COVID-19NCT06197282
Impact of COVID-19 on Surgical Outcomes
An observational study of COVID-19 and Surgical Outcomes, run by Kern Medical Center at 1 site in United States.
Trial summary
Following the introduction of the COVID-19 vaccination, elective surgeries have resumed, allowing for greater insight into the postoperative period and outcomes aims on-going COVID-19 infections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Surgical Outcomes, Postoperative Complications
- What is being tested?
- Major surgery involving general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 7,696 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2020to 1 Dec 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Participants who presented to Kern Medical Center, a high-volume tertiary referral center and safety net hospital located in Bakersfield, California between May 2020 to December 2022, who underwent a surgical procedure requiring general anesthesia. Participants were required to have a EHR documented SAR-CoV-2 PCR nasopharyngeal swab within one preoperatively. Study excludes surgical procedures using only MAC or local anesthesia as well as percutaneous endoscopic gastrostomy tube placement. A total of 7,696 patients were included, 420 tested positive for COVID-19 (7.6% were symptomatic and 4.8% were asymptomatic) and 7,276 tested negative (10.9% qualified as control).
Who may be able to join
- Documented SAR-CoV-2 PCR nasopharyngeal swab within 1 year of major surgical intervention requiring general anesthesia
Who cannot join
- Surgical procedures using solely MAC and/or local anesthesia. Additionally, percutaneous endoscopic gastrostomy tube placements were omitted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID-19 on Surgical Outcomes in Acute Care Service in a Community Hospital
Following the introduction of the COVID-19 vaccination, elective surgeries have resumed, allowing for greater insight into the postoperative period and outcomes aims on-going COVID-19 infections. This study aimed to evaluate risk factors of postoperative morbidity and mortality in patients who had surgery within one year of testing positive for COVID-19.
Read the detailed description
SARS-CoV-2 (COVID-19) has infected over 100,000,000 million people in the United States (US). During the "first wave" in the US, medical facilities were advised to limit operative exposure, stratify operative cases by both risk and urgency and cancel elective procedures.
With over 60% of the US population considered fully vaccinated as of May of 2020, elective surgeries resumed amid periodic outbreaks allowing for continued insight into the impact of COVID-19 on the postoperative recovery process. However, relative to the volume of data on active infections, there is far less concerning the sequelae of previous infections. Therefore, the purpose of this study is to analyze a safety net hospital's experience regarding postoperative complications in patients that underwent surgical procedures requiring general anesthesia within a year of testing positive for COVID-19.
This is a retrospective study from a high-volume tertiary referral center and safety net hospital in Bakersfield, California. After approval by the Institutional Review Board, the electronic health record (EHR) was queried for all positive COVID-19 patients that underwent a surgical procedure of any kind requiring general anesthesia from 5 May 2020 to 31 December 2022. A total of 7,696 patients met inclusion criteria. 420 tested positive for COVID-19. Participants were subdivided into three study groups defined as symptomatic COVID-19 infection, asymptomatic COVID-19 infection, and COVID-19 negative control group.
Individual chart review allowed for subclassification based on symptomatology, admission status, length of admission, American Society of Anesthesiologist Physical Status Classification System (ASA), qSOFA and GCS rating along with COVID-19 and surgical complications Patients were required to have a COVID-19 diagnosis within one year of surgery. Categorical variables assessed in participants included age, sex, BMI, race, ICU or DOU stay. Post-operative complications assessed for included hospital length of stay, 30-day mortality, 30-day readmission, cardiac arrest, septic shock, acute kidney injury, acute respiratory distress syndrome, deep vein, thrombosis, pulmonary embolism, respiratory failure and pneumonia.
Statistical analysis was completed by the institution's statistician. Using Fisher extract, ANOVA, univariate and multivariate logistic regression analyses, odds ratios and p-values were obtained to evaluate for statistically significant correlations between categorical variables.
- Conditions
- COVID-19, Surgical Outcomes, Postoperative Complications
- Being tested
- Major surgery involving general anesthesia
- Keywords
- Postoperative outcomes, COVID-19
- Medical subject headings
- COVID-19, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major surgery involving general anesthesiaProcedure or surgery
Also called Diagnostic Test: SAR-CoV-2 PCR nasopharyngeal swab
EHR documented SAR-CoV-2 PCR nasopharyngeal swab results confirming Covid-19 status within one year of undergoing surgical procedure at Kern Medical Center.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Positive, Symptomatic | Patients undergoing major surgery with a documented positive COVID19 test with in 1 year of surgery and were symptomatic for COVID19 at the time of testing. Receives: Procedure: Major surgery involving general anesthesia | |
| COVID-19 Positive, Asymptomatic | Patients undergoing major surgery with a documented positive COVID19 test with in 1 year of surgery and were asymptomatic for COVID19 at the time of testing as well as at the time of surgery. Receives: Procedure: Major surgery involving general anesthesia | |
| Control: COVID-19 Negative | Patients undergoing major surgery with documented COVID19 negative testing prior to procedure. Receives: Procedure: Major surgery involving general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complication rate
Post operative morbidity and mortality rate
Measured: 05/05/2020-12/01/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start5 May 2020
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 7,696 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Jones, Kern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197282
- Sponsor's protocol ID
- 22152
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 18 Jan 2024
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 on Surgical Outcomes in Acute Care Service in a Community Hospital
- ClinicalTrials.gov ID
- NCT06197282
- Acronym / sponsor ID
- 22152
- Conditions
- COVID-19, Surgical Outcomes, Postoperative Complications
- Keywords
- Postoperative outcomes, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,696 participants (actual)
- Lead sponsor
- Kern Medical CenterUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 9 Jan 2024 (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.
