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Trial Title:
Oxygen Partial Pressure After Breast Cancer Surgery
NCT ID:
NCT05737446
Condition:
Breast Cancer
Surgery-Complications
Hypoxia
Conditions: Official terms:
Breast Neoplasms
Hypoxia
Conditions: Keywords:
Breast cancer surgery
postoperative hypoxia
Lung function
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal
surgery. This study aims to investigate whether similar changes also occur after breast
cancer surgery.
Inclusion: 60 women undergoing breast cancer surgery. Exclusion: Dementia or cognitive
impairment that makes it impossible to participate in the study.
Arterial blood gas and lung function are undertaken before surgery and the day after
surgery
Detailed description:
Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular
risk for postoperative pulmonary complications including severe hypoxia are those who
undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic
lung disease. The cause of postoperative hypoxia and reduced lung function is unknown.
Previous studies report that arterial partial pressure (PaO2) decreased by an average of
2 kilopascal after abdominal surgery, while carbon dioxide partial pressure (PaCO2) was
unchanged and vital capacity decreased by 35%. The effect of breast cancer surgery on
oxygen and carbon dioxide partial pressure and lung function has to the best of the
investigators knowledge not been investigated. This study aims to investigate possible
changes in oxygen partial pressure, carbon-dioxide partial pressure and vital capacity
after breast cancer surgery.
Design: Prospective cohort study participate in studies. Method: Blood gas measurements
and Lung function (Vital capacity and FEV1) The day before surgery, the day after surgery
and at follow-up.
Power analysis: There is a need to investigate 27 patients if the mean (SD) difference is
0.5 (1) kilopascal. Due to drop-outs the investigators calculate a need to include up to
60 patients.
Criteria for eligibility:
Study pop:
Women with breast cancer scheduled for surgery.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
• Women scheduled for surgery because of breast cancer.
Exclusion Criteria:
• Dementia or cognitive impairment that makes it impossible to participate in the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dept of Surgery, University hospital
Address:
City:
Umeå
Zip:
90185
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Karl A Franklin, MD, prof
Phone:
+46 90 7851256
Email:
karl.franklin@umu.se
Start date:
February 23, 2023
Completion date:
June 1, 2024
Lead sponsor:
Agency:
Umeå University
Agency class:
Other
Source:
Umeå University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737446
