Post-COVID 19 Patients Undergoing Surgery

Covid19 Clinical Trial

Official title:

Post-COVID 19 Patients Undergoing Surgery: Determination of Residual Lung Abnormalities and Postoperative Adverse Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922931
• Other study ID #: PR(AG)346/2020
• Status: Completed
• Start date: June 30, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: June 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. So, we propose an observational study comparing postCOVID-19 patients with normal population (control group) undergoing surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: April 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 95 Years

Eligibility

Control group

Inclusion criteria.:

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

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

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.

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 SARS-CoV-2.

• Patients previously surgery for chest surgery

• Patients in current state of respiratory infection

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
Spain	Vall d´Hebron Research Institute VHIR	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of residual pulmonary alterations in post-COVID patients	1. Determination of residual pulmonary alterations using preoperative lung ultrasound and obtaining intraoperative compliance in postCOVID-19 patients undergoing surgery.	1 month
Primary	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.	1 month
Secondary	postoperative complications	Determine postoperative complications one month after surgery.	1 month