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OpenTrials
Completed

NCT Number: NCT04922931

Post-COVID 19 Patients Undergoing Surgery

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Postoperative Complications RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vall d´Hebron Research Institute VHIR

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

scheduled surgery

Procedure

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

Primary outcomes

  1. Determination of residual pulmonary alterations in post-COVID patients

    Time frame: 1 month

    • 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

    Time frame: 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 outcomes

  1. postoperative complications

    Time frame: 1 month

    Determine postoperative complications one month after surgery.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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