NCT06415253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

May 10, 2024

Last Update Submit

May 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • rate of pulmonary complication

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

    The postoperative period in the first 24 hours

  • rate of lung infection

    rate of pneumonia (bacterial or virutic)

    The postoperative period in the first 72 hours

Study Arms (1)

Patients who had undergone Percutaneous Nephrolithotomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Sanliurfa, 63050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 16, 2024

Study Start

August 31, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations