Covid19NCT04922931
Post-COVID 19 Patients Undergoing Surgery
An observational study of Covid19, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
More and more patients are undergoing elective surgery after SARS-CoV-2 infection, and little is known about the residual pulmonary changes in these patients after infection and postoperative pulmonary complications. Read more about this study
- Who is it for?
- Ages 19 to 95 years
- Conditions the study is for
- Covid19
- What is being tested?
- scheduled surgery
- Type of treatment
- Surgery or procedure
- How many people
- 207 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2020to 5 Apr 2021
- How long will I take part?
- 1 Month
- 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 19 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The written consent forms are obtained from all the subjects who agreed to participate in the study. Patients who suffered Covid-19 prior to surgery without previous moderate-severe pulmonary pathology, that at the time of surgery present negative PCR and absence of clinic due to SARS-CoV-2, are included in the Post-COVID 19 group. The "control group" includes patients over the age of 18 who did not have COVID-19 and without moderate-severe pulmonary pathology prior to surgery.
Who may be able to join
- -Patients over the age of 18 who did not have COVID-19 and who are going to undergo scheduled surgery
Who cannot join
- Patients under the age of 18.
- Unstable patients in shock
- Patients in current state of pulmonary hypertension or heart failure
- Patients with moderate-severe pulmonary pathology prior to surgery.
- Patients previously surgery for chest surgery
- Patients in current state of respiratory infection
Show all 14Show fewer
- Post-COVID group Inclusion criteria
- -Post-COVID-19 patients (confirmed by PCR) >18 years undergoing scheduled surgery without pulmonary disease prior to SARS-CoV-2 infection, that at the time of surgery present negative PCR and absence of clinic due to SARS-CoV-2 infection.
- Patients under the age of 18
- Unstable patients in shock
- Patients in current state of pulmonary hypertension or heart failure
- Patients with moderate-severe pulmonary pathology prior to SARS-CoV-2.
- Patients previously surgery for chest surgery
- Patients in current state of respiratory infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-COVID 19 Patients Undergoing Surgery: Determination of Residual Lung Abnormalities and Postoperative Adverse Effects
More and more patients are undergoing elective surgery after SARS-CoV-2 infection, and little is known about the residual pulmonary changes in these patients after infection and postoperative pulmonary complications. So, we propose an observational study comparing postCOVID-19 patients with normal population (control group) undergoing surgery.
Read the detailed description
The most common lung complications of severe COVID-19 are pneumonia and hypoxemic respiratory failure/ARDS. Manifestations of lung inflammation or fibrosis were also observed in late stages of COVID-19 causing respiratory sequelae. Fibrous lesions may form during the healing of pulmonary chronic inflammation or proliferative diseases, with gradual replacement of cellular components by scar tissues indicating a poor outcome of COVID-19. Ultrasound allows to stratify the severity of lung damage and combined with the clinic, can help estimate the patient's prognosis and support therapeutic decision-making. On the other hand, pulmonary inflammatory processes and fibrosis are responsible for a decrease in respiratory distensibility or pulmonary compliance. Pulmonary parenchyma distensibility is known as static distensibility or compliance and it´s calculated by mechanical ventilators during general anesthesia.
There are no studies that determine the results of lung ultrasound and pulmonary compliance in preoperative and intraoperative period respectively in postCOVID patients, and the postoperative complications of postCOVID patients are poorly understood.
- Conditions
- Covid19
- Being tested
- scheduled surgery
- Keywords
- Post-COVID patients, pulmonary sequelae, postoperative complications
- 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.
scheduled surgeryProcedure or surgery
Patients undergoing scheduled surgery with lung ultrasound before surgery and determination of lung compliance during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Post-COVID-19 group | The Post-COVID-19 group or case group includes post-COVID patients (confirmed by PCR) >18 years undergoing scheduled surgery without pulmonary disease prior to SARS-CoV-2 infection that at the time of surgery present negative PCR and absence of clinic due to SARS-CoV-2. Receives: Procedure: scheduled surgery | |
| Control group | The control group includes patients over the age of 18 who did not have COVID-19 and without moderate-severe pulmonary pathology prior to surgery and in conditions of hemodynamic and respiratory stability at time of surgery. Receives: Procedure: scheduled surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of residual pulmonary alterations in post-COVID patients
- Determination of residual pulmonary alterations using preoperative lung ultrasound and obtaining intraoperative compliance in postCOVID-19 patients undergoing surgery.
Measured: 1 month
Correlation between lung ultrasound and pulmonary compliance
Analyze the correlation between the values obtained with pulmonary ultrasound and the pulmonary compliance obtained by mechanical ventilation in patients with general anesthesia.
Measured: 1 month
Secondary outcomes (1)
postoperative complications
Determine postoperative complications one month 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 posted11 Jun 2021
- Study start30 Jun 2020
- Primary completion5 Mar 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Prospective
- Enrolment
- 207 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana González-Suárez, PhD, Principal investigator, Vall d´Hebron Institut Research (VHIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922931
- Sponsor's protocol ID
- PR(AG)346/2020
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Suarez S, Barbara Ferreras A, Caicedo Toro M, Aznar de Legarra M. Detection of residual pulmonary alterations with lung ultrasound and effects on postoperative pulmonary complications for patients with asymptomatic SARS-CoV-2 infection undergoing surgeries. BMC Anesthesiol. 2022 Jun 16;22(1):186. doi: 10.1186/s12871-022-01715-4.
