who may be able to join
- Patients undergone esophagectomy due to neoplastic causes
- Ages between 18 and 90
- Programmed surgery
Who cannot join
- Caustic esophagitis
- Esophagectomy for stomach cancer
- Congenital oesophageal malformations
- Respiratory failure at the time of surgery
- Re-interventions of esophagectomy
- Unexpected intraoperative surgical problems
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
La Fe University and Polytechnic Hospital
Valencia, 46026
Silvia Polo, Medical specialist, + 34 690 85 39 26, silpomar@mail.ucv.es
Raquel Ferrandis, Medical Specialist
About this study
Official title: Respiratory Failure in Esophagectomy. Results After Implantation of Enhanced Recovery After Surgery Protocol.
Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in esophagectomy reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Factors that have been associated with the development of respiratory failure in the literature include among others the presence of previous respiratory pathology, history of smoking, malnutrition and rescue surgery.
With the aim of improving morbimortality in patients undergoing esophagectomy, a multidisciplinary protocol based on the best scientific evidence at the present time has been implemented, with actions covering both the preoperative and postoperative areas. Based on this point, a prospective study has been designed that allows us to compare the incidence of respiratory failure before and after the implementation of the protocol.
Read the detailed description
Esophageal carcinoma is the sixth leading cause of cancer death worldwide and the main treatment still remains oesophagectomy, a technique associated with a high morbidity and mortality rate. Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in these patients reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Factors that have been associated with the development of respiratory failure in the literature include among others the presence of previous respiratory pathology, history of smoking, malnutrition and rescue surgery.
With the aim of improving morbimortality in patients undergoing oesophagectomy, a multidisciplinary protocol based on the best scientific evidence at the present time has been implemented, with actions covering both the preoperative and postoperative areas. Based on this point, a prospective study has been designed that allows us to compare the incidence of respiratory failure before and after the implementation of the protocol.
The secondary objectives are to analyse the changes produced in terms of morbimortality after the implementation of the protocol and the repercussion of these changes on the length of stay in the Resuscitation Unit.
To carry out this project, data obtained in the first instance from patients operated before the implementation of the enhanced recovery after surgery protocol will be compared with data obtained prospectively after the implementation of the protocol.
The data will be collected from the computerised and digitalised medical records of the patients on Orion Clinic® and Interspace intelligence Critical Care and Anesthesia, Philips ®. Patients operated on between 19 October 2020 and 19 October 2021 will be included consecutively. Prior to the operation, patients must sign an informed consent form to authorize the monitoring of their data during the first 30 days after the operation. These data will include:
- Days of stay
- Development or not of respiratory failure on initial admission, as well as the ventilatory therapy used (non-invasive and invasive) and days of mechanical ventilation
- Fluid balance at 24 hours
- Adequate completion of the protocol on a post-operative basis. The items of the protocol completed during the postoperative period will be detailed, taking into account the following points:
- Use of epidural analgesia
- Adequate pain control
- Realisation of neutral or negative balances
- Introduction of enteral nutrition by jejunostomy
- Performance of respiratory physiotherapy
- Use of high-flow nasal glasses with a minimum flow of 40 litres.
- Start of sedation on the second post-operative day
- Antithrombotic prophylaxis
- The need or not for new drains and the reason for their installation will also be collected in order to evaluate the effectiveness of the transhiatal drains included in our protocol.
Data regarding re-entry will be collected on
- Reason for re-entry
- Evolutionary day after surgery when readmission took place (day 1 being counted as the day of esophagectomy)
- Days in the Critical Care Unit
- Development or not of respiratory insufficiency, and in positive cases, requirement of invasive or non-invasive mechanical ventilation and days of therapy with it.
Finally, the morbidity and mortality variables will be collected:
- Respiratory complications: pleural effusion, atelectasis, pneumothorax, pneumonia, adult respiratory distress syndrome (ARDS).
- The development of complications other than respiratory ones.
- The need for reintervention and the underlying cause.
- If exits occur, as well as the cause of death in hospital or in the first 30 days after surgery.
The data will be analysed using Statistical Package for the Social Sciences software ® (version 12).
