Post-COVID 19 Patients Undergoing Surgery

Completed

• Conditions: Covid19
• Interventions: Procedure: scheduled surgery

• Registration Number: NCT04922931
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study Start: 2020-06-30
• Primary Completion: 2021-03-05
• Study Completion: 2021-04-05
• Status Verified: 2021-06
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-11
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-COVID-19 group	scheduled surgery	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.
Control group	scheduled surgery	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.

Primary Outcome Measures

Name	Time	Method
Correlation between lung ultrasound and pulmonary compliance	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.
Determination of residual pulmonary alterations in post-COVID patients	1 month	1. Determination of residual pulmonary alterations using preoperative lung ultrasound and obtaining intraoperative compliance in postCOVID-19 patients undergoing surgery.

Secondary Outcome Measures

Name	Time	Method
postoperative complications	1 month	Determine postoperative complications one month after surgery.

Trial Locations

Locations (1)

Vall d´Hebron Research Institute VHIR; 🇪🇸 Barcelona, Spain