Perioperative medicine & outcomes
Perioperative lung expansion and pulmonary outcomes after open abdominal surgery versus usual care in the USA (PRIME-AIR): a multicentre, randomised, controlled, phase 3 trial
Primary result · Mean PPC severityResult — go to the resultMean difference 0.07 95% CI −0.03 to 0.18Authors' conclusion
In patients with a BMI of less than 35 kg/m2 who are at moderate-to-high risk of PPCs and undergoing prolonged major open abdominal surgery, a perioperative lung expansion bundle did not reduce PPC severity compared with usual care provided at US academic hospitals.
Study context
- Population
- Adults scheduled for elective open abdominal surgery ≥2 h, intermediate or high PPC risk (ARISCAT ≥26), BMI <35 kg/m², 17 US academic hospitals751 in modified intention-to-treat (mITT)
- Participants
- 794 adults
- Comparison
- Perioperative lung expansion bundle vs usual care
- Intervention bundlen = 379
- Usual caren = 372reference
- Primary endpoint
- Highest severity (grade 0-4) of a composite of postoperative pulmonary complications (PPCs)
- Follow-up
- Postoperative day 7
Methodological detailsmulticentre, phase 3, masked outcome assessment, stratified by centre, Adherence to bundle components 72-98%
- Multicentre
- Phase 3
- Masked outcome assessment
- Stratified by centre
- Adherence to bundle components 72-98%
Primary result
Mean PPC severity
Mean difference
0.07
95% CI −0.03 to 0.18
P = 0.19
By group
Intervention bundle
1.60
mean · SD 0.94
Usual care
1.53
mean · SD 0.93
As reported in the abstract
Further findings
Most common PPC severity: grade 2 · postoperative day 7
Per-protocol NMB dosing
Per-protocol NMB reversal (among those receiving reversal)
Death (cumulative) · 90 days
Intraoperative PEEP
| Outcome | Intervention bundle | Usual care |
|---|---|---|
| Death (cumulative) · 30 days | <1% | 1% |
| Death · 7 days | <1% | 1% |
- Per-protocol NMB reversal (among those receiving reversal): 375 vs 358 received reversal medication
Safety
Adverse events
Serious adverse events
Serious adverse events
- Occurrence of serious adverse events similar in both groups
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →