Mechanical Power During Different Ventilation Modes in Laparoscopic Surgery
7. juli 2026 oppdatert av: Arif Timuroğlu, MD, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Comparison of Mechanical Power in Pressure-Regulated Volume Control and Volume-Controlled Ventilation Modes During Laparoscopic Cholecystectomy
This study investigates how different breathing machine (ventilator) settings affect the energy delivered to the lungs during surgery.
Mechanical power is a measure of this energy, and high levels can sometimes lead to lung irritation.
In clinical practice, a mode called Pressure-Regulated Volume Control (PRVC) is often used because it lowers the "peak" pressure in the airways, which is generally thought to be safer.
However, doctors have noticed that even though the peak pressure goes down in PRVC mode, the total mechanical power displayed on the monitor might actually increase compared to the standard Volume-Controlled Ventilation (VCV) mode.
In this study, patients undergoing gallbladder surgery will be monitored using both ventilation modes in a random order.
The researchers will compare the machine-calculated mechanical power for both modes to see if the perceived benefit of lower peak pressure in PRVC actually results in lower overall energy transfer to the lungs.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: arif timuroglu, MD
- Telefonnummer: +905072601980
- E-post: ariftimuroglu@yahoo.com
Studiesteder
-
-
Ankara
-
Yenimahalle, Ankara, Tyrkia (Türkiye), 06370
- Rekruttering
- Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital
-
Ta kontakt med:
- arif timuroglu
- Telefonnummer: 05072601980
- E-post: ariftimuroglu@yahoo.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Patients undergoing elective laparoscopic cholecystectomy surgery.
- Patients between 18 and 75 years of age.
- American Society of Anesthesiologists (ASA) physical status I, II or III.
- Body Mass Index (BMI) between 18.5 and 35 kg/m².
- Voluntary written informed consent for participation.
Exclusion Criteria:
- History of significant chronic obstructive pulmonary disease (COPD) or asthma.
- Previous lung resection or major thoracic surgery.
- Heavy smokers (more than 20 cigarettes per day).
- Presence of spontaneous breathing effort during mechanical ventilation.
- Conversion from laparoscopic surgery to open surgery during the procedure.
- Emergency surgery cases.
- Known pregnancy.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: group A; VCV First, Then PRVC
Following the stabilization of pneumoperitoneum, participants will be ventilated using the Volume-Controlled Ventilation (VCV) mode for 10 minutes.
At the end of this period, respiratory data and mechanical power values will be recorded.
Immediately after, the ventilator will be switched to the Pressure-Regulated Volume Control (PRVC) mode with equivalent settings.
After another 10-minute stabilization period in PRVC mode, a second set of measurements will be recorded.
|
Participants will be ventilated with the traditional Volume-Controlled Ventilation (VCV) mode.
Tidal volume, respiratory rate, PEEP, and I:E ratio will be set according to the study protocol and kept constant during the measurement period.
Participants will be ventilated with the Pressure-Regulated Volume Control (PRVC) mode.
This is a hybrid mode that uses a decelerating flow to deliver the target tidal volume at the lowest possible pressure.
Settings will be identical to the VCV mode for each patient.
|
|
Eksperimentell: group B; PRVC First, Then VCV
Following the stabilization of pneumoperitoneum, participants will be ventilated using the Pressure-Regulated Volume Control (PRVC) mode for 10 minutes.
At the end of this period, respiratory data and mechanical power values will be recorded.
Immediately after, the ventilator will be switched to the Volume-Controlled Ventilation (VCV) mode with equivalent settings.
After another 10-minute stabilization period in VCV mode, a second set of measurements will be recorded.
|
Participants will be ventilated with the traditional Volume-Controlled Ventilation (VCV) mode.
Tidal volume, respiratory rate, PEEP, and I:E ratio will be set according to the study protocol and kept constant during the measurement period.
Participants will be ventilated with the Pressure-Regulated Volume Control (PRVC) mode.
This is a hybrid mode that uses a decelerating flow to deliver the target tidal volume at the lowest possible pressure.
Settings will be identical to the VCV mode for each patient.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Device-Displayed Mechanical Power
Tidsramme: At the end of a 10-minute stabilization period in each ventilation mode (VCV and PRVC).
|
The mechanical power value (expressed in Joules per minute - J/min) is automatically calculated and displayed on the monitor of the Mindray A9 anesthesia machine.
This value represents the total energy delivered by the ventilator to the patient's respiratory system per minute.
The study aims to compare how this machine-calculated value differs between the Volume-Controlled Ventilation (VCV) and Pressure-Regulated Volume Control (PRVC) modes under identical clinical conditions.
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At the end of a 10-minute stabilization period in each ventilation mode (VCV and PRVC).
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2026
Primær fullføring (Antatt)
10. august 2026
Studiet fullført (Antatt)
12. august 2026
Datoer for studieregistrering
Først innsendt
22. juni 2026
Først innsendt som oppfylte QC-kriteriene
22. juni 2026
Først lagt ut (Faktiske)
26. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-06/133
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
The de-identified individual participant data (including study protocol and statistical analysis plan) will be made available upon reasonable request to the corresponding author, following the publication of the study results.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .