Perioperative oxygen administration in patients undergoing major non-cardiac surgery under general anaesthesia in Australia and New Zealand: study protocol for a prospective multi-centre observational study.

PRospective Observational Study of perioperative OXygen administration (PROSOX) in patients undergoing major non-cardiac surgery under general anaesthesia in Australia and New Zealand.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12620001013954

Acronym

PROSOX

Enrollment

150

Registered

2020-10-07

Start date

2021-01-01

Completion date

2021-12-12

Last updated

2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the proposed study is to determine the proportion of patients who are administered oxygen therapy in accordance with the current World Health Organisation (WHO) guidelines by anaesthetists in Australia and New Zealand. The primary outcome of this study will be to determine the proportion of cases where time-weighted average intra and postoperative inspired oxygen concentration (FiO2) was at least 0.8 in accordance with WHO guidelines. We hypothesise that among the population group studied, fewer than 5% of patients will be administer intraoperative oxygen therapy as recommended in the WHO guidelines.

Interventions

Inspired oxygen concentration will be obtained from anaesthesia records from the time of ’knife to skin’ FiO2 at 10 minute intervals for the first 120 minutes, and 30 minute intervals for the remaining intraoperative duration until surgical end time.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

The anaesthesia events of participating anaesthetists will be eligible for inclusion if all of the following inclusion criteria are met: 1. Patient at least 18 years of age, ASA 3 or 4 2. Non-cardiac surgery performed under general anaesthesia 3. Expected surgical duration of at least 120 minutes and an anticipated postoperative in hospital stay of at least one night

Exclusion criteria

The anaesthesia event will be excluded if any of the following exclusion criteria are met: 1. Patient is pregnant or receiving supplemental oxygen immediately prior to surgery 2. Site primary investigator view that there exists an indication for or contraindication to specified intraoperative oxygen therapy, which may include but is not limited to severe COPD, previous bleomycin or cisplatin chemotherapy, surgical procedures with a risk of airway fire, and thoracic surgery 3. A prior anaesthesia event already recruited from the individual anaesthetist providing patient care in this study

Outcome results