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Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial.

Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Simonsen I, Pulawska T, Walker LR, Skovgaard N, Heltø K, Gocht-Jensen P, Carlsson PS, Rask H, Karim S, Carlsen CG, Jensen FS, Rasmussen LS, PROXI Trial Gro - Trials (2008)

Bottom Line: A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension.The secondary outcomes are: atelectasis, pneumonia, respiratory failure, re-operation, mortality, duration of postoperative hospitalization, and admission to intensive care unit.The sample size allows detection of a 33% relative risk reduction in the primary outcome with 80% power.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. meyhoff@rh.dk

ABSTRACT

Background: A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension. Two trials have shown that a high perioperative inspiratory oxygen fraction (FiO(2) = 0.80) significantly reduced risk of surgical site infections after elective colorectal surgery, but a third trial was stopped early because the frequency of surgical site infections was more than doubled in the group receiving FiO(2) = 0.80. It has not been settled if a high inspiratory oxygen fraction increases the risk of pulmonary complications, such as atelectasis, pneumonia and respiratory failure. The aim of our trial is to assess the potential benefits and harms of a high perioperative oxygen fraction in patients undergoing abdominal surgery.

Methods and design: The PROXI-Trial is a randomized, patient- and assessor blinded trial of perioperative supplemental oxygen in 1400 patients undergoing acute or elective laparotomy in 14 Danish hospitals. Patients are randomized to receive either 80% oxygen (FiO(2) = 0.80) or 30% oxygen (FiO(2) = 0.30) during surgery and for the first 2 postoperative hours. The primary outcome is surgical site infection within 14 days. The secondary outcomes are: atelectasis, pneumonia, respiratory failure, re-operation, mortality, duration of postoperative hospitalization, and admission to intensive care unit. The sample size allows detection of a 33% relative risk reduction in the primary outcome with 80% power.

Discussion: This trial assesses benefits and harms of a high inspiratory oxygen fraction, and the trial may be generalizable to a general surgical population undergoing laparotomy.

Trial registration: ClinicalTrials.gov identifier: NCT00364741.

No MeSH data available.


Related in: MedlinePlus

Meta-analysis comparing perioperative inspiratory oxygen fractions of 0.80 and 0.30/0.35 on surgical site infection.
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Figure 1: Meta-analysis comparing perioperative inspiratory oxygen fractions of 0.80 and 0.30/0.35 on surgical site infection.

Mentions: In a random-effects model, the overall pooled effect of an inspiratory oxygen fraction of 0.80 was a reduction of the occurrence of surgical site infections. The relative risk reduction was 19% [95% CI: -68% to 61%], P = 0.57, but a large heterogeneity, I2 = 74%, was also found (Fig. 1). This may primarily be explained by the findings in one trial [15], in which the high oxygen fraction was associated with an increase in the frequency of surgical site infection of 122% [95% CI: 8% to 458%]. In that trial, however, mixtures of oxygen and nitrous oxide were given, the surgical site infections were assessed retrospectively by chart review, and the allocation was not fully concealed.


Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial.

Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Simonsen I, Pulawska T, Walker LR, Skovgaard N, Heltø K, Gocht-Jensen P, Carlsson PS, Rask H, Karim S, Carlsen CG, Jensen FS, Rasmussen LS, PROXI Trial Gro - Trials (2008)

Meta-analysis comparing perioperative inspiratory oxygen fractions of 0.80 and 0.30/0.35 on surgical site infection.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2600782&req=5

Figure 1: Meta-analysis comparing perioperative inspiratory oxygen fractions of 0.80 and 0.30/0.35 on surgical site infection.
Mentions: In a random-effects model, the overall pooled effect of an inspiratory oxygen fraction of 0.80 was a reduction of the occurrence of surgical site infections. The relative risk reduction was 19% [95% CI: -68% to 61%], P = 0.57, but a large heterogeneity, I2 = 74%, was also found (Fig. 1). This may primarily be explained by the findings in one trial [15], in which the high oxygen fraction was associated with an increase in the frequency of surgical site infection of 122% [95% CI: 8% to 458%]. In that trial, however, mixtures of oxygen and nitrous oxide were given, the surgical site infections were assessed retrospectively by chart review, and the allocation was not fully concealed.

Bottom Line: A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension.The secondary outcomes are: atelectasis, pneumonia, respiratory failure, re-operation, mortality, duration of postoperative hospitalization, and admission to intensive care unit.The sample size allows detection of a 33% relative risk reduction in the primary outcome with 80% power.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. meyhoff@rh.dk

ABSTRACT

Background: A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension. Two trials have shown that a high perioperative inspiratory oxygen fraction (FiO(2) = 0.80) significantly reduced risk of surgical site infections after elective colorectal surgery, but a third trial was stopped early because the frequency of surgical site infections was more than doubled in the group receiving FiO(2) = 0.80. It has not been settled if a high inspiratory oxygen fraction increases the risk of pulmonary complications, such as atelectasis, pneumonia and respiratory failure. The aim of our trial is to assess the potential benefits and harms of a high perioperative oxygen fraction in patients undergoing abdominal surgery.

Methods and design: The PROXI-Trial is a randomized, patient- and assessor blinded trial of perioperative supplemental oxygen in 1400 patients undergoing acute or elective laparotomy in 14 Danish hospitals. Patients are randomized to receive either 80% oxygen (FiO(2) = 0.80) or 30% oxygen (FiO(2) = 0.30) during surgery and for the first 2 postoperative hours. The primary outcome is surgical site infection within 14 days. The secondary outcomes are: atelectasis, pneumonia, respiratory failure, re-operation, mortality, duration of postoperative hospitalization, and admission to intensive care unit. The sample size allows detection of a 33% relative risk reduction in the primary outcome with 80% power.

Discussion: This trial assesses benefits and harms of a high inspiratory oxygen fraction, and the trial may be generalizable to a general surgical population undergoing laparotomy.

Trial registration: ClinicalTrials.gov identifier: NCT00364741.

No MeSH data available.


Related in: MedlinePlus