Trial Outcomes & Findings for An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study (NCT NCT04108130)

NCT ID: NCT04108130

Last Updated: 2025-10-06

Results Overview

The distribution of the number and severity of accumulated post-operative pulmonary complications (PPCs) between the control and intervention groups during the first 7 days after surgery.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 794 participants
• Primary outcome timeframe: Postoperative Days 0 through 7
• Results posted on: 2025-10-06

Participant Flow

Participant milestones

Measure	Usual Care Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention This arm will receive the bundle of perioperative interventions.
Overall Study STARTED	396	398
Overall Study COMPLETED	372	379
Overall Study NOT COMPLETED	24	19

Reasons for withdrawal

Measure	Usual Care Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention This arm will receive the bundle of perioperative interventions.
Overall Study Verbal Agreement Withdrawn	4	2
Overall Study Consent Withdrawn	9	6
Overall Study Surgery Cancelled	4	4
Overall Study Found Ineligible for Study	4	3
Overall Study Consent Not Obtained for Other Reasons	3	3
Overall Study Intervention Not Done and No Data Collected	0	1

Baseline Characteristics

An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study

Baseline characteristics by cohort

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of perioperative interventions.	Total n=751 Participants Total of all reporting groups
Age, Continuous	62.4 years STANDARD_DEVIATION 12.0 • n=5 Participants	61.1 years STANDARD_DEVIATION 13.5 • n=7 Participants	61.7 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	170 Participants n=7 Participants	360 Participants n=5 Participants
Sex: Female, Male Male	182 Participants n=5 Participants	209 Participants n=7 Participants	391 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) White	278 Participants n=5 Participants	294 Participants n=7 Participants	572 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	43 Participants n=5 Participants	47 Participants n=7 Participants	90 Participants n=5 Participants
ARISCAT Total Score	40.9 score on a scale STANDARD_DEVIATION 7.6 • n=5 Participants	41.0 score on a scale STANDARD_DEVIATION 7.2 • n=7 Participants	41.0 score on a scale STANDARD_DEVIATION 7.4 • n=5 Participants

PRIMARY outcome

Timeframe: Postoperative Days 0 through 7

Population: Individual PPCs experienced by participants in both study arms.

The distribution of the number and severity of accumulated post-operative pulmonary complications (PPCs) between the control and intervention groups during the first 7 days after surgery.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number and Severity of Postoperative Pulmonary Complications Between Participant Groups Grade 0 (none)	84 complications	73 complications
Number and Severity of Postoperative Pulmonary Complications Between Participant Groups Grade 1 (mild)	35 complications	51 complications
Number and Severity of Postoperative Pulmonary Complications Between Participant Groups Grade 2 (moderate)	225 complications	211 complications
Number and Severity of Postoperative Pulmonary Complications Between Participant Groups Grade 3 (severe)	27 complications	41 complications
Number and Severity of Postoperative Pulmonary Complications Between Participant Groups Gade 4 (ventilatory failure)	1 complications	3 complications

SECONDARY outcome

Timeframe: Postoperative Days 0 through 7

Individual grade 3 and 4 postoperative pulmonary complications within 7 days after the day of the surgery.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Grade 1 and 2 Postoperative Pulmonary Complications	260 Participants	262 Participants

SECONDARY outcome

Timeframe: Postoperative Days 7, 30, and 90

Individual grade 3 and 4 postoperative pulmonary complications within 7, 30, and 90 days after the day of the surgery.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications Most Severe PPC Grade 3 or 4 by POD 7	28 Participants	44 Participants
Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications Most Severe PPC Grade 3 or 4 by POD 30	32 Participants	49 Participants
Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications Most Severe PPC Grade 3 or 4 by POD 90	35 Participants	53 Participants

SECONDARY outcome

Timeframe: Postoperative Days 0 through 7

Presence of any hypoxemia (as defined in PPC grade 1 and 2) within 7 days after the day of the surgery.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Hypoxemia by Postoperative Day 7	263 Participants	284 Participants

SECONDARY outcome

Timeframe: Days 0 through 7 after the day of surgery

Presence of atelectasis (radiological confirmation + either temperature >37.5°C or abnormal lung symptoms/signs) by day 7 after the date of surgery.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Atelectasis by Postoperative Day 7	59 Participants	70 Participants

