Protective intraoperative ventilation with higher versus lower levels of positive endexpiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

Creative Commons License

Yavru H. A., Sivrikoz N., Savran Karadeniz M.

TRIALS, cilt.8, sa.1, ss.202-210, 2017 (SCI-Expanded)

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 8 Sayı: 1
  • Basım Tarihi: 2017
  • Dergi Adı: TRIALS
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.202-210
  • İstanbul Üniversitesi Adresli: Evet

Özet

Protective intraoperative ventilation with

higher versus lower levels of positive endexpiratory

pressure in obese patients

(PROBESE): study protocol for a randomized

controlled trial

T. Bluth1, R. Teichmann1, T. Kiss1, I. Bobek2, J. Canet3, G. Cinnella4, L. De Baerdemaeker5, C. Gregoretti6,

G. Hedenstierna7, S. N. Hemmes8,9, M. Hiesmayr10,11,12,13, M. W. Hollmann8,9, S. Jaber14, J. G. Laffey15,16,17,18,

M. J. Licker19, K. Markstaller20, I. Matot21, G. Müller22, G. H. Mills23, J. P. Mulier24, C. Putensen25, R. Rossaint26,

J. Schmitt22, M. Senturk27, A. Serpa Neto28,29, P. Severgnini30, J. Sprung31, M. F. Vidal Melo32, H. Wrigge33,

M. J. Schultz9,34, P. Pelosi35, M. Gama de Abreu1* , for the PROBESE investigators, and the PROtective VEntilation

Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)

Abstract

Background: Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in

obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve

intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain.

We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as

compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients.

Methods/design: The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in

OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese

patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at

intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal

volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment

maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will

be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint.

Discussion: To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to

compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on

PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a

certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs.

Trial registration: ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.

Keywords: Mechanical ventilation, Positive end-expiratory pressure, Recruitment maneuver, Obesity, Postoperative