Obstructive Sleep Apnea, Respiratory Complication
Conditions
Keywords
Respiratory Complication, Clinical Decision Support, Sugammadex
Brief summary
The purpose of this study is to: 1. 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. 2. 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: 1. 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). 2. 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.
Interventions
Sugammadex administered to patients within the clinical best practice pathway.
Sponsors
Study design
Intervention model description
Historical prospective comparative effectiveness clinical trial
Eligibility
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Fitness for Discharge From the Recovery Room | One year prior to study intervention to one year following implementation of study intervention | The time the anesthesiologist places the discharge order |
| Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%) | One year prior to study intervention to one year following implementation of study intervention | Documentation oxygen saturation below 90% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Supplemental Oxygen Needed by High-risk Patients | One year prior to study intervention to one year following implementation of study intervention | Duration of supplemental oxygen needed by high-risk patients before and after intervention |
| Postoperative Reintubation Rate | One year prior to study intervention to one year following implementation of study intervention | Rate of postoperative reintubation |
| Percentage of Patients Who Had Intraoperative Lung Protective Ventilation | One year prior to study intervention to one year following implementation of study intervention | Percentage of patients who had intraoperative lung protective ventilation prior to extubation |
| Percentage of Patients Who Had Train of Four Ratio Measurement | One year prior to study intervention to one year following implementation of study intervention | Percentage of patients who had Train of Four ratio measurement prior to extubation |
| Number of Patients With Unplanned Upgrade of Care | One year prior to study intervention to one year following implementation of study intervention | Number of patients with unplanned upgrade of care |
| Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%) | One year prior to study intervention to one year following implementation of study intervention | Documentation of oxygen saturation below 95% |
Countries
United States
Participant flow
Recruitment details
Pre-Trial Cohort Timeframe: Patients from 2015, before sugammadex was available on the market (pre-2016). Purpose: Served as a historical control group to compare outcomes before the introduction of sugammadex. Size: 6,824 patients. Post-Trial Cohort Timeframe: Patients enrolled between February 2022 and May 2024. Purpose: Identified and enrolled via an automated system using Best Practice Advisories (BPAs) in the EHR. Size: 5,424
Participants by arm
| Arm | Count |
|---|---|
| CDS Pathway 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
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | CDS Pathway |
|---|---|
| Age, Customized ≥18 | 12248 Participants |
| Race/Ethnicity, Customized Post-Trial Race American Indian or Alaska Native | 62 Participants |
| Race/Ethnicity, Customized Post-Trial Race Asian | 504 Participants |
| Race/Ethnicity, Customized Post-Trial Race Black or African American | 379 Participants |
| Race/Ethnicity, Customized Post-Trial Race Middle Eastern/North African | 119 Participants |
| Race/Ethnicity, Customized Post-Trial Race Native Hawaiian or Other Pacific Islander | 29 Participants |
| Race/Ethnicity, Customized Post-Trial Race Unknown / Not Specified | 1142 Participants |
| Race/Ethnicity, Customized Post-Trial Race White | 3189 Participants |
| Race/Ethnicity, Customized Pre-Trial Race American Indian or Alaska Native | 36 Participants |
| Race/Ethnicity, Customized Pre-Trial Race Asian | 605 Participants |
| Race/Ethnicity, Customized Pre-Trial Race Black or African American | 578 Participants |
| Race/Ethnicity, Customized Pre-Trial Race Middle Eastern/North African | 34 Participants |
| Race/Ethnicity, Customized Pre-Trial Race Native Hawaiian or Other Pacific Islander | 37 Participants |
| Race/Ethnicity, Customized Pre-Trial Race Unknown / Not Specified | 1198 Participants |
| Race/Ethnicity, Customized Pre-Trial Race White | 4336 Participants |
| Region of Enrollment United States | 12248 participants |
| Sex/Gender, Customized Post-Trial Sex Female | 2897 Participants |
| Sex/Gender, Customized Post-Trial Sex Male | 2525 Participants |
| Sex/Gender, Customized Post-Trial Sex Unknown | 2 Participants |
| Sex/Gender, Customized Pre-Trial Sex Female | 3575 Participants |
| Sex/Gender, Customized Pre-Trial Sex Male | 3249 Participants |