SECONDARY outcome

Timeframe: Days 0 through 7

Incidence of suspected (radiological evidence without bacteriological confirmation) and proved (radiological evidence and documentation of pathological organism) pneumonia by day 7 after the date of surgery.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Pneumonia (Suspected and Proved) by Postoperative Day 7	18 Participants	28 Participants

SECONDARY outcome

Timeframe: Days 0 through 7

Number of participants with ventilatory dependence (Grade 3, non-invasive or invasive ventilation < 48h) or failure (Grade 4, postoperative non-invasive or invasive ventilation dependence ≥ 48h) by day 7 after the date of surgery.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Ventilatory Dependence or Failure by Postoperative Day 7	15 Participants	22 Participants

SECONDARY outcome

Timeframe: Up to 7 days post-surgery

Number of time (hours or days) spent in the postoperative oxygen therapy or other respiratory support

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Length of Postoperative Oxygen Support	19.2 hours Interval 4.7 to 49.4	14.6 hours Interval 4.7 to 42.7

SECONDARY outcome

Timeframe: Day 0

The incidence of both intraoperative hypoxemia (SpO2 < 85%) and rescue recruitment maneuvers during surgery. Received unplanned RM or PEEP titrations or adjustments during surgery for oxygenation or ventilation rescue.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Both Intraoperative Hypoxemia and Rescue Recruitment Maneuvers	21 Participants	6 Participants

SECONDARY outcome

Timeframe: Day 0

Number of participants with hypotension, bradycardia, tachycardia, arrhythmias, new ST-segment changes and cardiac arrest

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Intraoperative Cardiovascular Events	18 Participants	21 Participants

SECONDARY outcome

Timeframe: Days 0 through 7, 30, and 90

Number of days the participant has spent in the hospital since the day of the surgery.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Length of Hospital Stay	6.8 days Standard Deviation 5.9	7.2 days Standard Deviation 6.1

SECONDARY outcome

Timeframe: After the date of discharge to day 90

The number of participants with hospital readmission(s), other than to the Intensive Care Unit, if admitted.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Other Hospital Readmission(s) After Initial Discharge	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 0 to 7

Number of participants with arrhythmia, paralytic ileus, surgical site infection, infection (source uncertain), acute renal failure, and systemic inflammatory response syndrome.

Outcome measures

Measure	Usual Care n=372 Participants Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=379 Participants This arm will receive the bundle of interventions. Preoperative Education: Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization: PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. Individualization of Neuromuscular Blockade: Administration of neuromuscular blocking agents and their reversal will be done based on established protocol. Postoperative Incentive Spirometry: Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance. Postoperative Ambulation: Participants will be encouraged to adhere to prescription of early ambulation.
Number of Participants With Any Major Extrapulmonary Complications	43 Participants	48 Participants

Adverse Events

Usual Care

Serious events: 35 serious events

Other events: 19 other events

Deaths: 5 deaths

Intervention

Serious events: 35 serious events

Other events: 36 other events

Deaths: 6 deaths

Serious adverse events

Measure	Usual Care n=396 participants at risk Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=398 participants at risk This arm will receive the bundle of perioperative interventions.
General disorders Serious Adverse Events	8.8% 35/396 • Number of events 63 • Days 0 through 7, 30, and 90. Results reported are AEs and SAEs collected by day 90.	8.8% 35/398 • Number of events 47 • Days 0 through 7, 30, and 90. Results reported are AEs and SAEs collected by day 90.

Other adverse events

Measure	Usual Care n=396 participants at risk Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	Intervention n=398 participants at risk This arm will receive the bundle of perioperative interventions.
General disorders Non-serious Adverse Events	4.8% 19/396 • Number of events 44 • Days 0 through 7, 30, and 90. Results reported are AEs and SAEs collected by day 90.	9.0% 36/398 • Number of events 66 • Days 0 through 7, 30, and 90. Results reported are AEs and SAEs collected by day 90.

Additional Information

Dr. Marcos F. Vidal Melo

Columbia University Medical Center

Phone: 2123424799

Email: mv2869@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place