Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response

study protocol for a randomized controlled trial

Zoltán Ruszkai, Erika Kiss, Ildikó László, Fanni Gyura, Erika Surány, Péter Töhötöm Bartha, Gergely Péter Bokrétás, Edit Rácz, István Buzogány, Zoltán Bajory, Erzsébet Hajdú, Z. Molnár

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

BACKGROUND: Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs. Recent studies show benefits of lung-protective mechanical ventilation with the use of low tidal volumes, a moderate level of positive end-expiratory pressure (PEEP) and regular alveolar recruitment maneuvers during general anesthesia, even in patients with healthy lungs. The purpose of this clinical trial is to evaluate the effects of intraoperative lung-protective mechanical ventilation, using individualized PEEP values, on postoperative pulmonary complications and the inflammatory response.

METHODS/DESIGN: A total number of 40 patients with bladder cancer undergoing open radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) will be enrolled and randomized into a study (SG) and a control group (CG). Standard lung-protective ventilation with a PEEP of 6 cmH2O will be applied in the CG and an optimal PEEP value determined during a static pulmonary compliance (Cstat)-directed PEEP titration procedure will be used in the SG. Low tidal volumes (6 mL/Kg ideal bodyweight) and a fraction of inspired oxygen of 0.5 will be applied in both groups. After surgery both groups will receive standard postoperative management. Primary endpoints are postoperative pulmonary complications and serum procalcitonin kinetics during and after surgery until the third postoperative day. Secondary and tertiary endpoints will be: organ dysfunction as monitored by the Sequential Organ Failure Assessment Score, in-hospital stay, 28-day and in-hospital mortality.

DISCUSSION: This trial will assess the possible benefits or disadvantages of an individualized lung-protective mechanical ventilation strategy during open radical cystectomy and urinary diversion regarding postoperative pulmonary complications and the inflammatory response.

TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02931409 . Registered on 5 October 2016.

Original languageEnglish
Number of pages1
JournalTrials
Volume18
Issue number1
DOIs
Publication statusPublished - Aug 11 2017

Fingerprint

Positive-Pressure Respiration
Randomized Controlled Trials
Lung
Artificial Respiration
Urinary Diversion
Cystectomy
Tidal Volume
General Anesthesia
Organ Dysfunction Scores
Lung Compliance
Control Groups
Pulmonary Atelectasis
Calcitonin
Hospital Mortality
Urinary Bladder Neoplasms
Ventilation
Length of Stay
Urinary Bladder
Clinical Trials
Oxygen

Keywords

  • Lung-protective ventilation
  • Positive end-expiratory pressure
  • Postoperative pulmonary complications
  • Procalcitonin
  • Radical cystectomy
  • Static pulmonary compliance

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response : study protocol for a randomized controlled trial. / Ruszkai, Zoltán; Kiss, Erika; László, Ildikó; Gyura, Fanni; Surány, Erika; Bartha, Péter Töhötöm; Bokrétás, Gergely Péter; Rácz, Edit; Buzogány, István; Bajory, Zoltán; Hajdú, Erzsébet; Molnár, Z.

In: Trials, Vol. 18, No. 1, 11.08.2017.

Research output: Contribution to journalArticle

Ruszkai, Z, Kiss, E, László, I, Gyura, F, Surány, E, Bartha, PT, Bokrétás, GP, Rácz, E, Buzogány, I, Bajory, Z, Hajdú, E & Molnár, Z 2017, 'Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response: study protocol for a randomized controlled trial', Trials, vol. 18, no. 1. https://doi.org/10.1186/s13063-017-2116-z
Ruszkai, Zoltán ; Kiss, Erika ; László, Ildikó ; Gyura, Fanni ; Surány, Erika ; Bartha, Péter Töhötöm ; Bokrétás, Gergely Péter ; Rácz, Edit ; Buzogány, István ; Bajory, Zoltán ; Hajdú, Erzsébet ; Molnár, Z. / Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response : study protocol for a randomized controlled trial. In: Trials. 2017 ; Vol. 18, No. 1.
@article{1b1bbf4ab7eb4b6aa0718e8fbd905cdd,
title = "Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response: study protocol for a randomized controlled trial",
abstract = "BACKGROUND: Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs. Recent studies show benefits of lung-protective mechanical ventilation with the use of low tidal volumes, a moderate level of positive end-expiratory pressure (PEEP) and regular alveolar recruitment maneuvers during general anesthesia, even in patients with healthy lungs. The purpose of this clinical trial is to evaluate the effects of intraoperative lung-protective mechanical ventilation, using individualized PEEP values, on postoperative pulmonary complications and the inflammatory response.METHODS/DESIGN: A total number of 40 patients with bladder cancer undergoing open radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) will be enrolled and randomized into a study (SG) and a control group (CG). Standard lung-protective ventilation with a PEEP of 6 cmH2O will be applied in the CG and an optimal PEEP value determined during a static pulmonary compliance (Cstat)-directed PEEP titration procedure will be used in the SG. Low tidal volumes (6 mL/Kg ideal bodyweight) and a fraction of inspired oxygen of 0.5 will be applied in both groups. After surgery both groups will receive standard postoperative management. Primary endpoints are postoperative pulmonary complications and serum procalcitonin kinetics during and after surgery until the third postoperative day. Secondary and tertiary endpoints will be: organ dysfunction as monitored by the Sequential Organ Failure Assessment Score, in-hospital stay, 28-day and in-hospital mortality.DISCUSSION: This trial will assess the possible benefits or disadvantages of an individualized lung-protective mechanical ventilation strategy during open radical cystectomy and urinary diversion regarding postoperative pulmonary complications and the inflammatory response.TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02931409 . Registered on 5 October 2016.",
keywords = "Lung-protective ventilation, Positive end-expiratory pressure, Postoperative pulmonary complications, Procalcitonin, Radical cystectomy, Static pulmonary compliance",
author = "Zolt{\'a}n Ruszkai and Erika Kiss and Ildik{\'o} L{\'a}szl{\'o} and Fanni Gyura and Erika Sur{\'a}ny and Bartha, {P{\'e}ter T{\"o}h{\"o}t{\"o}m} and Bokr{\'e}t{\'a}s, {Gergely P{\'e}ter} and Edit R{\'a}cz and Istv{\'a}n Buzog{\'a}ny and Zolt{\'a}n Bajory and Erzs{\'e}bet Hajd{\'u} and Z. Moln{\'a}r",
year = "2017",
month = "8",
day = "11",
doi = "10.1186/s13063-017-2116-z",
language = "English",
volume = "18",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response

