Oxygen Partial Pressure After Breast Cancer Surgery

NCT ID: NCT05737446

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-23
• Study Completion Date: 2024-06-01

Brief 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.

Conditions

Breast Cancer; Surgery-Complications; Hypoxia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl A Franklin, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Dept Surgery, University hospital, Umea, Sweden

Locations

Dept of Surgery, University hospital

Umeå, Västerbotten County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Karl A Franklin, MD, Prof

Role: CONTACT

karl.franklin@umu.se

+46 70 6884745

Magnus Hultin, MD, Ass Prof

Role: CONTACT

magnus.hultin@umu.se

+46 70 3505335

Facility Contacts

Karl A Franklin, MD, prof

Role: primary

karl.franklin@umu.se

+46 90 7851256

Other Identifiers

07068-02

Identifier Type: -

Identifier Source: org_study_id