Clinical trial NCT04995939: Preoperative Laboratory Parameters and Scorings Systems on Postoperative Pulmonary Complications in Thoracic Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative/Postoperative Complications
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Time to preoperative visit and through study completion, an average of three months.
Secondary outcomes:
measure: Distribution of patients who developed one or more postoperative pulmonary complications according to age, gender, BMI and preoperative SpO2 level.
timeFrame: Time to preoperative visit and up to 30 days.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
state: Keçioören
Study officials:
References:
citation: Ulger G, Sazak H, Baldemir R, Zengin M, Kaybal O, Incekara F, Alagoz A. The effectiveness of ARISCAT Risk Index, other scoring systems, and parameters in predicting pulmonary complications after thoracic surgery. Medicine (Baltimore). 2022 Jul 29;101(30):e29723. doi: 10.1097/MD.0000000000029723.