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Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery (Inprove4large)

16. mai 2019 oppdatert av: Massimo Antonelli, Catholic University of the Sacred Heart

Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery. A Single-centre Randomized, Controlled Trial

Background. The use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. It is unknown whether such ventilatory approach may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and Trendelenburg position may alter lung volumes and chest-wall elastance.

Objective. The investigators designed a randomized, controlled trial to assess the effect of a lung-protective ventilation strategy on postoperative oxygenation in obese patients undergoing laparoscopic surgery.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Italia
      • Rome, Italia, 00100
        • General surgery OR, A. Gemelli hospital

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • scheduled for gynaecological laparoscopic surgery in the Trendelenburg position
  • Obesity with body mass index>35 kg/m^2
  • written informed consent

Exclusion Criteria:

  • Clinical history or signs of chronic heart failure
  • history of neuromuscular disease
  • history of thoracic surgery
  • pregnancy
  • chronic respiratory failure requiring long-term oxygen administration

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Protective ventilation
Volume controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight (45.5 + 0.91 (height [cm] -152.4)), FiO2 0.4 and PEEP 10 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8 seconds and an inspiratory pause of 0.3 seconds and FiO2 will be kept unchanged during the whole study period. In patients in this group, recruiting maneuvers will be performed throughout a stepwise 5 cmH2O PEEP increase every 30 seconds to achieve a PEEP of 35 cmH2O during Pressure Controlled Ventilation (10 cmH2O of inspiratory pressure while keeping respiratory rate unmodified), followed by a stepwise 5 cmH2O PEEP reduction every 30 seconds until the baseline set peep is reached.
Legemiddel: Intravenous anesthetic
Anaesthesia induction will be obtained with i.v. 2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium. Anaesthesia will be maintained with i.v. propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50
Legemiddel: Crystalloid Solutions
Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h. Treatment of eventual hemodynamic instability will be left to the attending physician
Diagnostisk test: Esophageal pressure measurement
A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure
Diagnostisk test: Lung volume measurement with the nitrogen washin-washout technique
Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.
Aktiv komparator: Standard Ventilation
Volume controlled ventilation with tidal volume 10 ml/kg of PBW (45.5 + 0.91 (height [cm] -152.4)), FiO2 0.4 and PEEP 5 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 mmHg and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8-1 seconds and an inspiratory pause of 0.3 second
Legemiddel: Intravenous anesthetic
Anaesthesia induction will be obtained with i.v. 2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium. Anaesthesia will be maintained with i.v. propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50
Legemiddel: Crystalloid Solutions
Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h. Treatment of eventual hemodynamic instability will be left to the attending physician
Diagnostisk test: Esophageal pressure measurement
A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure
Diagnostisk test: Lung volume measurement with the nitrogen washin-washout technique
Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative oxygenation
Tidsramme: One hour after extubation
PaO2/FiO2 ratio 1 hour after extubation, while the patient is receiving oxygen through VenturiMask 40%
One hour after extubation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative forced expiratory volume in 1 second (FEV1)
Tidsramme: 48 hours after the end of surgery
volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity
48 hours after the end of surgery
Postoperative forced vital capacity (FVC)
Tidsramme: 48 hours after the end of surgery
the total amount of air exhaled during a forced expiratory maneuver started from the level of total lung capacity
48 hours after the end of surgery
Postoperative Tiffeneau index
Tidsramme: 48 hours after the end of surgery
computed as FEV1/FVC
48 hours after the end of surgery
Postoperative Dyspnea
Tidsramme: 1 hour after surgery
Dyspnea assessed by Borg dyspnea scale
1 hour after surgery
Pulmonary infection
Tidsramme: 24 hours after the end of surgery
modified clinical pulmonary infection score (mCPIS)
24 hours after the end of surgery
Postoperative pulmonary infiltrates
Tidsramme: 24 hours after the end of surgery
Evaluated with the chest x-ray by two independent clinicians blinded to treatment assignment
24 hours after the end of surgery
Intraoperative driving pressure
Tidsramme: during surgery, recorded on a 60-minute basis
driving pressure, computed as Plateau pressure-PEEP
during surgery, recorded on a 60-minute basis
Intraoperative lung driving pressure
Tidsramme: during surgery, recorded on a 60-minute basis
transpulmonary driving pressure, computed as Transpulmonary end-inspiratory pressure-transpulmonary total end-expiratory pressure
during surgery, recorded on a 60-minute basis
Intraoperative oxygenation
Tidsramme: during surgery, recorded on a 60-minute basis
PaO2/FiO2
during surgery, recorded on a 60-minute basis
Intraoperative dead space
Tidsramme: during surgery, recorded on a 60-minute basis
Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2
during surgery, recorded on a 60-minute basis
Lung recruitment
Tidsramme: during surgery, recorded on a 60-minute basis
lung recruitment/changes in end expiratory lung volume between the two groups
during surgery, recorded on a 60-minute basis
Intraoperative blood pressure
Tidsramme: during surgery, recorded on a 60-minute basis
Arterial blood pressure
during surgery, recorded on a 60-minute basis
Intraoperative respiratory system compliance
Tidsramme: during surgery, recorded on a 60-minute basis
computed as Tidal volume/airway driving pressure
during surgery, recorded on a 60-minute basis
Intraoperative lung compliance
Tidsramme: during surgery, recorded on a 60-minute basis
computed as Tidal volume/lung driving pressure
during surgery, recorded on a 60-minute basis

Samarbeidspartnere og etterforskere

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

Sponsor

Catholic University of the Sacred Heart

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. mai 2017

Primær fullføring (Faktiske)

31. mars 2019

Studiet fullført (Faktiske)

31. mars 2019

Datoer for studieregistrering

Først innsendt

12. mai 2017

Først innsendt som oppfylte QC-kriteriene

15. mai 2017

Først lagt ut (Faktiske)

17. mai 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • InproveForLarge

Plan for individuelle deltakerdata (IPD)

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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