- Conditions
- Esophagectomy
- Keywords
- Esophagectomy, enhanced recovery after surgery, acute lung injury
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Esophagectomy post enhanced recovery after surgery | Patients undergoing esophagectomy due to oesophageal cancer under Enhanced Recovery After Surgery protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative respiratory failure
Post-operative respiratory failure in esophagectomy after introduction of Enhanced Recovery After Surgery protocol
Measured: 1 month
Secondary outcomes (4)
Other morbidity
Analyse changes in terms of morbidity and mortality different from respiratory failure following the implementation of the protocol. It will allow us to know the impact of the measures carried out on complications and mortality.
Measured: 1 month
Stay at ICU
Changes produced in the resuscitation stay after the Enhanced Recovery After Surgery protocol.
Measured: 1 month
Main predisposing factors
Main predisposing factors for the development of respiratory insufficiency.
Measured: 1 month
Respiratory failure as a prognostic factor
Analyse the presence of respiratory failure as a prognostic factor. This allows us to know the impact of respiratory failure on the evolution of the patient.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raquel Ferrandis Comes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raquel Ferrandis Comes, Instituto de Investigacion Sanitaria La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750096
- Sponsor's protocol ID
- ERASE 001
- Acronym
- ERASE
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Low DE, Kuppusamy MK, Alderson D, Cecconello I, Chang AC, Darling G, Davies A, D'Journo XB, Gisbertz SS, Griffin SM, Hardwick R, Hoelscher A, Hofstetter W, Jobe B, Kitagawa Y, Law S, Mariette C, Maynard N, Morse CR, Nafteux P, Pera M, Pramesh CS, Puig S, Reynolds JV, Schroeder W, Smithers M, Wijnhoven BPL. Benchmarking Complications Associated with Esophagectomy. Ann Surg. 2019 Feb;269(2):291-298. doi: 10.1097/SLA.0000000000002611.
PubMed 29206677Takeuchi H, Miyata H, Ozawa S, Udagawa H, Osugi H, Matsubara H, Konno H, Seto Y, Kitagawa Y. Comparison of Short-Term Outcomes Between Open and Minimally Invasive Esophagectomy for Esophageal Cancer Using a Nationwide Database in Japan. Ann Surg Oncol. 2017 Jul;24(7):1821-1827. doi: 10.1245/s10434-017-5808-4. Epub 2017 Feb 21.
PubMed 28224366van Adrichem EJ, Meulenbroek RL, Plukker JT, Groen H, van Weert E. Comparison of two preoperative inspiratory muscle training programs to prevent pulmonary complications in patients undergoing esophagectomy: a randomized controlled pilot study. Ann Surg Oncol. 2014 Jul;21(7):2353-60. doi: 10.1245/s10434-014-3612-y. Epub 2014 Mar 7.
PubMed 24604584Armestar F, Mesalles E, Font A, Arellano A, Roca J, Klamburg J, Fernandez-Llamazares J. [Serious postoperative complications after esophagectomy for esophageal carcinoma: analysis of risk factors]. Med Intensiva. 2009 Jun-Jul;33(5):224-32. doi: 10.1016/s0210-5691(09)71756-5. Spanish.
PubMed 19624996Liu F, Wang W, Wang C, Peng X. Enhanced recovery after surgery (ERAS) programs for esophagectomy protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2018 Feb;97(8):e0016. doi: 10.1097/MD.0000000000010016.
PubMed 29465538Findlay JM, Gillies RS, Millo J, Sgromo B, Marshall RE, Maynard ND. Enhanced recovery for esophagectomy: a systematic review and evidence-based guidelines. Ann Surg. 2014 Mar;259(3):413-31. doi: 10.1097/SLA.0000000000000349.
PubMed 24253135Lagarde SM, Maris AK, de Castro SM, Busch OR, Obertop H, van Lanschot JJ. Evaluation of O-POSSUM in predicting in-hospital mortality after resection for oesophageal cancer. Br J Surg. 2007 Dec;94(12):1521-6. doi: 10.1002/bjs.5850.
