Respiratory ComplicationPhase 4NCT04263363
Applying Best Clinical Practices to Patients at High Risk of Respiratory Complications
A Phase 4 study testing Sugammadex 100 MG/ML [Bridion] in people with Respiratory Complication and Obstructive Sleep Apnea, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Complication, Obstructive Sleep Apnea
- What is being tested?
- Sugammadex 100 MG/ML [Bridion]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,248 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2022to 7 May 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
About this study
Official title: A Prospective Digital Quality Improvement Project to Apply Best Clinical Practices to Patients at High Risk of Respiratory Complications
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.
Read the 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.
- Conditions
- Respiratory Complication, Obstructive Sleep Apnea
- Being tested
- Sugammadex 100 MG/ML [Bridion]
- Keywords
- Respiratory Complication, Clinical Decision Support, Sugammadex
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex 100 MG/ML [Bridion]Drug
Also called Bridion
Sugammadex administered to patients within the clinical best practice pathway.
| Study group | Role | What they receive |
|---|---|---|
| CDS pathway | Experimental | 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 Receives: Drug: Sugammadex 100 MG/ML [Bridion] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to "Fitness for Discharge" From the Recovery Room
The time the anesthesiologist places the discharge order
Measured: One year prior to study intervention to one year following implementation of study intervention
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)
Documentation oxygen saturation below 90%
Measured: One year prior to study intervention to one year following implementation of study intervention
Secondary outcomes (6)
Percentage of Patients Who Had Intraoperative Lung Protective Ventilation
Percentage of patients who had intraoperative lung protective ventilation prior to extubation
Measured: One year prior to study intervention to one year following implementation of study intervention
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)
Documentation of oxygen saturation below 95%
Measured: One year prior to study intervention to one year following implementation of study intervention
Duration of Supplemental Oxygen Needed by High-risk Patients
Duration of supplemental oxygen needed by high-risk patients before and after intervention
Measured: One year prior to study intervention to one year following implementation of study intervention
Postoperative Reintubation Rate
Rate of postoperative reintubation
Measured: One year prior to study intervention to one year following implementation of study intervention
Number of Patients With Unplanned Upgrade of Care
Number of patients with unplanned upgrade of care
Measured: One year prior to study intervention to one year following implementation of study intervention
Percentage of Patients Who Had Train of Four Ratio Measurement
Percentage of patients who had Train of Four ratio measurement prior to extubation
Measured: One year prior to study intervention to one year following implementation of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start18 Feb 2022
- Primary completion7 May 2024
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory ComplicationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Historical prospective comparative effectiveness clinical trial
- Masking
- None (open label)
- Enrolment
- 12,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Eilon Gabel, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263363
- Sponsor's protocol ID
- Anes-Respiratory Dysfunction
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2020
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Digital Quality Improvement Project to Apply Best Clinical Practices to Patients at High Risk of Respiratory Complications
- ClinicalTrials.gov ID
- NCT04263363
- Acronym / sponsor ID
- Anes-Respiratory Dysfunction
- Conditions
- Respiratory Complication, Obstructive Sleep Apnea
- Keywords
- Respiratory Complication, Clinical Decision Support, Sugammadex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,248 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Historical prospective comparative effectiveness clinical trial
| Arm | Type | Receives |
|---|---|---|
| CDS pathway | Experimental | Drug: Sugammadex 100 MG/ML [Bridion]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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugammadex 100 MG/ML [Bridion]Also: BridionSugammadex administered to patients within the clinical best practice pathway. | Drug | CDS pathway |
Primary outcome
Time to "Fitness for Discharge" From the Recovery Room
Time frame: 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%)
Time frame: One year prior to study intervention to one year following implementation of study intervention
Documentation oxygen saturation below 90%
6 secondary outcomes
Percentage of Patients Who Had Intraoperative Lung Protective Ventilation
Time frame: One year prior to study intervention to one year following implementation of study intervention
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)
Time frame: One year prior to study intervention to one year following implementation of study intervention
Duration of Supplemental Oxygen Needed by High-risk Patients
Time frame: One year prior to study intervention to one year following implementation of study intervention
Postoperative Reintubation Rate
Time frame: One year prior to study intervention to one year following implementation of study intervention
Number of Patients With Unplanned Upgrade of Care
Time frame: One year prior to study intervention to one year following implementation of study intervention
Percentage of Patients Who Had Train of Four Ratio Measurement
Time frame: One year prior to study intervention to one year following implementation of study intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Respiratory Complication
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex 100 MG/ML [Bridion] in people with Respiratory Complication and Obstructive Sleep Apnea, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to "Fitness for Discharge" From the Recovery Room (time frame: One year prior to study intervention to one year following implementation of study intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.