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Applying Best Clinical Practices to Patients at High Risk of Respiratory Complications

Primary Purpose

Respiratory Complication, Obstructive Sleep Apnea

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sugammadex 100 MG/ML [Bridion]
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Complication focused on measuring Respiratory Complication, Clinical Decision Support, Sugammadex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • UCLA Ronald Reagan or Santa Monica patients aged 18 and older who had a general anesthetic with either rocuronium or vecuronium.
  • Patients who receive sugammadex from the specified study supply

Exclusion Criteria:

  • Patients under the age of 18
  • Patients with a preoperative glomerular filtration rate less than 30 or on hemodialysis
  • Patients with known hypersensitivity to any of the following: rocuronium, vecuronium, sugammadex, neostigmine or glycopyrrolate
  • Patients with known neuromuscular disease
  • Patients who remain intubated after surgery or leave the operating room with a tracheostomy in-situ
  • Patients who did not receive reversal of neuromuscular blockade (with neostigmine in the pre-period or sugammadex in the post-period).

Sites / Locations

  • Ronald Reagan UCLA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CDS pathway

Arm Description

When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP

Outcomes

Primary Outcome Measures

Time to "fitness for discharge" from the recovery room
The time the anesthesiologist places the discharge order
Incidence of hypoxemia in the PACU (oxygen saturation below 90%)
Documentation oxygen saturation below 90%

Secondary Outcome Measures

Percentage of patients who had intraoperative lung protective ventilation
Percentage of patients who had intraoperative lung protective ventilation prior to extubation
Incidence of hypoxemia in the PACU (oxygen saturation below 95%)
Documentation of oxygen saturation below 95%
Duration of supplemental oxygen needed by high-risk patients
Duration of supplemental oxygen needed by high-risk patients before and after intervention
Postoperative reintubation rate
Rate of postoperative reintubation
Number of patients with unplanned upgrade of care
Number of patients with unplanned upgrade of care
Percentage of patients who had Train of Four ratio measurement
Percentage of patients who had Train of Four ratio measurement prior to extubation

Full Information

First Posted
January 17, 2020
Last Updated
May 8, 2023
Sponsor
University of California, Los Angeles
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04263363
Brief Title
Applying Best Clinical Practices to Patients at High Risk of Respiratory Complications
Official Title
A Prospective Digital Quality Improvement Project to Apply Best Clinical Practices to Patients at High Risk of Respiratory Complications
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to: Perform a retrospective analysis on data contained in the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction in the post-operative care unit (PACU) before and after the introduction of sugammadex into clinical practice. Develop and implement a clinical best practice pathway designed to prevent postoperative respiratory complications in higher risk patients (such as those with OSA or preexisting respiratory disease) using education and clinical decision support in patients.
Detailed Description
This will be a historical prospective comparative effectiveness clinical trial where the investigators plan to leverage their experience in extracting data from the EMR as well as creating robust CDS pathways in order to create and implement a pathway to promote use of best respiratory care in patients receiving general anesthesia who are at increased risk for postoperative respiratory dysfunction. The overall study will consist of two parts: Retrospective data analysis: The investigators will utilize the Perioperative Data Warehouse, a custom-built data warehouse, to study the effect of the introduction of sugammadex, a direct reversal agent for rocuronium, into clinical practice on time to "fitness for discharge" from the recovery room, as noted by the time the anesthesiologist places the discharge order, before and after intervention and postoperative respiratory dysfunction (as defined as duration of oxygen saturation below 90% in the PACU). Creation and implementation of a pathway to prevent postoperative respiratory dysfunction: The investigators will design and implement a perioperative decision support system which will identify high-risk patients and provide best practice recommendations via electronic clinical decision support reminders. Creation and implementation of a pathway to prevent postoperative respiratory dysfunction: In order to improve outcomes for high-risk patients who receive general anesthesia and paralysis the investigators will design and implement a perioperative decision support system which will identify high-risk patients and provide best practice recommendations via electronic clinical decision support reminders. While the exact parameters of the pathway will be designed based upon feedback from a group of quality leaders in the department, in general the pathway will function as follows: When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive an alert reminding them of the best practice guidelines for pulmonary management in high-risk patients. As part of the study roll-out the investigators will present these guidelines with their quality committee, but anticipate that they will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP. The investigators anticipate running the prospective portion of the study for a one year data collection period. Specifically, they will allow a one month "wash out" period for pathway go live, followed by one year of data collection during which the pathway is live. STUDY PROCEDURES Pathway Design The design of the pathway will undergo a well-established process that is designed to ensure buy-in and support from a large variety of providers within the Department of Anesthesiology and Perioperative Medicine at UCLA. The investigators will create a core group of individuals who represent key stakeholders in quality, informatics, and clinical decision making throughout our department. This group will be in charge of reviewing the existing literature and creating the pathway guidelines and associated decision support. The decision support will consist of preoperative alerts for high risk patients, intraoperative reminders for events such as ventilator settings and reversal as well as postoperative feedback on performance of identified best practices and outcomes. This pathway will include the recommendation of the use of sugammadex to reverse neuromuscular blockade and use of objective train of four (TOF) monitoring in high-risk individuals. This core group will then present the recommended pathway for approval to our quarterly Quality Council and then broader Faculty Meetings for approval. The investigators estimate that the total time for pathway design and creation will be approximately 6 months. Pathway Implementation After approval, the investigators will work with the EMR build team in order to ensure the necessary modification to the EMR. After the modifications are complete, the investigators will establish a "go-live" date. After an initial period during which the investigators will accommodate feedback and ensure that the modifications were made successfully, no further modifications to the respiratory pathway will be made. The investigators plan to keep this pathway in place for at least one year (the study period). Data Collection and Analysis As noted above, the team has the ability to automatically collect the data from the EMR for analysis purposes. After the one year implementation period investigators will extract the data elements noted above for the study period as well as an equivalent period prior to pathway implementation. The data will be analyzed for the overall application of best practices before and after as well as a change in primary and secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Complication, Obstructive Sleep Apnea
Keywords
Respiratory Complication, Clinical Decision Support, Sugammadex

