Obstructive Sleep Apnea (OSA)SATBARNCT07174674
Desaturations and Nursing Interventions in Patients Receiving Supplemental Oxygen Therapy After Metabolic and Bariatric Surgery
An observational study of Obstructive Sleep Apnea (OSA) and Bariatric Surgery, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The goal of this observational study is to learn about the effect of supplemental oxygen therapy during the first night after bariatric and metabolic surgery in a population that is not (routinely) tested for obstructive sleep apnea preoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Bariatric Surgery
- How many people
- 563 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Sep 2022to 6 Oct 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary bariatric and metabolic surgery, with a overnight stay at the nursing ward of Rijnstate Hospital (Arnhem, the Netherlands). With exclusion of patients with treated OSA or diagnosis of chronic obstructive pulmonary disease.
Who may be able to join
- Undergoing primary metabolic and bariatric surgery
- Overnight hospital stay
Who cannot join
- Undergoing secundary metabolic and bariatric surgery (e.g. redo surgery)
- Having treated obstructive sleep apnea (CPAP, oral application)
- Having chronic obstructive pulmonary disease
- No overnight hospital stay at the nursing ward (same-day discharge or overnight stay at medium or intensive care)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Vitalys obesity clinic, part of Rijnstate Hospital
Arnhem, Gelderland, 6815 AD
About this study
Official title: Saturation and Nursing Interventions in Patients Receiving Supplemental Oxygen Therapy During the First Night After Metabolic and Bariatric Surgery
The goal of this observational study is to learn about the effect of supplemental oxygen therapy during the first night after bariatric and metabolic surgery in a population that is not (routinely) tested for obstructive sleep apnea preoperatively.
The main question to answer in this study is:
How many desaturations occur while participants receive supplemental oxygen therapy and how many, and what type of nursing interventions are needed? Another question we want to answer is: are there characteristics that seems to increase the risk of developing a desaturation?
Read the detailed description
This is a prospective observational study that aims to characterize the number of desaturations and nursing interventions in a population with a unknown structive sleep apnea status receiving supplemental oxygen therapy during the first night after metabolic and bariatric surgery. The secondary aim is to to identify patient characteristics that are associated with a higher risk of developing desaturations.
Methods:
Participants receive standard of care, which includes 2 liters of supplemental oxygen therapy during the first postoperative night after metabolic and bariatric surgery while being continously monitored.
The desaturations, saturation and number and type of nursing intervention were collected along with patient characteristics (see outcomes) Sample size: A population proportion sample size was used, a CI 95%, margin of error 5% , proportion of 0.50, gave a required sample size of 385 participants.
Mann Whitney U-test (continuous data) and Fishers exact test (categorical data) are used to compare spo2 and nursing interventions between participants with and without desaturations.
Binary logistic regression will be used to estimate the risk for developing desaturations.
- Conditions
- Obstructive Sleep Apnea (OSA), Bariatric Surgery
- Keywords
- obstructive sleep apnea, bariatric surgery, oxygen therapy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Alle study participants will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of desaturations per patient
Participants were continuously monitored and all desaturations (spo2<90%) were collected.
Measured: First postoperative night
Number of nursing interventions
If nurses had to intervene because of a desaturation or to prevent a desaturation (e.g. waking patient, putting back nasal cannula, increasing oxygen flow)
Measured: First postoperative night
Type of nursing intervention
which nursing intervention the nursed provided was documented on a form (e.g. putting back nasal cannula, increasing oxygen flow, jaw thrust)
Measured: First postoperative night
Secondary outcomes (13)
The effect of the patient characterisic "sex" on the risk of developing desaturations
Measured: First postoperative night
The effect of the patient characterisic "age" on the risk of developing desaturations
Age on day of surgery
Measured: First postoperative night
The effect of the patient characterisic "body mass index" on the risk of developing desaturations
Body mass index on day of surgery
Measured: First postoperative night
The effect of the patient characterisic "smoking status" on the risk of developing desaturations
Somking status before surgery
Measured: First postoperative night
The effect of the patient characterisic "chronic benzodiazepine use" on the risk of developing desaturations
Use of benzodiazepine at home
Measured: First postoperative night
The effect of the patient characterisic "diabetes mellitus type 2" on the risk of developing desaturations
Preoperative diabetes mellitus type 2 status (yes/no)
Measured: First postoperative night
The effect of the patient characterisic "hypertension" on the risk of developing desaturations
Preoperative hypertension status (yes/no)
Measured: First postoperative night
The effect of the patient characterisic "dyslipidemia" on the risk of developing desaturations
Preoperative dyslipidemia status (yes/no)
Measured: First postoperative night
The effect of operating time on the risk of developing desaturations
Duration of the surgery
Measured: First postoperative night
The effect postoperatively used morphine milligram equivalent on the risk of developing desaturations
The postoperative used opioid were converted to oral morphine milligram equivalent
Measured: First postoperative night
The effect intraoperatively used morphine milligram equivalent on the risk of developing desaturations
The intraoperative used opioid were converted to oral morphine milligram equivalent
Measured: First postoperative night
The effect of rocuronium on the risk of developing desaturations
The intraoperative used dose of rocuronium
Measured: First postoperative night
The effect of sugammadex on the risk of developing desaturations
The intraoperative use of sugammadex
Measured: First postoperative night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Sep 2022
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric J Hazebroek, MD, PhD, Principal investigator, Vitalys obesity clinic, part of Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174674
- Sponsor's protocol ID
- 2022-2107
- Acronym
- SATBAR
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD is not necessary
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saturation and Nursing Interventions in Patients Receiving Supplemental Oxygen Therapy During the First Night After Metabolic and Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07174674
- Acronym / sponsor ID
- SATBAR / 2022-2107
- Conditions
- Obstructive Sleep Apnea (OSA), Bariatric Surgery
- Keywords
- obstructive sleep apnea, bariatric surgery, oxygen therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 16 Sep 2025 (actual)
- 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.
