Post-COVID 19 Patients Undergoing Surgery

NCT04922931 | Completed DMC

• 1 other identifier: PR(AG)346/2020
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Post-COVID patients; pulmonary sequelae; postoperative complications

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• postoperative complications

  1 month

Study Arms (2)

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.

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.

Procedure: scheduled surgery

Interventions

scheduled surgery PROCEDURE

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

Control group; Post-COVID-19 group

Eligibility Criteria

• Age: 19 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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-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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall d´Hebron Research Institute VHIR

Barcelona, 08035, Spain

Location

Related Publications (1)

• 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.

  PMID: 35710326 DERIVED

MeSH Terms

Conditions

COVID-19; Postoperative Complications

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Susana González-Suárez, PhD

  Vall d´Hebron Institut Research (VHIR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 11, 2021
• Study Start: June 30, 2020
• Primary Completion: March 5, 2021
• Study Completion: April 5, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)