Regional Versus General Anesthesia for Hip Fracture and Postoperative Oxygenation

NCT07309575 | Recruiting

• 1 other identifier: CE-CAML 221/25
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

General Anaesthesia; Regional Anaesthesia; Hip-fracture

Keywords

anaesthesia; hip femur fracture; postoperative pulmonary complications; oxygenation; sleep apnea

Outcome Measures

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.

  first postoperative day

Secondary Outcomes (6)

• Sleep Apnea index

  first postoperative day

• Length of stay in the Post-anestesia Care Unit

  after the surgery, at discharge from the Post-anestesia Care Unit

• Hospital Length of Stay (Days)

  from hospital admission to hospital discharge, approximatelly 5 days

• postoperative pulmonary complications

  during the first postoperative day

• Delirium

  during the first postoperative day

Study Arms (2)

General anaesthesia

Hip fracture surgery under general anaesthesia

Rregional anaesthesia

Hip fracture surgery under regional anaesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elder subjects with hip-fracture submitted to surgery.

You may qualify if:

• hospital admission for hip fracture;
• scheduled for hip fracture surgery;
• age above 65 years, both genders;
• capable of consent or consent by responsible person;

You may not qualify if:

• hip fracture during hospitalization (not present upon admission)
• patient refusal to participate

Sponsors & Collaborators

• University of Lisbon: lead
• Northern Lisbon Hospital Center: collaborator

Study Sites (1)

Northern Lisbon Hospital Center

Lisbon, Lisbon District, 1635, Portugal

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD PhD

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 30, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)