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

Perioperative/Postoperative Complications Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995939
• Other study ID #: 2012-KAEK-15/2230
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 15, 2021
• Est. primary completion date: August 15, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• Laboratory parameters and Scoring systems
Neutrophil/ Lymphocite ratio, albumin level and scoring systems has been evaluated.

Locations

Country	Name	City	State
Turkey	Atatürk Chest Diseases and Chest Surgery Training and Research Hospital	Ankara	Keçioören

Sponsors (1)

Lead Sponsor	Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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 ]	Time to preoperative visit and through study completion, an average of three months.
Secondary	Distribution of patients who developed one or more postoperative pulmonary complications according to age, gender, BMI and preoperative SpO2 level.	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 ]	Time to preoperative visit and up to 30 days.