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Historical prospective comparative effectiveness clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
13000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CDS pathway
Arm Type
Experimental
Arm Description
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Intervention Type
Drug
Intervention Name(s)
Sugammadex 100 MG/ML [Bridion]
Other Intervention Name(s)
Bridion
Intervention Description
Sugammadex administered to patients within the clinical best practice pathway.
Primary Outcome Measure Information:
Title
Time to "fitness for discharge" from the recovery room
Description
The time the anesthesiologist places the discharge order
Time Frame
One year prior to study intervention to one year following implementation of study intervention
Title
Incidence of hypoxemia in the PACU (oxygen saturation below 90%)
Description
Documentation oxygen saturation below 90%
Time Frame
One year prior to study intervention to one year following implementation of study intervention
Secondary Outcome Measure Information:
Title
Percentage of patients who had intraoperative lung protective ventilation
Description
Percentage of patients who had intraoperative lung protective ventilation prior to extubation
Time Frame
One year prior to study intervention to one year following implementation of study intervention
Title
Incidence of hypoxemia in the PACU (oxygen saturation below 95%)
Description
Documentation of oxygen saturation below 95%
Time Frame
One year prior to study intervention to one year following implementation of study intervention
Title
Duration of supplemental oxygen needed by high-risk patients
Description
Duration of supplemental oxygen needed by high-risk patients before and after intervention
Time Frame
One year prior to study intervention to one year following implementation of study intervention
Title
Postoperative reintubation rate
Description
Rate of postoperative reintubation
Time Frame
One year prior to study intervention to one year following implementation of study intervention
Title
Number of patients with unplanned upgrade of care
Description
Number of patients with unplanned upgrade of care
Time Frame
One year prior to study intervention to one year following implementation of study intervention
Title
Percentage of patients who had Train of Four ratio measurement
Description
Percentage of patients who had Train of Four ratio measurement prior to extubation
Time Frame
One year prior to study intervention to one year following implementation of study intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: UCLA Ronald Reagan or Santa Monica patients aged 18 and older who had a general anesthetic with either rocuronium or vecuronium. Patients who receive sugammadex from the specified study supply Exclusion Criteria: Patients under the age of 18 Patients with a preoperative glomerular filtration rate less than 30 or on hemodialysis Patients with known hypersensitivity to any of the following: rocuronium, vecuronium, sugammadex, neostigmine or glycopyrrolate Patients with known neuromuscular disease Patients who remain intubated after surgery or leave the operating room with a tracheostomy in-situ Patients who did not receive reversal of neuromuscular blockade (with neostigmine in the pre-period or sugammadex in the post-period).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eilon Gabel, MD
Phone
310-267-8693
Email
egabel@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie-Dee Sarovich, BS
Phone
424-832-6842
Email
ssarovich@mednet.ucla.edu
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ira Hofer, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Applying Best Clinical Practices to Patients at High Risk of Respiratory Complications

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