Preoperative Laboratory Parameters and Scorings Systems on Postoperative Pulmonary Complications in Thoracic Surgery

February 15, 2022 updated by: Gulay Ulger, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Evaluation of the Effects of Preoperative Neutrophil/Lymphocyte Ratio, Albumin Level, and Various Risk Scorings on Postoperative Pulmonary Complications in Thoracic Surgery. Prospective Observational Study

Postoperative pulmonary complications (PPC) emerge as a major risk that determines the morbidity and mortality of patients after surgery. PPCs affect the length of hospital stay and increase health costs. Because of this reason, it is important to predict PPCs before surgery. There are many studies on scoring systems that can be effective in predicting PPCs. The most frequently used ones are the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk index, the Nutritional Risk Score (NRS), and the American Society of Anesthesiologist (ASA) score. ARISCAT risk index is mostly evaluated in operations performed other than thoracic surgery. Since the thoracic wall, mediastinum or lungs are directly intervened in thoracic surgery operations, the expected PPCs in these patients may be different from those expected in other surgical groups. Therefore, the ARISCAT risk index may be insufficient to evaluate PPCs in thoracic surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Keçioören
      • Ankara, Keçioören, Turkey
        • Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18-75 years who are scheduled for elective thoracotomy or VATS, who have not had previous thoracic surgery, and without advanced lung and heart disease.

Description

Inclusion Criteria:

  • Patients who will undergo elective thoracotomy or video assisted thoracic surgery with general anesthesia
  • BMI < 35 kg/m2
  • Age 18 - 75 years old
  • Expected operative time more than 60 minutes

Exclusion Criteria:

  • History of lung surgery
  • Advanced lung-heart disease
  • Having a previous COVID-19 pneumonia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Distribution of patients who developed one or more postoperative pulmonary complications according to preoperative neutrophil/lymphocyte ratio, albumin value, ARISCAT risk index, nutritional risk score, and ASA physical status.
Time Frame: Time to preoperative visit and through study completion, an average of three months.

  1. Effectiveness of the ARISCAT risk scoring index [ Time Frame: postoperative first 30 days ]

    to investigate the effectiveness of the ARISCAT risk scoring index in predicting the development of PPC in patients undergoing thoracic surgery.

  2. Correlation between ASA physical status (1-3) and PPC [ Time Frame: postoperative first 30 days ]
  3. Correlation between NRS ( nutritional risk score) score (0-3) and PPC [ Time Frame: postoperative first 30 days ]
  4. Correlation between preoperative albumin values (gram / dl) and PPC [ Time Frame: postoperative first 30 days ]
  5. Correlation between preoperative neutrophil/lymphocyte ratio and PPC [ Time Frame: postoperative first 30 days ]
Time to preoperative visit and through study completion, an average of three months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distribution of patients who developed one or more postoperative pulmonary complications according to age, gender, BMI and preoperative SpO2 level.
Time Frame: Time to preoperative visit and up to 30 days.
  1. Correlation between age (years) and PPC [ Time Frame: postoperative first 30 days
  2. Correlation between gender(male or female) and PPC [ Time Frame: postoperative first 30 days ]
  3. Correlation between BMI (kg/m^2) and PPC [ Time Frame: postoperative first 30 days ]
  4. Correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC [ Time Frame: postoperative first 30 days ]
Time to preoperative visit and up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-KAEK-15/2230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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