Regional Versus General Anesthesia for Hip Fracture and Postoperative Oxygenation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hip-fracture, General Anaesthesia, Regional Anaesthesia. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Oxygenation index (SpO2/FiO2 ratio) [Time frame: first postoperative day]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- hospital admission for hip fracture;
- scheduled for hip fracture surgery;
- age above 65 years, both genders;
- capable of consent or consent by responsible person;
Exclusion criteria
- hip fracture during hospitalization (not present upon admission)
- patient refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Portugal · 1 center
- Northern Lisbon Hospital Center — Lisbon
Identifiers
NCT: NCT07309575 · CE-CAML 221/25