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| Name | Class |
|---|---|
| Northern Lisbon Hospital Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anaesthesia | Hip fracture surgery under general anaesthesia | ||
| Rregional anaesthesia | Hip fracture surgery under regional anaesthesia |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | first postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Apnea index | average dips of SpO2 per hour, (>= 4%) | first postoperative day |
| Length of stay in the Post-anestesia Care Unit | Length of stay in the Post-anestesia Care Unit |
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Inclusion Criteria:
Exclusion Criteria:
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Elder subjects with hip-fracture submitted to surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Lisbon Hospital Center | Recruiting | Lisbon | Lisbon District | 1635 | Portugal |
only anonymised data can be shared after publication and upon reasonable request
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| 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 | from hospital admission to hospital discharge, approximatelly 5 days |
| postoperative pulmonary complications | postoperative pulmonary complications defined as hypoxemia, respiratory failure, atelectasis, pneumothorax, respiratory infection. | during the first postoperative day |
| Delirium | Presence of delirium in the first postoperative day | during the first postoperative day |
| in-Hospital mortality | death from any cause during hospital stay, from hospital admission to discharge | From hospital admission to hospital discharge (or death), up to 3 months |
| D007869 |
| Leg Injuries |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |