Hip-fractureREGENERATIONNCT07309575
Regional Versus General Anesthesia for Hip Fracture and Postoperative Oxygenation
An observational study of Hip-fracture and General Anaesthesia, run by University of Lisbon at 1 site in Portugal.
Trial summary
With this study, the investigators intend to measure oxygen saturation before and after hip surgery in the context of proximal femur fracture, comparing two types of anesthesia (general or spinal). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip-fracture, General Anaesthesia, Regional Anaesthesia
- How many people
- 102 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Nov 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elder subjects with hip-fracture submitted to surgery.
Who may be able to join
- hospital admission for hip fracture;
- scheduled for hip fracture surgery;
- age above 65 years, both genders;
- capable of consent or consent by responsible person;
Who cannot join
- hip fracture during hospitalization (not present upon admission)
- patient refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Northern Lisbon Hospital Center
Lisbon, Lisbon District, 1635
Andre dos Santos Rocha, MD, PhD, +351 969 345 052, andrerocha@medicina.ulisboa.pt
About this study
With this study, the investigators intend to measure oxygen saturation before and after hip surgery in the context of proximal femur fracture, comparing two types of anesthesia (general or spinal). The investigators also intend to study the effects of the two anesthetic techniques on sleep apnea, delirium, respiratory complications, and length of hospital stay.
This is an observational study, in which oxygen is measured at the fingertip with a sensor and a bracelet, without any intervention, inconvenience, or discomfort for the participant. Data will be collected on: respiratory complications, sleep apnea, delirium, length of hospital stay, and survival.
Read more
Data will be collected in the operating room and wards of Santa Maria Hospital, Lisbon, Portugal over a period of approximately 24 hours after the participant's operation. Information about participant's health and co-morbidities will be recorded.
There will be no implication for the participants' clinical care, since the study measurements will not be sent to the health professionals in charge. The operation, recovery, and treatments will not be influenced at any time by participation in the study.
Read the detailed description
Frailty, comorbidities, medication (anticoagulants and anti-platellet agents) as well as acute and chronic illnesses have an impact on the choice of anesthesia strategy for hip fracture surgery. The choice between general anesthesia (GA) and loco-regional, spinal anesthesia (SA) may have impact on the postoperative period. Despite previous retrospective studies on this topic, it remains uncertain that either is superior in terms of post-operative outcomes, including mortality, delirium and respiratory complications, with conflicting results in the literature.
Postoperative pulmonary complications (PPC) are amongst the commonest complications in geriatric hip fractures, reported to be around 12%. The elder population at Hospital de Santa Maria (Tertiary University Hospital Center) receives the most challenging cases, with pilot data from the past 3 years (2022-2024, n=927) revealing an average risk score for PPC of 32,1%.
Considering that low oxygen saturation is an independent risk factor and a strong predictor for PPC, the investigators seek to compare the oxygenation during the perioperative period between the different anesthesia regimens.
The study hypothesis is that the anesthesia regimen (GA vs SA) has an impact on the oxygenation index during the first 24 postoperative hours.
The secondary objectives are to compare the sleep apnea index between GA and SA, the incidence of PPC, delirium, mortality and the length of stay (LOS) in the PACU and until discharge from the hospital.
- Conditions
- Hip-fracture, General Anaesthesia, Regional Anaesthesia
- Keywords
- anaesthesia, hip femur fracture, postoperative pulmonary complications, oxygenation, sleep apnea
- Medical subject headings
- Hip Fractures, Sleep Apnea Syndromes
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 |
|---|---|---|
| General anaesthesia | Hip fracture surgery under general anaesthesia | |
| Rregional anaesthesia | Hip fracture surgery under regional anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index (SpO2/FiO2 ratio)
Oxygenation index (SpO2/FiO2 ratio) measured as the difference between oxygenation index on admission to the operating room and the mean SpO2 during the next 24 postoperative hours, compared between groups.
Peripheral oxygen saturation measured continuously during the first postoperative day with the Konica Minolta PULSOX-DS5® device.
Measured: first postoperative day
Secondary outcomes (6)
Sleep Apnea index
average dips of SpO2 per hour, (>= 4%)
Measured: first postoperative day
Length of stay in the Post-anestesia Care Unit
Length of stay in the Post-anestesia Care Unit
Measured: after the surgery, at discharge from the Post-anestesia Care Unit
Hospital Length of Stay (Days)
Length of stay in the hospital from admission until discharge, in days
Measured: from hospital admission to hospital discharge, approximatelly 5 days
postoperative pulmonary complications
postoperative pulmonary complications defined as hypoxemia, respiratory failure, atelectasis, pneumothorax, respiratory infection.
