Pneumonia Clinical Trials

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Domain-Specific Appendix: OXYGEN

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or wound infections) and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases days alive and at home up to 30 days after surgery (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patient (≥18 years of age at time of admission)

• Scheduled to undergo a surgical procedure involving a skin incision, with an expected duration of at least 2 hours, and a planned overnight hospital stay of at least 1 night (including, but not limited to, cardiac surgery, orthopedic surgery, obstetric, or gynecological surgery).

Locations
Other Locations
Australia
The Alfred
RECRUITING
Melbourne
New Zealand
Wellington Hospital
RECRUITING
Wellington
Contact Information
Primary
Paul S Myles, DSc
p.myles@alfred.org.au
+6190762000
Backup
Trisha Peel, PhD
trisha.peel@monash.edu
+61 3 9076 5436
Time Frame
Start Date: 2026-04-06
Estimated Completion Date: 2035-12
Participants
Target number of participants: 7800
Treatments
Active_comparator: Liberal inspired oxygen
FiO2 0.8; i.e. 80%
Active_comparator: Conservative inspired oxygen
FiO2 ≤0.3 \[30%\]
Active_comparator: Intermediate inspired oxygen
FiO2 0.5 \[50%\]
Related Therapeutic Areas
Sponsors
Leads: Monash University
Collaborators: The Alfred, Wellington Hospital

This content was sourced from clinicaltrials.gov