PubMed 17929231van der Sluis PC, Schizas D, Liakakos T, van Hillegersberg R. Minimally Invasive Esophagectomy. Dig Surg. 2020;37(2):93-100. doi: 10.1159/000497456. Epub 2019 May 16.
PubMed 31096214Lv L, Hu W, Ren Y, Wei X. Minimally invasive esophagectomy versus open esophagectomy for esophageal cancer: a meta-analysis. Onco Targets Ther. 2016 Oct 31;9:6751-6762. doi: 10.2147/OTT.S112105. eCollection 2016.
PubMed 27826201Palanivelu C, Prakash A, Senthilkumar R, Senthilnathan P, Parthasarathi R, Rajan PS, Venkatachlam S. Minimally invasive esophagectomy: thoracoscopic mobilization of the esophagus and mediastinal lymphadenectomy in prone position--experience of 130 patients. J Am Coll Surg. 2006 Jul;203(1):7-16. doi: 10.1016/j.jamcollsurg.2006.03.016.
PubMed 16798482Kinugasa S, Tachibana M, Yoshimura H, Ueda S, Fujii T, Dhar DK, Nakamoto T, Nagasue N. Postoperative pulmonary complications are associated with worse short- and long-term outcomes after extended esophagectomy. J Surg Oncol. 2004 Nov 1;88(2):71-7. doi: 10.1002/jso.20137.
PubMed 15499604Ferguson MK, Celauro AD, Prachand V. Prediction of major pulmonary complications after esophagectomy. Ann Thorac Surg. 2011 May;91(5):1494-1500; discussion 1500-1. doi: 10.1016/j.athoracsur.2010.12.036.
PubMed 21524462Kobayashi S, Kanetaka K, Nagata Y, Nakayama M, Matsumoto R, Takatsuki M, Eguchi S. Predictive factors for major postoperative complications related to gastric conduit reconstruction in thoracoscopic esophagectomy for esophageal cancer: a case control study. BMC Surg. 2018 Mar 6;18(1):15. doi: 10.1186/s12893-018-0348-9.
PubMed 29510754Biere SS, van Berge Henegouwen MI, Bonavina L, Rosman C, Roig Garcia J, Gisbertz SS, van der Peet DL, Cuesta MA. Predictive factors for post-operative respiratory infections after esophagectomy for esophageal cancer: outcome of randomized trial. J Thorac Dis. 2017 Jul;9(Suppl 8):S861-S867. doi: 10.21037/jtd.2017.06.61.
PubMed 28815084Law S, Wong KH, Kwok KF, Chu KM, Wong J. Predictive factors for postoperative pulmonary complications and mortality after esophagectomy for cancer. Ann Surg. 2004 Nov;240(5):791-800. doi: 10.1097/01.sla.0000143123.24556.1c.
PubMed 15492560
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Failure in Esophagectomy. Results After Implantation of Enhanced Recovery After Surgery Protocol.
- ClinicalTrials.gov ID
- NCT04750096
- Acronym / sponsor ID
- ERASE / ERASE 001
- Conditions
- Esophagectomy
- Keywords
- Esophagectomy, enhanced recovery after surgery, acute lung injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Raquel Ferrandis ComesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in esophagectomy reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Factors that have been associated with the development of respiratory failure in the literature include among others the presence of previous respiratory pathology, history of smoking, malnutrition and rescue surgery.
With the aim of improving morbimortality in patients undergoing esophagectomy, a multidisciplinary protocol based on the best scientific evidence at the present time has been implemented, with actions covering both the preoperative and postoperative areas. Based on this point, a prospective study has been designed that allows us to compare the incidence of respiratory failure before and after the implementation of the protocol.
Detailed description
Esophageal carcinoma is the sixth leading cause of cancer death worldwide and the main treatment still remains oesophagectomy, a technique associated with a high morbidity and mortality rate. Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in these patients reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Factors that have been associated with the development of respiratory failure in the literature include among others the presence of previous respiratory pathology, history of smoking, malnutrition and rescue surgery.