The goal of this observational study is to learn about the effect of supplemental oxygen therapy during the first night after bariatric and metabolic surgery in a population that is not (routinely) tested for obstructive sleep apnea preoperatively.
The main question to answer in this study is:
How many desaturations occur while participants receive supplemental oxygen therapy and how many, and what type of nursing interventions are needed? Another question we want to answer is: are there characteristics that seems to increase the risk of developing a desaturation?
Detailed description
This is a prospective observational study that aims to characterize the number of desaturations and nursing interventions in a population with a unknown structive sleep apnea status receiving supplemental oxygen therapy during the first night after metabolic and bariatric surgery. The secondary aim is to to identify patient characteristics that are associated with a higher risk of developing desaturations.
Methods:
Participants receive standard of care, which includes 2 liters of supplemental oxygen therapy during the first postoperative night after metabolic and bariatric surgery while being continously monitored.
The desaturations, saturation and number and type of nursing intervention were collected along with patient characteristics (see outcomes) Sample size: A population proportion sample size was used, a CI 95%, margin of error 5% , proportion of 0.50, gave a required sample size of 385 participants.
Mann Whitney U-test (continuous data) and Fishers exact test (categorical data) are used to compare spo2 and nursing interventions between participants with and without desaturations.
Binary logistic regression will be used to estimate the risk for developing desaturations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | –Alle study participants will receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary bariatric and metabolic surgery, with a overnight stay at the nursing ward of Rijnstate Hospital (Arnhem, the Netherlands). With exclusion of patients with treated OSA or diagnosis of chronic obstructive pulmonary disease.
Key inclusion criteria (2 listed)
- Undergoing primary metabolic and bariatric surgery
- Overnight hospital stay
Key exclusion criteria (4 listed)
- Undergoing secundary metabolic and bariatric surgery (e.g. redo surgery)
- Having treated obstructive sleep apnea (CPAP, oral application)
- Having chronic obstructive pulmonary disease
- No overnight hospital stay at the nursing ward (same-day discharge or overnight stay at medium or intensive care)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of desaturations per patient
Time frame: First postoperative night
Participants were continuously monitored and all desaturations (spo2<90%) were collected.
Number of nursing interventions
Time frame: First postoperative night
If nurses had to intervene because of a desaturation or to prevent a desaturation (e.g. waking patient, putting back nasal cannula, increasing oxygen flow)
Type of nursing intervention
Time frame: First postoperative night
which nursing intervention the nursed provided was documented on a form (e.g. putting back nasal cannula, increasing oxygen flow, jaw thrust)
13 secondary outcomes
The effect of the patient characterisic "sex" on the risk of developing desaturations
Time frame: First postoperative night
The effect of the patient characterisic "age" on the risk of developing desaturations
Time frame: First postoperative night
The effect of the patient characterisic "body mass index" on the risk of developing desaturations
Time frame: First postoperative night
The effect of the patient characterisic "smoking status" on the risk of developing desaturations
Time frame: First postoperative night
The effect of the patient characterisic "chronic benzodiazepine use" on the risk of developing desaturations
Time frame: First postoperative night
The effect of the patient characterisic "diabetes mellitus type 2" on the risk of developing desaturations
Time frame: First postoperative night
The effect of the patient characterisic "hypertension" on the risk of developing desaturations
Time frame: First postoperative night
The effect of the patient characterisic "dyslipidemia" on the risk of developing desaturations
Time frame: First postoperative night
The effect of operating time on the risk of developing desaturations
Time frame: First postoperative night
The effect postoperatively used morphine milligram equivalent on the risk of developing desaturations
Time frame: First postoperative night
The effect intraoperatively used morphine milligram equivalent on the risk of developing desaturations
Time frame: First postoperative night
The effect of rocuronium on the risk of developing desaturations
Time frame: First postoperative night
The effect of sugammadex on the risk of developing desaturations
Time frame: First postoperative night
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 19 Sep 2025.
- Individual participant dataSharing planned: No. Sharing of IPD is not necessary
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Eric J Hazebroek, MD, PhD principal investigator
Vitalys obesity clinic, part of Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA) and Bariatric Surgery, run by Rijnstate Hospital at 1 site in Netherlands.
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 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 19 Sep 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 Netherlands. 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?
Number of desaturations per patient (time frame: First postoperative night). The study lists 3 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 19 Sep 2025.