NCT06462976

Brief Summary

The aim of this study is to investigate the effect of different surgical positions (supine/prone) on lung mechanical power (MP) and its relationship with postoperative pulmonary complications in patients planned to percutaneous nephrolithotomy (PNL) under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

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

First Submitted

Initial submission to the registry

June 4, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

May 6, 2026

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

June 4, 2024

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • mechanical power

    mechanical power=0.098\*minute ventilation \*(Ppeak-0.5\*(Pplato-PEEP)

    2 year

Study Arms (2)

supine

Which group the patients will be included in will be determined by the surgical team based on the location and number of stones. The patient's values will be recorded in that position.

Other: mechanical power calculation

prone

Which group the patients will be included in will be determined by the surgical team based on the location and number of stones. The patient's values will be recorded in that position.

Other: mechanical power calculation

Interventions

Mechanical Power= 0.098×Minute ventilation× (peak pressure - 0.5 (plato pressure-PEEP)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation

pronesupine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are aged 18-75 agree to participate in the study

You may qualify if:

  • Patients who will undergo elective percutaneous nephrolithotomy and agree to participate in the study.
  • ASA 1-3 patient

You may not qualify if:

  • Patients with acute and chronic hypoxemia (PaO2\<65mmHg, SpO2\<95 in room air)
  • Patients with BMI\>35
  • Patients with obstructive sleep apnea syndrome
  • Patients with ASA 4 and above
  • Pregnant patients
  • Pneumonia, COPD attack etc. before the operation. people with lung disease
  • Unstable patients such as uncontrolled hypertension, decompensated heart
  • Mentally retarded and uncooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gamze Talih

Kayseri, Kayseri, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 17, 2024

Study Start

July 1, 2025

Primary Completion

January 31, 2026

Study Completion

April 15, 2026

Last Updated

May 6, 2026

Record last verified: 2025-06

Locations