With the aim of improving morbimortality in patients undergoing oesophagectomy, a multidisciplinary protocol based on the best scientific evidence at the present time has been implemented, with actions covering both the preoperative and postoperative areas. Based on this point, a prospective study has been designed that allows us to compare the incidence of respiratory failure before and after the implementation of the protocol.
The secondary objectives are to analyse the changes produced in terms of morbimortality after the implementation of the protocol and the repercussion of these changes on the length of stay in the Resuscitation Unit.
To carry out this project, data obtained in the first instance from patients operated before the implementation of the enhanced recovery after surgery protocol will be compared with data obtained prospectively after the implementation of the protocol.
The data will be collected from the computerised and digitalised medical records of the patients on Orion Clinic® and Interspace intelligence Critical Care and Anesthesia, Philips ®. Patients operated on between 19 October 2020 and 19 October 2021 will be included consecutively. Prior to the operation, patients must sign an informed consent form to authorize the monitoring of their data during the first 30 days after the operation. These data will include:
- Days of stay
- Development or not of respiratory failure on initial admission, as well as the ventilatory therapy used (non-invasive and invasive) and days of mechanical ventilation
- Fluid balance at 24 hours
- Adequate completion of the protocol on a post-operative basis. The items of the protocol completed during the postoperative period will be detailed, taking into account the following points:
- Use of epidural analgesia
- Adequate pain control
- Realisation of neutral or negative balances
- Introduction of enteral nutrition by jejunostomy
- Performance of respiratory physiotherapy
- Use of high-flow nasal glasses with a minimum flow of 40 litres.
- Start of sedation on the second post-operative day
- Antithrombotic prophylaxis
- The need or not for new drains and the reason for their installation will also be collected in order to evaluate the effectiveness of the transhiatal drains included in our protocol.
Data regarding re-entry will be collected on
- Reason for re-entry
- Evolutionary day after surgery when readmission took place (day 1 being counted as the day of esophagectomy)
- Days in the Critical Care Unit
- Development or not of respiratory insufficiency, and in positive cases, requirement of invasive or non-invasive mechanical ventilation and days of therapy with it.
Finally, the morbidity and mortality variables will be collected:
- Respiratory complications: pleural effusion, atelectasis, pneumothorax, pneumonia, adult respiratory distress syndrome (ARDS).
- The development of complications other than respiratory ones.
- The need for reintervention and the underlying cause.
- If exits occur, as well as the cause of death in hospital or in the first 30 days after surgery.
The data will be analysed using Statistical Package for the Social Sciences software ® (version 12).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophagectomy post enhanced recovery after surgery | – | –Patients undergoing esophagectomy due to oesophageal cancer under Enhanced Recovery After Surgery protocol. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing esophagectomy due to oesophageal cancer.
Key inclusion criteria (3 listed)
- Patients undergone esophagectomy due to neoplastic causes
- Ages between 18 and 90
- Programmed surgery
Key exclusion criteria (6 listed)
- Caustic esophagitis
- Esophagectomy for stomach cancer
- Congenital oesophageal malformations
- Unexpected intraoperative surgical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-operative respiratory failure
Time frame: 1 month
Post-operative respiratory failure in esophagectomy after introduction of Enhanced Recovery After Surgery protocol
4 secondary outcomes
Other morbidity
Time frame: 1 month
Stay at ICU
Time frame: 1 month
Main predisposing factors
Time frame: 1 month
Respiratory failure as a prognostic factor
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Background: PubMed 29206677Low DE, Kuppusamy MK, Alderson D, Cecconello I, Chang AC, Darling G, Davies A, D'Journo XB, Gisbertz SS, Griffin SM, Hardwick R, Hoelscher A, Hofstetter W, Jobe B, Kitagawa Y, Law S, Mariette C, Maynard N, Morse CR, Nafteux P, Pera M, Pramesh CS, Puig S, Reynolds JV, Schroeder W, Smithers M, Wijnhoven BPL. Benchmarking Complications Associated with Esophagectomy. Ann Surg. 2019 Feb;269(2):291-298. doi: 10.1097/SLA.0000000000002611.
