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

NCT04995939 | Completed

• 1 other identifier: 2012-KAEK-15/2230
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative/Postoperative Complications

Outcome Measures

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.

  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 Outcomes (1)

• Distribution of patients who developed one or more postoperative pulmonary complications according to age, gender, BMI and preoperative SpO2 level.

  Time to preoperative visit and up to 30 days.

Interventions

Laboratory parameters and Scoring systems PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Ankara, Keçioören, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35905198 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 9, 2021
• Study Start: March 15, 2021
• Primary Completion: August 15, 2021
• Study Completion: November 15, 2021
• Last Updated: February 16, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)