Post-COVID 19 Patients Undergoing Surgery

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04922931
Collaborator
(none)
207
1
9.2
22.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: scheduled 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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
207 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-COVID 19 Patients Undergoing Surgery: Determination of Residual Lung Abnormalities and Postoperative Adverse Effects
Actual Study Start Date :
Jun 30, 2020
Actual Primary Completion Date :
Mar 5, 2021
Actual Study Completion Date :
Apr 5, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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.

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. postoperative complications [1 month]

    Determine postoperative complications one month after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vall d´Hebron Research Institute VHIR Barcelona Spain 08035

Sponsors and Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Susana González-Suárez, PhD, Vall d´Hebron Institut Research (VHIR)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT04922931
Other Study ID Numbers:
  • PR(AG)346/2020
First Posted:
Jun 11, 2021
Last Update Posted:
Sep 2, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2021