An observational study in Hip-fracture, General Anaesthesia and Regional Anaesthesia, sponsored by University of Lisbon. Recruiting at 1 site in Portugal. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by University of Lisbon · Observational
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.
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.
842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.
This study's planned enrollment of 102 is below the median of 149 across 280 observational studies indexed under Hip Fractures.
Browse Hip Fractures studies →University of Lisbon is the lead sponsor of 40 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Elder subjects with hip-fracture submitted to surgery.
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Exclusion Criteria:
Hip fracture surgery under general anaesthesia
Hip fracture surgery under regional anaesthesia
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.
Time frame: first postoperative day
Sleep Apnea index
average dips of SpO2 per hour, (\>= 4%)
Time frame: first postoperative day
Length of stay in the Post-anestesia Care Unit
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)
Length of stay in the hospital from admission until discharge, in days
Time frame: from hospital admission to hospital discharge, approximatelly 5 days
postoperative pulmonary complications
postoperative pulmonary complications defined as hypoxemia, respiratory failure, atelectasis, pneumothorax, respiratory infection.
Time frame: during the first postoperative day
Delirium
Presence of delirium in the first postoperative day
Time frame: during the first postoperative day
in-Hospital mortality
death from any cause during hospital stay, from hospital admission to discharge
Time frame: From hospital admission to hospital discharge (or death), up to 3 months
Plan to share: No — only anonymised data can be shared after publication and upon reasonable request
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2026, 13 months after the start.
Of 107 non-industry observational studies under Hip Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 65. This study's planned 13 months is below that.
Counting every sponsor, half of 124 studies reached it within 28 months; a quarter within 12 and three quarters within 83.
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University of Lisbon