T2 - study protocol for a randomized controlled trial

AU - Ruszkai, Zoltán

AU - Kiss, Erika

AU - László, Ildikó

AU - Gyura, Fanni

AU - Surány, Erika

AU - Bartha, Péter Töhötöm

AU - Bokrétás, Gergely Péter

AU - Rácz, Edit

AU - Buzogány, István

AU - Bajory, Zoltán

AU - Hajdú, Erzsébet

AU - Molnár, Z.

PY - 2017/8/11

Y1 - 2017/8/11

N2 - BACKGROUND: Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs. Recent studies show benefits of lung-protective mechanical ventilation with the use of low tidal volumes, a moderate level of positive end-expiratory pressure (PEEP) and regular alveolar recruitment maneuvers during general anesthesia, even in patients with healthy lungs. The purpose of this clinical trial is to evaluate the effects of intraoperative lung-protective mechanical ventilation, using individualized PEEP values, on postoperative pulmonary complications and the inflammatory response.METHODS/DESIGN: A total number of 40 patients with bladder cancer undergoing open radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) will be enrolled and randomized into a study (SG) and a control group (CG). Standard lung-protective ventilation with a PEEP of 6 cmH2O will be applied in the CG and an optimal PEEP value determined during a static pulmonary compliance (Cstat)-directed PEEP titration procedure will be used in the SG. Low tidal volumes (6 mL/Kg ideal bodyweight) and a fraction of inspired oxygen of 0.5 will be applied in both groups. After surgery both groups will receive standard postoperative management. Primary endpoints are postoperative pulmonary complications and serum procalcitonin kinetics during and after surgery until the third postoperative day. Secondary and tertiary endpoints will be: organ dysfunction as monitored by the Sequential Organ Failure Assessment Score, in-hospital stay, 28-day and in-hospital mortality.DISCUSSION: This trial will assess the possible benefits or disadvantages of an individualized lung-protective mechanical ventilation strategy during open radical cystectomy and urinary diversion regarding postoperative pulmonary complications and the inflammatory response.TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02931409 . Registered on 5 October 2016.

AB - BACKGROUND: Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs. Recent studies show benefits of lung-protective mechanical ventilation with the use of low tidal volumes, a moderate level of positive end-expiratory pressure (PEEP) and regular alveolar recruitment maneuvers during general anesthesia, even in patients with healthy lungs. The purpose of this clinical trial is to evaluate the effects of intraoperative lung-protective mechanical ventilation, using individualized PEEP values, on postoperative pulmonary complications and the inflammatory response.METHODS/DESIGN: A total number of 40 patients with bladder cancer undergoing open radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) will be enrolled and randomized into a study (SG) and a control group (CG). Standard lung-protective ventilation with a PEEP of 6 cmH2O will be applied in the CG and an optimal PEEP value determined during a static pulmonary compliance (Cstat)-directed PEEP titration procedure will be used in the SG. Low tidal volumes (6 mL/Kg ideal bodyweight) and a fraction of inspired oxygen of 0.5 will be applied in both groups. After surgery both groups will receive standard postoperative management. Primary endpoints are postoperative pulmonary complications and serum procalcitonin kinetics during and after surgery until the third postoperative day. Secondary and tertiary endpoints will be: organ dysfunction as monitored by the Sequential Organ Failure Assessment Score, in-hospital stay, 28-day and in-hospital mortality.DISCUSSION: This trial will assess the possible benefits or disadvantages of an individualized lung-protective mechanical ventilation strategy during open radical cystectomy and urinary diversion regarding postoperative pulmonary complications and the inflammatory response.TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02931409 . Registered on 5 October 2016.

KW - Lung-protective ventilation

KW - Positive end-expiratory pressure

KW - Postoperative pulmonary complications

KW - Procalcitonin

KW - Radical cystectomy

KW - Static pulmonary compliance

UR - http://www.scopus.com/inward/record.url?scp=85046476033&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85046476033&partnerID=8YFLogxK

U2 - 10.1186/s13063-017-2116-z

DO - 10.1186/s13063-017-2116-z

M3 - Article

VL - 18

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -