BACKGROUND: Benefits and limitations of supplementation with 80% fraction of inspired oxygen for preventing surgical site infections have not yet been clearly defined. Some studies have reported benefits in colorectal surgery, whereas trials in abdominal and gynecologic surgery have reported either no effect or a deleterious effect. METHODS: Controlled, randomized, assessor-blind multicenter trial, the ISO2 study, comparing the effects of hyperoxygenation (fraction of inspired oxygen, 80%) with those of 30% oxygen on the frequency of surgical site infections in routine abdominal, gynecologic, and breast surgery on 434 patients. Patients not seen in consultation after discharge were contacted. RESULTS: In total, 208 patients received 30% perioperative oxygen and 226 received 80%. There was no difference between the two groups for baseline, intraoperative, and postoperative characteristics, except for oxygen saturation at closure, higher in the 80% group (P=0.01). The frequency of 30-day surgical site infections was 7.2% (15/208) in the 30% group and 6.6% (15/226) in the 80% group (relative risk, 0.92; 95% CI [0.46-1.84], P=0.81). Frequency of adverse events (nausea and vomiting, sternal pain, cough, hypotension) was similar in the two groups. Desaturation and bradycardia were more frequent in the 30% group. In an updated meta-analysis including the result of this trial and those of eight published randomized trials, the overall relative risk was 0.97; 95% CI (0.68-1.40), I2 (inconsistency degree)=73%, (P=0.88). CONCLUSIONS: The routine use of hyperoxygenation throughout abdominal, gynecologic, and breast surgery had no effect on the frequency of 30-day surgical site infections and was not accompanied by more frequent adverse effects.
RCT Entities:
BACKGROUND: Benefits and limitations of supplementation with 80% fraction of inspired oxygen for preventing surgical site infections have not yet been clearly defined. Some studies have reported benefits in colorectal surgery, whereas trials in abdominal and gynecologic surgery have reported either no effect or a deleterious effect. METHODS: Controlled, randomized, assessor-blind multicenter trial, the ISO2 study, comparing the effects of hyperoxygenation (fraction of inspired oxygen, 80%) with those of 30% oxygen on the frequency of surgical site infections in routine abdominal, gynecologic, and breast surgery on 434 patients. Patients not seen in consultation after discharge were contacted. RESULTS: In total, 208 patients received 30% perioperative oxygen and 226 received 80%. There was no difference between the two groups for baseline, intraoperative, and postoperative characteristics, except for oxygen saturation at closure, higher in the 80% group (P=0.01). The frequency of 30-day surgical site infections was 7.2% (15/208) in the 30% group and 6.6% (15/226) in the 80% group (relative risk, 0.92; 95% CI [0.46-1.84], P=0.81). Frequency of adverse events (nausea and vomiting, sternal pain, cough, hypotension) was similar in the two groups. Desaturation and bradycardia were more frequent in the 30% group. In an updated meta-analysis including the result of this trial and those of eight published randomized trials, the overall relative risk was 0.97; 95% CI (0.68-1.40), I2 (inconsistency degree)=73%, (P=0.88). CONCLUSIONS: The routine use of hyperoxygenation throughout abdominal, gynecologic, and breast surgery had no effect on the frequency of 30-day surgical site infections and was not accompanied by more frequent adverse effects.
Authors: Jørn Wetterslev; Christian S Meyhoff; Lars N Jørgensen; Christian Gluud; Jane Lindschou; Lars S Rasmussen Journal: Cochrane Database Syst Rev Date: 2015-06-25
Authors: Johanne M Holst; Maibritt P Klitholm; Jeppe Henriksen; Mikael F Vallentin; Marie K Jessen; Maria Bolther; Mathias J Holmberg; Maria Høybye; Peter Carøe Lind; Asger Granfeldt; Lars W Andersen Journal: Acta Anaesthesiol Scand Date: 2022-08-22 Impact factor: 2.274
Authors: Maria Høybye; Peter C Lind; Mathias J Holmberg; Maria Bolther; Marie K Jessen; Mikael F Vallentin; Frederik B Hansen; Johanne M Holst; Andreas Magnussen; Niklas S Hansen; Cecilie M Johannsen; Johannes Enevoldsen; Thomas H Jensen; Lara L Roessler; Maibritt P Klitholm; Mark A Eggertsen; Philip Caap; Caroline Boye; Karol M Dabrowski; Lasse Vormfenne; Jeppe Henriksen; Mathias Karlsson; Ida R Balleby; Marie S Rasmussen; Kim Paelestik; Asger Granfeldt; Lars W Andersen Journal: Acta Anaesthesiol Scand Date: 2022-06-23 Impact factor: 2.274
Authors: Carlos Ferrando; Marina Soro; Carmen Unzueta; Jaume Canet; Gerardo Tusman; Fernando Suarez-Sipmann; Julian Librero; Salvador Peiró; Natividad Pozo; Carlos Delgado; Maite Ibáñez; César Aldecoa; Ignacio Garutti; David Pestaña; Aurelio Rodríguez; Santiago García Del Valle; Oscar Diaz-Cambronero; Jaume Balust; Francisco Javier Redondo; Manuel De La Matta; Lucía Gallego; Manuel Granell; Pascual Martínez; Ana Pérez; Sonsoles Leal; Kike Alday; Pablo García; Pablo Monedero; Rafael Gonzalez; Guido Mazzinari; Gerardo Aguilar; Jesús Villar; Francisco Javier Belda Journal: BMJ Open Date: 2017-07-31 Impact factor: 2.692