Oxygen Partial Pressure After Breast Cancer Surgery

Sponsor

Umeå University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05737446

Collaborator

(none)

Enrollment

15.2

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Surgery-Complications Hypoxia

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Oxygen Partial Pressure After Breast Cancer Surgery

Anticipated Study Start Date :

Feb 23, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Outcome Measures

Primary Outcome Measures

Oxygen partial pressure [1 day]
Change in oxygen partial pressure after surgery

Secondary Outcome Measures

Carbon dioxide partial pressure [1 day]
Change in carbon dioxide partial pressure after surgery
Vital capacity [1 day]
Change in vital capacity after surgery
Forced expiratory volume in 1 second (FEV1) [1 day]
Change in FEV1 after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Umeå University

Investigators

Principal Investigator: Karl A Franklin, MD, Prof, Dept Surgery, University hospital, Umea, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Umeå University

ClinicalTrials.gov Identifier:

NCT05737446

Other Study ID Numbers:

07068-02

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Umeå University

Breast cancer surgery

postoperative hypoxia

Lung function

Additional relevant MeSH terms:

Breast Neoplasms

Hypoxia

Study Results

No Results Posted as of Feb 23, 2023