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Topp luftveistrykk og respirasjonsmekanikk under PRVC-ventilering ved laparoskopisk kirurgi

30. oktober 2026 oppdatert av: Specialized Medical Center (SMC)

Peak Airway Pressure and Respiratory Mechanics During Pressure-Regulated Volume Control Ventilation in Patients Undergoing Laparoscopic Abdominal Surgery: A Prospective Observational Study

This study aims to evaluate peak airway pressure and respiratory mechanics during pressure-regulated volume control (PRVC) ventilation in patients undergoing elective laparoscopic abdominal surgery. Pneumoperitoneum and patient positioning during laparoscopic procedures can significantly affect respiratory mechanics, including airway pressures and lung compliance.

The study will assess changes in peak airway pressure, dynamic compliance, and other ventilatory parameters during different intraoperative phases. The findings are expected to provide insights into optimizing ventilatory strategies to improve patient safety and minimize ventilator-associated complications during laparoscopic surgery.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Laparoscopic abdominal surgery requires the creation of pneumoperitoneum, which increases intra-abdominal pressure and affects respiratory system mechanics. These changes can lead to increased peak airway pressure and reduced lung compliance, potentially increasing the risk of ventilator-induced lung injury.

Pressure-regulated volume control (PRVC) ventilation is designed to deliver a set tidal volume with the lowest possible airway pressure by adjusting inspiratory pressure dynamically. However, its performance during laparoscopic procedures and its effect on respiratory mechanics require further evaluation.

This prospective observational study will be conducted on adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Standardized anesthesia and ventilation protocols will be applied. Respiratory parameters including peak airway pressure, plateau pressure, tidal volume, respiratory rate, and dynamic compliance will be recorded at three predefined stages, each after a minimum 5-minute stabilization interval: after induction and intubation (supine, before pneumoperitoneum), after establishment of pneumoperitoneum, and after final surgical positioning.

The primary outcome will be the change in peak airway pressure across the three stages. Secondary outcomes include dynamic compliance and other ventilatory and hemodynamic parameters. The study aims to enhance understanding of respiratory mechanics during PRVC ventilation and support evidence-based optimization of intraoperative ventilation strategies.

Studietype

Observasjonsmessig

Registrering (Faktiske)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Saudi-Arabia
      • Riyadh, Saudi-Arabia
        • SpecializedMedicalCenter

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

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.

Beskrivelse

Inclusion Criteria:

  • Adult patients aged 18-65 years
  • Scheduled for elective laparoscopic abdominal surgery under general anesthesia
  • ASA physical status I-II
  • Patients requiring mechanical ventilation using PRVC mode
  • Provided informed consent

Exclusion Criteria:

  • Patients with significant cardiopulmonary disease
  • Chronic obstructive pulmonary disease or restrictive lung disease
  • Morbid obesity (BMI > 35 kg/m²)
  • Pregnancy
  • Emergency surgeries
  • Patients with anticipated difficult airway
  • Refusal to participate

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Single Cohort

Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia with pressure-regulated volume control (PRVC) ventilation. Respiratory parameters are recorded at predefined intraoperative time points.
Annen: PRVC Ventilation

Mechanical ventilation using pressure-regulated volume control mode applied as part of routine intraoperative anesthesia care. No experimental intervention is introduced.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peak Airway Pressure
Tidsramme: At 0, 5, and 10 minutes intraoperatively

Peak airway pressure (PIP) measured intraoperatively using the anesthesia workstation under standardized pressure-regulated volume control ventilation settings.
At 0, 5, and 10 minutes intraoperatively

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dynamic Compliance
Tidsramme: At 0, 5, and 10 minutes intraoperatively

Dynamic lung compliance (Cdyn) measured intraoperatively using standard anesthesia monitoring at predefined time points.
At 0, 5, and 10 minutes intraoperatively
Plateau Pressure
Tidsramme: At 0, 5, and 10 minutes intraoperatively

Plateau pressure (Pplat) measured during controlled ventilation using the anesthesia workstation.
At 0, 5, and 10 minutes intraoperatively
End-tidal Carbon Dioxide
Tidsramme: At 0, 5, and 10 minutes intraoperatively

End-tidal carbon dioxide (EtCO2) measured continuously during mechanical ventilation.
At 0, 5, and 10 minutes intraoperatively
Mean Airway Pressure
Tidsramme: At 0, 5, and 10 minutes intraoperatively

Mean airway pressure measured intraoperatively using the anesthesia workstation.
At 0, 5, and 10 minutes intraoperatively
Oxygen Saturation
Tidsramme: At 0, 5, and 10 minutes intraoperatively

Peripheral oxygen saturation (SpO2) monitored continuously during surgery.
At 0, 5, and 10 minutes intraoperatively
Heart Rate (beats/min)
Tidsramme: At 0, 5, and 10 minutes intraoperatively

Heart rate measured intraoperatively using standard monitoring
At 0, 5, and 10 minutes intraoperatively
Mean Arterial Pressure (mmHg)
Tidsramme: At 0, 5, and 10 minutes intraoperatively

Mean arterial pressure measured intraoperatively using standard monitoring
At 0, 5, and 10 minutes intraoperatively
Minute Ventilation
Tidsramme: At 0, 5, and 10 minutes intraoperatively

Minute ventilation recorded from the anesthesia workstation during controlled ventilation.
At 0, 5, and 10 minutes intraoperatively

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Specialized Medical Center (SMC)

Etterforskere

  • Hovedetterforsker: Salaheldin A Abdelaziz Ahmed, MD, Specialized Medical Center (SMC), Riyadh, Saudi Arabia

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)

8. august 2026

Primær fullføring (Faktiske)

29. oktober 2026

Studiet fullført (Faktiske)

29. oktober 2026

Datoer for studieregistrering

Først innsendt

13. april 2026

Først innsendt som oppfylte QC-kriteriene

18. april 2026

Først lagt ut (Faktiske)

22. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • IRB-002-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No, individual participant data (IPD) will not be shared.

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. .

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