An Anesthesia-Centered Bundle to Reduce Postoperative Pul... | NCT04108130

NCT04108130

ID	Type	Description	Link
HL140177	Other Identifier	MGH
5UH3HL140177-03	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Description Module

Detailed Description

Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 million additional days of hospitalization. Abdominal surgery is the field with the largest absolute number of PPCs. The long-term goal is to develop and implement perioperative strategies to eliminate PPCs. Whereas PPCs are as significant and lethal as cardiac complications, research in the field has received much less attention, and strategies to minimize PPCs are regrettably limited. Recently, the investigators and others have suggested a crucial role of anesthesia related interventions such as ventilatory strategies, and administration and reversal of neuromuscular blocking agents in reducing PPCs. These findings are consistent with the beneficial effects of lung protective ventilation during the adult respiratory distress syndrome (ARDS). While surgical patients differ substantially from ARDS patients as most have no or limited lung injury at the start of surgery, intraoperative anesthetic and abdominal surgery interventions result in lung derecruitment and predispose to or produce direct and indirect, potentially multiple-hit, lung injury. Thus, effective anesthetic strategies aiming at early lung protection in this group of patients are greatly needed. Indeed, the current lack of evidence results in wide and unexplained variability in anesthetic practices creating a major public health issue as some practices within usual care appear to be suboptimal and even potentially injurious. The investigators hypothesize that an anesthesia-centered bundle, based on recent findings and focused on perioperative lung protection, will minimize multiple and synergistic factors responsible for the multiple-hit perioperative pulmonary dysfunction and result in decreased incidence and severity of PPCs. Founded on strong preliminary data, we will leverage a network of US academic centers to study this hypothesis in two aims: Aim 1. To compare the number and severity of PPCs in participants receiving an individualized perioperative anesthesia-centered bundle to those in participants receiving usual anesthetic care during open abdominal surgery. For this, the investigators propose to conduct a prospective multicenter randomized controlled pragmatic trial with a blinded assessor in a total of 750 studied participants. The bundle will consist of optimal mechanical ventilation comprising individualized positive end-expiratory pressure to maximize respiratory system compliance and minimize driving pressures, individualized use of neuromuscular blocking agents and their reversal, and postoperative lung expansion and early mobilization; Aim 2. To assess the effect of the proposed bundle on plasma levels of lung injury biomarkers. The investigators theorize that our intervention will minimize overinflation and atelectasis reducing plasma levels of biomarkers of lung inflammatory, epithelial, and endothelial injury. Such mechanistic insights will facilitate bundle dissemination and support adoption as it has for lung protective ventilation for ARDS. At the end of this project, the investigators expect to change clinical practice by establishing a new and clinically feasible anesthesia-centered strategy to reduce perioperative lung morbidity.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care	No Intervention	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
Intervention	Experimental	This arm will receive the bundle of interventions.	Other: Preoperative Education Procedure: Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization Other: Individualization of Neuromuscular Blockade Procedure: Postoperative Incentive Spirometry Behavioral: Postoperative Ambulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative Education	Other	Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and Severity of Postoperative Pulmonary Complications Between Participant Groups	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.	Postoperative Days 0 through 7

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Grade 1 and 2 Postoperative Pulmonary Complications	Individual grade 3 and 4 postoperative pulmonary complications within 7 days after the day of the surgery.	Postoperative Days 0 through 7
Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications

Eligibility Module

Name	Affiliation	Role
Marcos F Vidal Melo, MD	Columbia University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California - San Francisco		San Francisco	California	94115	United States
Stanford University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24894577	Background	PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
31157366	Background	Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology; Bluth T, Serpa Neto A, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE Collaborative Group; Bluth T, Bobek I, Canet JC, Cinnella G, de Baerdemaeker L, Gama de Abreu M, Gregoretti C, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann MW, Jaber S, Laffey J, Licker MJ, Markstaller K, Matot I, Mills GH, Mulier JP, Pelosi P, Putensen C, Rossaint R, Schmitt J, Schultz MJ, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H. Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial. JAMA. 2019 Jun 18;321(23):2292-2305. doi: 10.1001/jama.2019.7505.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
FG001	Intervention	This arm will receive the bundle of perioperative interventions.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 2, 2023	Sep 27, 2024

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.4± 12.0 BG00161.1± 13.5 BG00261.7± 12.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000190 BG001170 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

ARISCAT Total Score

The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score is used to categorize the risk of postoperative pulmonary complications in patients undergoing non-cardiothoracic surgery. It is composed by preoperative arterial oxygen saturation, acute respiratory infection during the previous month, age, preoperative anemia, upper abdominal or intrathoracic surgery, surgical duration, and emergency surgery. Values range from a minimum of 0 to a maximum of 123, with risk categories based on the score value: low risk < 26, intermediate risk 26-44, and high risk ≥45.

Mean

Standard Deviation

score on a scale

Title

Denominators

Categories

Title	Measurements
	BG00040.9± 7.6 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number and Severity of Postoperative Pulmonary Complications Between Participant Groups

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.

Individual PPCs experienced by participants in both study arms.

Posted

Number

complications

Postoperative Days 0 through 7

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Units	Counts
Participants	OG000372 OG001379

Title

Denominators

Categories

Grade 0 (none)

Title	Measurements
	OG00084 OG00173

Grade 1 (mild)

Title	Measurements
	OG000

Secondary

Number of Participants With Grade 1 and 2 Postoperative Pulmonary Complications

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

Posted

Count of Participants

Participants

Postoperative Days 0 through 7

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications

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

Posted

Count of Participants

Participants

Postoperative Days 7, 30, and 90

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Number of Participants With Hypoxemia by Postoperative Day 7

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

Posted

Count of Participants

Participants

Postoperative Days 0 through 7

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Number of Participants With Atelectasis by Postoperative Day 7

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

Posted

Count of Participants

Participants

Days 0 through 7 after the day of surgery

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Number of Participants With Pneumonia (Suspected and Proved) by Postoperative Day 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.

Posted

Count of Participants

Participants

Days 0 through 7

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Number of Participants With Ventilatory Dependence or Failure by Postoperative Day 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.

Posted

Count of Participants

Participants

Days 0 through 7

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Length of Postoperative Oxygen Support

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

Posted

Median

Inter-Quartile Range

hours

Up to 7 days post-surgery

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Number of Participants With Both Intraoperative Hypoxemia and Rescue Recruitment Maneuvers

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.

Posted

Count of Participants

Participants

Day 0

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Number of Participants With Intraoperative Cardiovascular Events

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

Posted

Count of Participants

Participants

Day 0

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Length of Hospital Stay

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

Posted

Mean

Standard Deviation

days

Days 0 through 7, 30, and 90

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Number of Participants With Other Hospital Readmission(s) After Initial Discharge

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

Posted

Count of Participants

Participants

After the date of discharge to day 90

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Secondary

Number of Participants With Any Major Extrapulmonary Complications

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

Posted

Count of Participants

Participants

Days 0 to 7

ID	Title	Description
OG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
OG001	Intervention	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.	5	396	35	396	19	396
EG001	Intervention	This arm will receive the bundle of perioperative interventions.	6	398	35	398	36	398

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy

ID	Title	Description
BG000	Usual Care	Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
BG001	Intervention	This arm will receive the bundle of perioperative interventions.
BG002	Total	Total of all reporting groups