Following the introduction of the COVID-19 vaccination, elective surgeries have resumed, allowing for greater insight into the postoperative period and outcomes aims on-going COVID-19 infections. This study aimed to evaluate risk factors of postoperative morbidity and mortality in patients who had surgery within one year of testing positive for COVID-19.
Detailed description
SARS-CoV-2 (COVID-19) has infected over 100,000,000 million people in the United States (US). During the "first wave" in the US, medical facilities were advised to limit operative exposure, stratify operative cases by both risk and urgency and cancel elective procedures.
With over 60% of the US population considered fully vaccinated as of May of 2020, elective surgeries resumed amid periodic outbreaks allowing for continued insight into the impact of COVID-19 on the postoperative recovery process. However, relative to the volume of data on active infections, there is far less concerning the sequelae of previous infections. Therefore, the purpose of this study is to analyze a safety net hospital's experience regarding postoperative complications in patients that underwent surgical procedures requiring general anesthesia within a year of testing positive for COVID-19.
This is a retrospective study from a high-volume tertiary referral center and safety net hospital in Bakersfield, California. After approval by the Institutional Review Board, the electronic health record (EHR) was queried for all positive COVID-19 patients that underwent a surgical procedure of any kind requiring general anesthesia from 5 May 2020 to 31 December 2022. A total of 7,696 patients met inclusion criteria. 420 tested positive for COVID-19. Participants were subdivided into three study groups defined as symptomatic COVID-19 infection, asymptomatic COVID-19 infection, and COVID-19 negative control group.
Individual chart review allowed for subclassification based on symptomatology, admission status, length of admission, American Society of Anesthesiologist Physical Status Classification System (ASA), qSOFA and GCS rating along with COVID-19 and surgical complications Patients were required to have a COVID-19 diagnosis within one year of surgery. Categorical variables assessed in participants included age, sex, BMI, race, ICU or DOU stay. Post-operative complications assessed for included hospital length of stay, 30-day mortality, 30-day readmission, cardiac arrest, septic shock, acute kidney injury, acute respiratory distress syndrome, deep vein, thrombosis, pulmonary embolism, respiratory failure and pneumonia.
Statistical analysis was completed by the institution's statistician. Using Fisher extract, ANOVA, univariate and multivariate logistic regression analyses, odds ratios and p-values were obtained to evaluate for statistically significant correlations between categorical variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Positive, Symptomatic | – | Procedure: Major surgery involving general anesthesiaPatients undergoing major surgery with a documented positive COVID19 test with in 1 year of surgery and were symptomatic for COVID19 at the time of testing. |
| COVID-19 Positive, Asymptomatic | – | Procedure: Major surgery involving general anesthesiaPatients undergoing major surgery with a documented positive COVID19 test with in 1 year of surgery and were asymptomatic for COVID19 at the time of testing as well as at the time of surgery. |
| Control: COVID-19 Negative | – | Procedure: Major surgery involving general anesthesiaPatients undergoing major surgery with documented COVID19 negative testing prior to procedure. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who presented to Kern Medical Center, a high-volume tertiary referral center and safety net hospital located in Bakersfield, California between May 2020 to December 2022, who underwent a surgical procedure requiring general anesthesia. Participants were required to have a EHR documented SAR-CoV-2 PCR nasopharyngeal swab within one preoperatively. Study excludes surgical procedures using only MAC or local anesthesia as well as percutaneous endoscopic gastrostomy tube placement. A total of 7,696 patients were included, 420 tested positive for COVID-19 (7.6% were symptomatic and 4.8% were asymptomatic) and 7,276 tested negative (10.9% qualified as control).
Key inclusion criteria (1 listed)
- Documented SAR-CoV-2 PCR nasopharyngeal swab within 1 year of major surgical intervention requiring general anesthesia
Key exclusion criteria (1 listed)
- Surgical procedures using solely MAC and/or local anesthesia. Additionally, percutaneous endoscopic gastrostomy tube placements were omitted.
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 |
|---|---|---|
| Major surgery involving general anesthesiaAlso: Diagnostic Test: SAR-CoV-2 PCR nasopharyngeal swabEHR documented SAR-CoV-2 PCR nasopharyngeal swab results confirming Covid-19 status within one year of undergoing surgical procedure at Kern Medical Center. | Procedure or surgery | COVID-19 Positive, Asymptomatic, COVID-19 Positive, Symptomatic, Control: COVID-19 Negative |
Primary outcome
Surgical complication rate
Time frame: 05/05/2020-12/01/2022
Post operative morbidity and mortality rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and Surgical Outcomes, run by Kern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Jan 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complication rate (time frame: 05/05/2020-12/01/2022). 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 18 Jan 2024.