Postoperative ComplicationsNCT05227573
PaO2 and Lung Function After Orthopedic Surgery
An observational study of Postoperative Complications and Orthopedic Disorder, run by Umeå University at 1 site in Sweden.
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 orthopedic surgery in the form of upper limb surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Orthopedic Disorder
- What is being tested?
- Orthopedic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 9 Feb 2022to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing shoulder or elbow surgery
Inclusion Criteria: Patients undergoing shoulder or elbow surgery -
Exclusion Criteria: Dementia or cognitive impairment that makes it impossible to participate in studies. Not willing to participate
-
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Dept of Surgery, University hospital
Umeå, Västerbotten County, 90185
Karl A Franklin, MD, prof, +46 90 7851256, karl.franklin@umu.se
About this study
Official title: Oxygen Partial Pressure and Lung Function After Orthopedic Surgery
Hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal surgery. This study aims to investigate whether similar changes also occur after orthopedic surgery in the form of upper limb surgery.
Inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery.
Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.
Arterial blood gas and lung function are undertaken before surgery, the day after surgery and at follow-up.
Read the 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 including obstructive sleep apnea. The cause of postoperative restrictive lung function and hypoxia is unknown. Previous studies report that PaO2 decreases by an average of 2 kPa after abdominal surgery, while PaCO2 is unchanged and vital capacity decreases by 35%. The effect of orthopedic surgery on oxygen and carbon dioxide partial pressure and lung function has previously not been investigated. This study aims to investigate possible changes in oxygen partial pressure and vital capacity after orthopedic surgery.
Design: Prospective cohort study
Inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery..
Exclusion: Dementia or cognitive impairment that makes it impossible to 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 34 patients if the mean (SD) difference is 1 (2) kPa. Due to drop-outs the investigators calculate a need to include 60 patients.
Primary outcome measures:
- PaO2 from atrial blood gas
Secondary outcomes
- Vital capacity
- PaCO2 from atrial blood gas
- Forced expiratory volume in one second (FEV1)
Other variables examined: age, sex, height, weight, type of surgery, type of anesthesia, smoking status, length of surgery and previous diseases
- Conditions
- Postoperative Complications, Orthopedic Disorder
- Being tested
- Orthopedic surgery
- Medical subject headings
- Postoperative Complications, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopedic surgeryProcedure or surgery
Knee-, hip-, shoulder- and elbow surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen partial pressure
Change in oxygen partial pressure after surgery
Measured: 1 day
Secondary outcomes (7)
Vital capacity
Change in vital capacity after surgery
Measured: 1 day
Oxygen partial pressure
Change in oxygen partial pressure after surgery
Measured: 1 month
Carbon dioxide partial pressure
Change in carbon dioxide partial pressure after surgery
Measured: 1 day
Carbon dioxide partial pressure
Change in carbon dioxide partial pressure after surgery
Measured: 1 month
Vital capacity
Change in vital capacity after surgery
Measured: 1 month
Forced expiratory volume in one second
Change in Forced expiratory volume in one second after surgery
Measured: 1 day
Forced expiratory volume in one second
Change in Forced expiratory volume in one second after surgery
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start9 Feb 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl A Franklin, Umeå University
- Investigators
- Karl A Franklin, Prof, Principal investigator, Surgical and Perioperative Sciences, Surgery, Umeå University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227573
- Sponsor's protocol ID
- 233
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Partial Pressure and Lung Function After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT05227573
- Acronym / sponsor ID
- 233
- Conditions
- Postoperative Complications, Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal surgery. This study aims to investigate whether similar changes also occur after orthopedic surgery in the form of upper limb surgery.
Inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery.
Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.
Arterial blood gas and lung function are undertaken before surgery, the day after surgery and at follow-up.
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 including obstructive sleep apnea. The cause of postoperative restrictive lung function and hypoxia is unknown. Previous studies report that PaO2 decreases by an average of 2 kPa after abdominal surgery, while PaCO2 is unchanged and vital capacity decreases by 35%. The effect of orthopedic surgery on oxygen and carbon dioxide partial pressure and lung function has previously not been investigated. This study aims to investigate possible changes in oxygen partial pressure and vital capacity after orthopedic surgery.
Design: Prospective cohort study
Inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery..
Exclusion: Dementia or cognitive impairment that makes it impossible to 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 34 patients if the mean (SD) difference is 1 (2) kPa. Due to drop-outs the investigators calculate a need to include 60 patients.
Primary outcome measures:
- PaO2 from atrial blood gas
Secondary outcomes
- Vital capacity
- PaCO2 from atrial blood gas
- Forced expiratory volume in one second (FEV1)
Other variables examined: age, sex, height, weight, type of surgery, type of anesthesia, smoking status, length of surgery and previous diseases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing shoulder or elbow surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopedic surgeryKnee-, hip-, shoulder- and elbow surgery | Procedure or surgery | – |
Primary outcome
Oxygen partial pressure
Time frame: 1 day
Change in oxygen partial pressure after surgery
7 secondary outcomes
Vital capacity
Time frame: 1 day
Oxygen partial pressure
Time frame: 1 month
Carbon dioxide partial pressure
Time frame: 1 day
Carbon dioxide partial pressure
Time frame: 1 month
Vital capacity
Time frame: 1 month
Forced expiratory volume in one second
Time frame: 1 day
Forced expiratory volume in one second
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl A Franklin, Prof principal investigator
Surgical and Perioperative Sciences, Surgery, Umeå University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Orthopedic Disorder, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl A Franklin, Prof (+46 706884745, karl.franklin@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen partial pressure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.