Postoperative ComplicationsNCT06415253
Comparison of ARISCAT Score and Post-operative Pulmonary Complication Rate in Percutaneous Nephrolithotomy
An observational study of Postoperative Complications and Nephrolithotomy, Percutaneous, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Complications, Nephrolithotomy, Percutaneous
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- American Society of Anesthesiologists (ASA) I-III patients
- Patients who undergone of Percutaneous Nephrolithotomy procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital
Sanliurfa, 63050
About this study
Official title: Comparison of ARISCAT Score and Post-operative Pulmonary Complication Rate in Percutaneous Nephrolithotomy Cases: The Effect of Prone Position and Endoscopic Intervention
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.
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who had undergone Percutaneous Nephrolithotomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of pulmonary complication
rate of pulmonary complication such as respiratory failure, bronchospasm, atelectasis, pneumothorax, pleural effusion, or aspiration pneumonia.
Measured: The postoperative period in the first 24 hours
rate of lung infection
rate of pneumonia (bacterial or virutic)
Measured: The postoperative period in the first 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start31 Aug 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmet kaya, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415253
- Sponsor's protocol ID
- MAIEAH630003
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ARISCAT Score and Post-operative Pulmonary Complication Rate in Percutaneous Nephrolithotomy Cases: The Effect of Prone Position and Endoscopic Intervention
- ClinicalTrials.gov ID
- NCT06415253
- Acronym / sponsor ID
- MAIEAH630003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who had undergone Percutaneous Nephrolithotomy | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) I-III patients
- Patients who undergone of Percutaneous Nephrolithotomy procedure
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of pulmonary complication
Time frame: The postoperative period in the first 24 hours
rate of pulmonary complication such as respiratory failure, bronchospasm, atelectasis, pneumothorax, pleural effusion, or aspiration pneumonia.
rate of lung infection
Time frame: The postoperative period in the first 72 hours
rate of pneumonia (bacterial or virutic)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Nephrolithotomy, Percutaneous, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of pulmonary complication (time frame: The postoperative period in the first 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.