| Sex/Gender, Customized Pre-Trial Sex Unknown | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6,824 | 0 / 5,424 |
| other Total, other adverse events | 0 / 6,824 | 0 / 5,424 |
| serious Total, serious adverse events | 0 / 6,824 | 8 / 5,424 |
Outcome results
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)
Documentation oxygen saturation below 90%
Time frame: One year prior to study intervention to one year following implementation of study intervention
Population: Pre-Trial 6,824. Post-Trial 5,424.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDS Pathway | Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%) | Pre-Trial | 18 Participants |
| CDS Pathway | Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%) | Post-Trial | 9 Participants |
| CDS Pathway | Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%) | No Incidence | 12,221 Participants |
Time to Fitness for Discharge From the Recovery Room
The time the anesthesiologist places the discharge order
Time frame: One year prior to study intervention to one year following implementation of study intervention
Population: Pre-Trial 6,824. Post-Trial 5,424.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CDS Pathway | Time to Fitness for Discharge From the Recovery Room | Pre-Trial | 165.64 Minutes | Standard Deviation 89.69 |
| CDS Pathway | Time to Fitness for Discharge From the Recovery Room | Post-Trial | 154.60 Minutes | Standard Deviation 86.17 |
Duration of Supplemental Oxygen Needed by High-risk Patients
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
Population: This outcome was not measured due to impacted hospital regulations during COVID-19. Hospital regulations restricted this measurement to be taken as intake volume was low and therefore hospital administration deemed it uncollectable at the time. Therefore, this measurement was never completed during the duration of the study as our team were required to follow updated hospital regulations.
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)
Documentation of oxygen saturation below 95%
Time frame: One year prior to study intervention to one year following implementation of study intervention
Population: Pre-Trial 6,824. Post-Trial 5,424.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDS Pathway | Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%) | Pre-Trial | 421 Participants |
| CDS Pathway | Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%) | Post-Trial | 1170 Participants |
| CDS Pathway | Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%) | No Incidence | 10,657 Participants |
Number of Patients With Unplanned Upgrade of Care
Number of patients with unplanned upgrade of care
Time frame: One year prior to study intervention to one year following implementation of study intervention
Population: Pre-Trial 6,824. Post-Trial 5,424.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDS Pathway | Number of Patients With Unplanned Upgrade of Care | Pre-Trial | 128 Participants |
| CDS Pathway | Number of Patients With Unplanned Upgrade of Care | Post-Trial | 16 Participants |
| CDS Pathway | Number of Patients With Unplanned Upgrade of Care | No Incidence | 12,104 Participants |
Percentage of Patients Who Had Intraoperative Lung Protective Ventilation
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
Population: This outcome was not measured due to impacted hospital regulations during COVID-19. Hospital regulations restricted this measurement to be taken as intake volume was low and therefore hospital administration deemed it uncollectable at the time. Therefore, this measurement was never completed during the duration of the study as our team were required to follow updated hospital regulations.
Percentage of Patients Who Had Train of Four Ratio Measurement
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
Population: Analysis was only completed for Post-Trial participants equaling 5,424. Analysis could not be collected for Pre-Trial group as the Pre-Trial group was collected retrospectively and this measurement was not implemented into care until the prospective collection of the Post-Trial group. Therefore, we could not obtain the Pre-Trial group's measurements as these measurements had never been collected to obtain retrospectively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDS Pathway | Percentage of Patients Who Had Train of Four Ratio Measurement | 2704 Participants |
Postoperative Reintubation Rate
Rate of postoperative reintubation
Time frame: One year prior to study intervention to one year following implementation of study intervention
Population: Analysis was completed for Post-Trial participants equaling 5,424.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDS Pathway | Postoperative Reintubation Rate | Pre-Trial | 13 Participants |
| CDS Pathway | Postoperative Reintubation Rate | Post-Trial | 4 Participants |