Post-COVID 19 Patients Undergoing Surgery

NCT ID: NCT04922931

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-04-05

Brief 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. 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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

scheduled surgery

Intervention Type: PROCEDURE

Patients undergoing scheduled surgery with lung ultrasound before surgery and determination of lung compliance during general anesthesia

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.

scheduled surgery

Intervention Type: PROCEDURE

Patients undergoing scheduled surgery with lung ultrasound before surgery and determination of lung compliance during general anesthesia

Interventions

scheduled surgery

Patients undergoing scheduled surgery with lung ultrasound before surgery and determination of lung compliance during general anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

-Patients over the age of 18 who did not have COVID-19 and who are going to undergo scheduled surgery

-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.

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susana González-Suárez, PhD

Role: PRINCIPAL_INVESTIGATOR

Vall d´Hebron Institut Research (VHIR)

Locations

Vall d´Hebron Research Institute VHIR

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35710326 (View on PubMed)

Other Identifiers

PR(AG)346/2020

Identifier Type: -

Identifier Source: org_study_id