Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737446
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2023-02-10
Brief Title:
Oxygen Partial Pressure After Breast Cancer Surgery
Sponsor:
Umeå University
Organization:
Umeå University
Study Overview
Official Title:
Oxygen Partial Pressure After Breast Cancer Surgery
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 05 1 kilopascal Due to drop-outs the investigators calculate a need to include up to 60 patients
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 05 1 kilopascal Due to drop-outs the investigators calculate a need to include up to 60 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None