Regional Versus General Anesthesia for Hip Fracture and Postoperative Oxygenation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Lisbon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
hospital admission for hip fracture;
scheduled for hip fracture surgery;
age above 65 years, both genders;
capable of consent or consent by responsible person;
Disqualifiers
hip fracture during hospitalization (not present upon admission)
patient refusal to participate
Trial population
Elder subjects with hip-fracture submitted to surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
102 Participants
are grouped into 2 trial groupsGroup A: General anaesthesia
Group B: Rregional anaesthesia
Trial outcomes
Primary outcomes
1
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 daySecondary outcomes
1
Sleep Apnea index
average dips of SpO2 per hour, (\>= 4%)
Time frame
first postoperative day2
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 Unit3
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 days4
postoperative pulmonary complications
postoperative pulmonary complications defined as hypoxemia, respiratory failure, atelectasis, pneumothorax, respiratory infection.
Time frame
during the first postoperative daySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Lisbon
Lead sponsor
Northern Lisbon Hospital Center
Collaborator
Source ClinicalTrials.gov