Respiratory ComplicationNCT03010852
Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery
A study testing Focused incentive spirometer education and monitoring in people with Respiratory Complication, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and even at hospital discharge. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Complication
- What is being tested?
- Focused incentive spirometer education and monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having planned elective bariatric surgery at University of Colorado Hospital
Who cannot join
- Emergency procedure
- Oxygen therapy within the previous 30 days
- Smoking within the previous 30 days
- Inability or refusal to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on patient compliance with IS effort and frequency. The investigators hypothesize that a focused education preoperatively on IS for POH and intensive monitoring of patient compliance with IS therapy in the early postoperative period shortens postoperative oxygen therapy, decreases POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients receiving standard of care.
- Conditions
- Respiratory Complication
- Being tested
- Focused incentive spirometer education and monitoring
- Keywords
- Bariatric Surgery, Spirometry Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused incentive spirometer education and monitoringBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard of care incentive spirometer | No intervention | Patients in the SOC cohort will not receive the preoperative education and only one postoperative visit per day to collect their self-reported use of IS, if prescribed, and respiratory symptoms but avoiding increasing their awareness of POH, O2 therapy and IS. |
| Focused incentive spirometer education and monitoring | Experimental | One of the study investigators will meet eligible patients in the preoperative visit to the UCH Weight Loss Surgery clinic, inform and consent the patient and introduce the first education on IS therapy, highlighting its possible benefits and the importance of compliance (patient's inspiratory effort and frequency). This IS education will be repeated in the preoperative area immediately before surgery. The site will then follow the patient postoperatively. The site will directly check on the patient in the PACU and later in his/her hospital room at least 3 times a day during the first 3 days or sooner if their O2 therapy is discontinued for 2h. During these PO check ups The site will reinforce the IS use, monitor the patient's performance of IS and ask him/her about other respiratory symptoms. Receives: Behavioral: Focused incentive spirometer education and monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of at least one episode of moderate/severe hypoxemic event
Measured: During first post operative day
Secondary outcomes (2)
Duration of postoperative oxygen therapy
The duration of postoperative oxygen therapy will be evaluated from the arrival to the post-anesthesia care unit to successful discontinuation of oxygen therapy lasting greater than 2 hours.
Measured: Up to 7 days after surgery
Presence of postoperative oxygen therapy and postoperative hypoxemic events
The development of postoperative hypoxemic events will be evaluated from the initiation of post-operative oxygen therapy through hospital discharge.
Measured: Up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionAug 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory ComplicationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Fernandez-Bustamante, M.D., Ph.D., Principal investigator, University of Colorado, School of Medicine - Department of Anesthesology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010852
- Sponsor's protocol ID
- 16-1268
- Status last verified
- Feb 2021
- First submitted
- 7 Dec 2016
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: N/A IPD will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03010852
- Acronym / sponsor ID
- 16-1268
- Conditions
- Respiratory Complication
- Keywords
- Bariatric Surgery, Spirometry Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on patient compliance with IS effort and frequency. The investigators hypothesize that a focused education preoperatively on IS for POH and intensive monitoring of patient compliance with IS therapy in the early postoperative period shortens postoperative oxygen therapy, decreases POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients receiving standard of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care incentive spirometer | No intervention | –Patients in the SOC cohort will not receive the preoperative education and only one postoperative visit per day to collect their self-reported use of IS, if prescribed, and respiratory symptoms but avoiding increasing their awareness of POH, O2 therapy and IS. |
| Focused incentive spirometer education and monitoring | Experimental | Behavioral: Focused incentive spirometer education and monitoringOne of the study investigators will meet eligible patients in the preoperative visit to the UCH Weight Loss Surgery clinic, inform and consent the patient and introduce the first education on IS therapy, highlighting its possible benefits and the importance of compliance (patient's inspiratory effort and frequency). This IS education will be repeated in the preoperative area immediately before surgery. The site will then follow the patient postoperatively. The site will directly check on the patient in the PACU and later in his/her hospital room at least 3 times a day during the first 3 days or sooner if their O2 therapy is discontinued for 2h. During these PO check ups The site will reinforce the IS use, monitor the patient's performance of IS and ask him/her about other respiratory symptoms. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having planned elective bariatric surgery at University of Colorado Hospital
Key exclusion criteria (4 listed)
- Emergency procedure
- Oxygen therapy within the previous 30 days
- Smoking within the previous 30 days
- Inability or refusal to provide consent
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 |
|---|---|---|
| Focused incentive spirometer education and monitoring | Behavioural | Focused incentive spirometer education and monitoring |
Primary outcome
Frequency of at least one episode of moderate/severe hypoxemic event
Time frame: During first post operative day
2 secondary outcomes
Duration of postoperative oxygen therapy
Time frame: Up to 7 days after surgery
Presence of postoperative oxygen therapy and postoperative hypoxemic events
Time frame: Up to 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No. N/A IPD will not be shared with other researchers
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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.
Ana Fernandez-Bustamante, M.D., Ph.D. principal investigator
University of Colorado, School of Medicine - Department of Anesthesology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused incentive spirometer education and monitoring in people with Respiratory Complication, run by University of Colorado, Denver 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 1 inclusion and 4 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 12 Feb 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of at least one episode of moderate/severe hypoxemic event (time frame: During first post operative day). 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 12 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.