- Background: PubMed 28224366Takeuchi H, Miyata H, Ozawa S, Udagawa H, Osugi H, Matsubara H, Konno H, Seto Y, Kitagawa Y. Comparison of Short-Term Outcomes Between Open and Minimally Invasive Esophagectomy for Esophageal Cancer Using a Nationwide Database in Japan. Ann Surg Oncol. 2017 Jul;24(7):1821-1827. doi: 10.1245/s10434-017-5808-4. Epub 2017 Feb 21.
- Background: PubMed 24604584van Adrichem EJ, Meulenbroek RL, Plukker JT, Groen H, van Weert E. Comparison of two preoperative inspiratory muscle training programs to prevent pulmonary complications in patients undergoing esophagectomy: a randomized controlled pilot study. Ann Surg Oncol. 2014 Jul;21(7):2353-60. doi: 10.1245/s10434-014-3612-y. Epub 2014 Mar 7.
- Background: PubMed 19624996Armestar F, Mesalles E, Font A, Arellano A, Roca J, Klamburg J, Fernandez-Llamazares J. [Serious postoperative complications after esophagectomy for esophageal carcinoma: analysis of risk factors]. Med Intensiva. 2009 Jun-Jul;33(5):224-32. doi: 10.1016/s0210-5691(09)71756-5. Spanish.
- Background: PubMed 29465538Liu F, Wang W, Wang C, Peng X. Enhanced recovery after surgery (ERAS) programs for esophagectomy protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2018 Feb;97(8):e0016. doi: 10.1097/MD.0000000000010016.
- Background: PubMed 24253135Findlay JM, Gillies RS, Millo J, Sgromo B, Marshall RE, Maynard ND. Enhanced recovery for esophagectomy: a systematic review and evidence-based guidelines. Ann Surg. 2014 Mar;259(3):413-31. doi: 10.1097/SLA.0000000000000349.
- Background: PubMed 17929231Lagarde SM, Maris AK, de Castro SM, Busch OR, Obertop H, van Lanschot JJ. Evaluation of O-POSSUM in predicting in-hospital mortality after resection for oesophageal cancer. Br J Surg. 2007 Dec;94(12):1521-6. doi: 10.1002/bjs.5850.
- Background: PubMed 31096214van der Sluis PC, Schizas D, Liakakos T, van Hillegersberg R. Minimally Invasive Esophagectomy. Dig Surg. 2020;37(2):93-100. doi: 10.1159/000497456. Epub 2019 May 16.
- Background: PubMed 27826201Lv L, Hu W, Ren Y, Wei X. Minimally invasive esophagectomy versus open esophagectomy for esophageal cancer: a meta-analysis. Onco Targets Ther. 2016 Oct 31;9:6751-6762. doi: 10.2147/OTT.S112105. eCollection 2016.
- Background: PubMed 16798482Palanivelu C, Prakash A, Senthilkumar R, Senthilnathan P, Parthasarathi R, Rajan PS, Venkatachlam S. Minimally invasive esophagectomy: thoracoscopic mobilization of the esophagus and mediastinal lymphadenectomy in prone position--experience of 130 patients. J Am Coll Surg. 2006 Jul;203(1):7-16. doi: 10.1016/j.jamcollsurg.2006.03.016.
- Background: PubMed 15499604Kinugasa S, Tachibana M, Yoshimura H, Ueda S, Fujii T, Dhar DK, Nakamoto T, Nagasue N. Postoperative pulmonary complications are associated with worse short- and long-term outcomes after extended esophagectomy. J Surg Oncol. 2004 Nov 1;88(2):71-7. doi: 10.1002/jso.20137.
- Background: PubMed 21524462Ferguson MK, Celauro AD, Prachand V. Prediction of major pulmonary complications after esophagectomy. Ann Thorac Surg. 2011 May;91(5):1494-1500; discussion 1500-1. doi: 10.1016/j.athoracsur.2010.12.036.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagectomy, run by Raquel Ferrandis Comes at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Polo, Medical specialist (+34 690 85 39 26, silpomar@mail.ucv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative respiratory failure (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750096, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.