Oxygen Partial Pressure After Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

Oxygen Partial Pressure After Breast Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737446
• Other study ID #: 07068-02
• Status: Recruiting
• Start date: February 23, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: Umeå University
• Contact: Karl A Franklin, MD, Prof
• Phone: +46 70 6884745
• Email: karl.franklin[@]umu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hypoxia

Locations

Country	Name	City	State
Sweden	Dept of Surgery, University hospital	Umeå	Vasterbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen partial pressure	Change in oxygen partial pressure after surgery	1 day
Secondary	Carbon dioxide partial pressure	Change in carbon dioxide partial pressure after surgery	1 day
Secondary	Vital capacity	Change in vital capacity after surgery	1 day
Secondary	Forced expiratory volume in 1 second (FEV1)	Change in FEV1 after surgery	1 day