## Protocol Section
### Identification Module
**NCT ID:** NCT06415253

**Brief Title:** Comparison of ARISCAT Score and Post-operative Pulmonary Complication Rate in Percutaneous Nephrolithotomy

**Official Title:** Comparison of ARISCAT Score and Post-operative Pulmonary Complication Rate in Percutaneous Nephrolithotomy Cases: The Effect of Prone Position and Endoscopic Intervention

#### Organization Study ID Info
**ID:** MAIEAH630003
#### Organization
**Class:** OTHER
**Full Name:** Sanliurfa Mehmet Akif Inan Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-08-31

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sanliurfa Mehmet Akif Inan Education and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Sanliurfa Mehmet Akif Inan Education and Research Hospital

**Investigator Full Name:** ahmet kaya

**Investigator Title:** assistant professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Postoperative pulmonary complications are relatively common in all age groups and are closely related to increased costs, morbidity and mortality in the postoperative period. In recent years, various risk indices have been developed for preoperative evaluation to predict postoperative pulmonary complications, such as the American Society of Anaesthesiologists Physical Status Classification (ASA), the Assessment of Respiratory Risk in Surgical Patients in Catalonia (ARISCAT). The ARISCAT score has demonstrated promising results in identifying patients at higher risk for pulmonary complications. The ARISCAT risk index is derived from multiple variables, including age, oxygen saturation, previous respiratory tract infections, anaemia, abdominal or thoracic surgery, operative time, and emergency surgery. The ARISCAT risk index is used to predict respiratory failure, bronchospasm, respiratory tract infections, atelectasis, pneumothorax, pleural effusion, and aspiration pneumonia.

Percutaneous nephrolithotomy (PNL) is a type of operation performed endoscopically in a prone position in cases of kidney stones that cannot be broken by extracorporeal shockwave lithotripsy (ESWL) and/or cannot be removed by ureterocystoscopy. The prone position is one of the positions that limits lung capacity and respiratory function. The objective of this study was to assess the relationship between the ARISCAT score in patients undergoing PNL and the occurrence of pulmonary complications in the postoperative period.

### Conditions Module

**Conditions:**

- Postoperative Complications

- Nephrolithotomy, Percutaneous

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** Patients who had undergone Percutaneous Nephrolithotomy

### Outcomes Module

#### Primary Outcomes

**Description:** rate of pulmonary complication such as respiratory failure, bronchospasm, atelectasis, pneumothorax, pleural effusion, or aspiration pneumonia.

**Measure:** rate of pulmonary complication

**Time Frame:** The postoperative period in the first 24 hours

**Description:** rate of pneumonia (bacterial or virutic)

**Measure:** rate of lung infection

**Time Frame:** The postoperative period in the first 72 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-III patients
* Patients who undergone of Percutaneous Nephrolithotomy procedure

Exclusion Criteria:

* Patients with any liver and/or kidney failure
* Obese patients (body mass index (BMI) 30 and above)
* Trauma patients
* Cancer patients
* American Society of Anesthesiologists (ASA) IV patients
* Cardiac arrhythmia, implanted pacemakers
* A history of chronic pain

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The study included 50 ASA I-III patients aged between 18 and 80 years who were about to undergo percutaneous nephrolithotomy.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Şanlıurfa

**Country:** Turkey

**Facility:** University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital

**Zip:** 63050

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14065

- Name: Postoperative Complications

- Relevance: HIGH

- As Found: Postoperative Complications

### Condition Browse Module - Meshes

- ID: D000011183

- Term: Postoperative Complications

### Misc Info Module

- Version Holder: 2024-05-31
