Thoracic SurgeryNCT03805880
Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery
An observational study of Thoracic Surgery and Cognitive Dysfunction, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The purpose of this study prospective observational study is to determine cognitive dysfunction incidence after thoracic surgery. We also evaluate evaluate the role of cerebral oxygen desaturations and hypertension as risk factors for post-operative cognitive dysfunction (POCD) in patients undergoing lung resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Cognitive Dysfunction
- What is being tested?
- cerebral desaturation monitoring and cognitive examination
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for elective lobectomy or wedge resection via thoracotomy requiring an OLV duration ≥ 45 min
Who may be able to join
- patients scheduled for elective lobectomy or wedge resection via thoracotomy
- one lung ventilation (OLV duration) ≥ 45 min
Who cannot join
- previous cerebral disease,
- dementia,
- severe cognitive dysfunction
- emergency surgery
- pregnancy
- patient refusal to give consent
Show all 9Show fewer
- inability to give consent
- age ≤18 years
- ASA ≥ IV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Desaturation During One Lung-ventilation and Postoperative Dysfunction Afterthoracic Surgery: a Prospective Observational Study
The purpose of this study prospective observational study is to determine cognitive dysfunction incidence after thoracic surgery. We also evaluate evaluate the role of cerebral oxygen desaturations and hypertension as risk factors for post-operative cognitive dysfunction (POCD) in patients undergoing lung resection.
- Conditions
- Thoracic Surgery, Cognitive Dysfunction
- Being tested
- cerebral desaturation monitoring and cognitive examination
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral desaturation monitoring and cognitive examinationDiagnostic test
Before general anesthesia, continuous monitoring of cerebral oxygenation(rSO2) was started using an INVOS 5100 (Somaneic, Tro, MI) .Patient cognitive function was assessed using Mini-Mental State Examination (MMSE) on the day before surgery (baseline) and then after 1 day after surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of cognitive dysfunction after thoracic surgery
A decrease in Mini-Mental State Examination (MMSE) score > 2 points from baseline was defined as Postoperative cognitive dysfunction (POCD)
Measured: change of MMSE score from the day before surgery (baseline) at 1 day after surgery
Secondary outcomes (2)
role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection.
monitoring values of cerebral saturation during intraoperative period:Cerebral desaturation was defined as a reduction of rSO2 during OLV of more than 20% from the baseline value
Measured: change of cerebral saturation from baseline(before surgery) at intraoperative measure
role of hypertension as risk factors for POCD in patients undergoing lung resection.
monitoring values of blood pressure during intraoperative period
Measured: change of blood pressure from baseline(before surgery) at intraoperative measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Jan 2018
- Primary completion31 Mar 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Fiorelli, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805880
- Sponsor's protocol ID
- SATURIMETRIA
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Desaturation During One Lung-ventilation and Postoperative Dysfunction Afterthoracic Surgery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03805880
- Acronym / sponsor ID
- SATURIMETRIA
- Conditions
- Thoracic Surgery, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 16 Jan 2019 (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.
The purpose of this study prospective observational study is to determine cognitive dysfunction incidence after thoracic surgery. We also evaluate evaluate the role of cerebral oxygen desaturations and hypertension as risk factors for post-operative cognitive dysfunction (POCD) in patients undergoing lung resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for elective lobectomy or wedge resection via thoracotomy requiring an OLV duration ≥ 45 min
Key inclusion criteria (2 listed)
- patients scheduled for elective lobectomy or wedge resection via thoracotomy
- one lung ventilation (OLV duration) ≥ 45 min
Key exclusion criteria (9 listed)
- previous cerebral disease,
- dementia,
- severe cognitive dysfunction
- emergency surgery
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cerebral desaturation monitoring and cognitive examinationBefore general anesthesia, continuous monitoring of cerebral oxygenation(rSO2) was started using an INVOS 5100 (Somaneic, Tro, MI) .Patient cognitive function was assessed using Mini-Mental State Examination (MMSE) on the day before surgery (baseline) and then after 1 day after surgery. | Diagnostic test | – |
Primary outcome
incidence of cognitive dysfunction after thoracic surgery
Time frame: change of MMSE score from the day before surgery (baseline) at 1 day after surgery
A decrease in Mini-Mental State Examination (MMSE) score > 2 points from baseline was defined as Postoperative cognitive dysfunction (POCD)
2 secondary outcomes
role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection.
Time frame: change of cerebral saturation from baseline(before surgery) at intraoperative measure
role of hypertension as risk factors for POCD in patients undergoing lung resection.
Time frame: change of blood pressure from baseline(before surgery) at intraoperative measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thoracic Surgery and Cognitive Dysfunction, run by University of Roma La Sapienza at 1 site in Italy.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 16 Jan 2019. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of cognitive dysfunction after thoracic surgery (time frame: change of MMSE score from the day before surgery (baseline) at 1 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2019.