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Completed

NCT Number: NCT04995939

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Ankara, Keçioören, Turkey (Türkiye)

Who can participate

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

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

Treatment and study plan

Laboratory parameters and Scoring systems

Procedure

Neutrophil/ Lymphocite ratio, albumin level and scoring systems has been evaluated.

Primary outcomes

  1. 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.

    • 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.

    • Correlation between ASA physical status (1-3) and PPC [ Time Frame: postoperative first 30 days ]
    • Correlation between NRS ( nutritional risk score) score (0-3) and PPC [ Time Frame: postoperative first 30 days ]
    • Correlation between preoperative albumin values (gram / dl) and PPC [ Time Frame: postoperative first 30 days ]
    • Correlation between preoperative neutrophil/lymphocyte ratio and PPC [ Time Frame: postoperative first 30 days ]

Secondary outcomes

  1. 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.

    • Correlation between age (years) and PPC [ Time Frame: postoperative first 30 days
    • Correlation between gender(male or female) and PPC [ Time Frame: postoperative first 30 days ]
    • Correlation between BMI (kg/m^2) and PPC [ Time Frame: postoperative first 30 days ]
    • Correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC [ Time Frame: postoperative first 30 days ]

Sponsors and collaborators

Lead sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2021
Registry last updated
Feb 16, 2022

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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