Measured: during the first postoperative day
Delirium
Presence of delirium in the first postoperative day
Measured: during the first postoperative day
in-Hospital mortality
death from any cause during hospital stay, from hospital admission to discharge
Measured: From hospital admission to hospital discharge (or death), up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start27 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip-fractureStudies 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Lisbon Hospital Center
- Responsible party
- Principal investigator, ANDRE DOS SANTOS ROCHA, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309575
- Sponsor's protocol ID
- CE-CAML 221/25
- Acronym
- REGENERATION
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only anonymised data can be shared after publication and upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Versus General Anesthesia for Hip Fracture and Postoperative Oxygenation
- ClinicalTrials.gov ID
- NCT07309575
- Acronym / sponsor ID
- REGENERATION / CE-CAML 221/25
- Conditions
- Hip-fracture, General Anaesthesia, Regional Anaesthesia
- Keywords
- anaesthesia, hip femur fracture, postoperative pulmonary complications, oxygenation, sleep apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- Northern Lisbon Hospital Center
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (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.
With this study, the investigators intend to measure oxygen saturation before and after hip surgery in the context of proximal femur fracture, comparing two types of anesthesia (general or spinal). The investigators also intend to study the effects of the two anesthetic techniques on sleep apnea, delirium, respiratory complications, and length of hospital stay.
This is an observational study, in which oxygen is measured at the fingertip with a sensor and a bracelet, without any intervention, inconvenience, or discomfort for the participant. Data will be collected on: respiratory complications, sleep apnea, delirium, length of hospital stay, and survival.
Data will be collected in the operating room and wards of Santa Maria Hospital, Lisbon, Portugal over a period of approximately 24 hours after the participant's operation. Information about participant's health and co-morbidities will be recorded.
There will be no implication for the participants' clinical care, since the study measurements will not be sent to the health professionals in charge. The operation, recovery, and treatments will not be influenced at any time by participation in the study.
Detailed description
Frailty, comorbidities, medication (anticoagulants and anti-platellet agents) as well as acute and chronic illnesses have an impact on the choice of anesthesia strategy for hip fracture surgery. The choice between general anesthesia (GA) and loco-regional, spinal anesthesia (SA) may have impact on the postoperative period. Despite previous retrospective studies on this topic, it remains uncertain that either is superior in terms of post-operative outcomes, including mortality, delirium and respiratory complications, with conflicting results in the literature.
Postoperative pulmonary complications (PPC) are amongst the commonest complications in geriatric hip fractures, reported to be around 12%. The elder population at Hospital de Santa Maria (Tertiary University Hospital Center) receives the most challenging cases, with pilot data from the past 3 years (2022-2024, n=927) revealing an average risk score for PPC of 32,1%.
Considering that low oxygen saturation is an independent risk factor and a strong predictor for PPC, the investigators seek to compare the oxygenation during the perioperative period between the different anesthesia regimens.
The study hypothesis is that the anesthesia regimen (GA vs SA) has an impact on the oxygenation index during the first 24 postoperative hours.
The secondary objectives are to compare the sleep apnea index between GA and SA, the incidence of PPC, delirium, mortality and the length of stay (LOS) in the PACU and until discharge from the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anaesthesia | – | –Hip fracture surgery under general anaesthesia |
| Rregional anaesthesia | – | –Hip fracture surgery under regional anaesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elder subjects with hip-fracture submitted to surgery.
Key inclusion criteria (4 listed)
- hospital admission for hip fracture;
- scheduled for hip fracture surgery;
- age above 65 years, both genders;
- capable of consent or consent by responsible person;
Key exclusion criteria (2 listed)
- hip fracture during hospitalization (not present upon admission)
- patient refusal to participate
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
Oxygenation index (SpO2/FiO2 ratio)
Time frame: first postoperative day
Oxygenation index (SpO2/FiO2 ratio) measured as the difference between oxygenation index on admission to the operating room and the mean SpO2 during the next 24 postoperative hours, compared between groups. Peripheral oxygen saturation measured continuously during the first postoperative day with the Konica Minolta PULSOX-DS5® device.
6 secondary outcomes
Sleep Apnea index
Time frame: first postoperative day
Length of stay in the Post-anestesia Care Unit
Time frame: after the surgery, at discharge from the Post-anestesia Care Unit
Hospital Length of Stay (Days)
Time frame: from hospital admission to hospital discharge, approximatelly 5 days
postoperative pulmonary complications
Time frame: during the first postoperative day
Delirium
Time frame: during the first postoperative day
in-Hospital mortality
Time frame: From hospital admission to hospital discharge (or death), up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No. only anonymised data can be shared after publication and upon reasonable request
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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.
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 Hip-fracture and General Anaesthesia, run by University of Lisbon at 1 site in Portugal.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation index (SpO2/FiO2 ratio) (time frame: first postoperative day). 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 30 Dec 2025.