PubMed 35710326
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-COVID 19 Patients Undergoing Surgery: Determination of Residual Lung Abnormalities and Postoperative Adverse Effects
- ClinicalTrials.gov ID
- NCT04922931
- Acronym / sponsor ID
- PR(AG)346/2020
- Conditions
- Covid19
- Keywords
- Post-COVID patients, pulmonary sequelae, postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 11 Jun 2021 (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.
More and more patients are undergoing elective surgery after SARS-CoV-2 infection, and little is known about the residual pulmonary changes in these patients after infection and postoperative pulmonary complications. So, we propose an observational study comparing postCOVID-19 patients with normal population (control group) undergoing surgery.
Detailed description
The most common lung complications of severe COVID-19 are pneumonia and hypoxemic respiratory failure/ARDS. Manifestations of lung inflammation or fibrosis were also observed in late stages of COVID-19 causing respiratory sequelae. Fibrous lesions may form during the healing of pulmonary chronic inflammation or proliferative diseases, with gradual replacement of cellular components by scar tissues indicating a poor outcome of COVID-19. Ultrasound allows to stratify the severity of lung damage and combined with the clinic, can help estimate the patient's prognosis and support therapeutic decision-making. On the other hand, pulmonary inflammatory processes and fibrosis are responsible for a decrease in respiratory distensibility or pulmonary compliance. Pulmonary parenchyma distensibility is known as static distensibility or compliance and it´s calculated by mechanical ventilators during general anesthesia.
There are no studies that determine the results of lung ultrasound and pulmonary compliance in preoperative and intraoperative period respectively in postCOVID patients, and the postoperative complications of postCOVID patients are poorly understood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-COVID-19 group | – | Procedure: scheduled surgeryThe Post-COVID-19 group or case group includes post-COVID patients (confirmed by PCR) >18 years undergoing scheduled surgery without pulmonary disease prior to SARS-CoV-2 infection that at the time of surgery present negative PCR and absence of clinic due to SARS-CoV-2. |
| Control group | – | Procedure: scheduled surgeryThe control group includes patients over the age of 18 who did not have COVID-19 and without moderate-severe pulmonary pathology prior to surgery and in conditions of hemodynamic and respiratory stability at time of surgery. |
Who may qualify
- Ages
- 19 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The written consent forms are obtained from all the subjects who agreed to participate in the study. Patients who suffered Covid-19 prior to surgery without previous moderate-severe pulmonary pathology, that at the time of surgery present negative PCR and absence of clinic due to SARS-CoV-2, are included in the Post-COVID 19 group. The "control group" includes patients over the age of 18 who did not have COVID-19 and without moderate-severe pulmonary pathology prior to surgery.
Key inclusion criteria (1 listed)
- -Patients over the age of 18 who did not have COVID-19 and who are going to undergo scheduled surgery
Key exclusion criteria (14 listed)
- Patients under the age of 18.
- Unstable patients in shock
- Patients in current state of pulmonary hypertension or heart failure
- Patients with moderate-severe pulmonary pathology prior to surgery.
- Patients previously surgery for chest 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 |
|---|---|---|
| scheduled surgeryPatients undergoing scheduled surgery with lung ultrasound before surgery and determination of lung compliance during general anesthesia | Procedure or surgery | Control group, Post-COVID-19 group |
Primary outcome
Determination of residual pulmonary alterations in post-COVID patients
Time frame: 1 month
1. Determination of residual pulmonary alterations using preoperative lung ultrasound and obtaining intraoperative compliance in postCOVID-19 patients undergoing surgery.
Correlation between lung ultrasound and pulmonary compliance
Time frame: 1 month
Analyze the correlation between the values obtained with pulmonary ultrasound and the pulmonary compliance obtained by mechanical ventilation in patients with general anesthesia.
1 secondary outcome
postoperative complications
Time frame: 1 month
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 2 Sep 2021.
- Derived from this study: PubMed 35710326Gonzalez-Suarez S, Barbara Ferreras A, Caicedo Toro M, Aznar de Legarra M. Detection of residual pulmonary alterations with lung ultrasound and effects on postoperative pulmonary complications for patients with asymptomatic SARS-CoV-2 infection undergoing surgeries. BMC Anesthesiol. 2022 Jun 16;22(1):186. doi: 10.1186/s12871-022-01715-4.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Active, not recruitingObservational study
A Study to Learn About COVID-19 Antivirals in People With SARS-CoV-2 Infection From 2023-2026
COVID-19 SARS-CoV-2 Infection
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
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.
Susana González-Suárez, PhD principal investigator
Vall d´Hebron Institut Research (VHIR)
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 Covid19, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 14 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 2 Sep 2021. 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 Spain. 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?
Determination of residual pulmonary alterations in post-COVID patients (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922931, which also lists 1 linked publication.
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 2 Sep 2021.