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Desaturations and Nursing Interventions in Patients Receiving Supplemental Oxygen Therapy After Metabolic and Bariatric Surgery

Saturation and Nursing Interventions in Patients Receiving Supplemental Oxygen Therapy During the First Night After Metabolic and Bariatric Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07174674
Acronym
SATBAR
Enrollment
563
Registered
2025-09-16
Start date
2022-09-15
Completion date
2023-10-06
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Obstructive Sleep Apnea (OSA)

Keywords

obstructive sleep apnea, bariatric surgery, oxygen therapy

Brief 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. 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.

Interventions

None listed

Sponsors

Rijnstate Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Undergoing primary metabolic and bariatric surgery * Overnight hospital stay

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Type of nursing interventionFirst postoperative nightwhich nursing intervention the nursed provided was documented on a form (e.g. putting back nasal cannula, increasing oxygen flow, jaw thrust)
Number of desaturations per patientFirst postoperative nightParticipants were continuously monitored and all desaturations (spo2\<90%) were collected.
Number of nursing interventionsFirst postoperative nightIf nurses had to intervene because of a desaturation or to prevent a desaturation (e.g. waking patient, putting back nasal cannula, increasing oxygen flow)

Secondary

MeasureTime frameDescription
The effect of the patient characterisic sex on the risk of developing desaturationsFirst postoperative night
The effect of the patient characterisic smoking status on the risk of developing desaturationsFirst postoperative nightSomking status before surgery
The effect of the patient characterisic chronic benzodiazepine use on the risk of developing desaturationsFirst postoperative nightUse of benzodiazepine at home
The effect of the patient characterisic diabetes mellitus type 2 on the risk of developing desaturationsFirst postoperative nightPreoperative diabetes mellitus type 2 status (yes/no)
The effect of the patient characterisic hypertension on the risk of developing desaturationsFirst postoperative nightPreoperative hypertension status (yes/no)
The effect of operating time on the risk of developing desaturationsFirst postoperative nightDuration of the surgery
The effect postoperatively used morphine milligram equivalent on the risk of developing desaturationsFirst postoperative nightThe postoperative used opioid were converted to oral morphine milligram equivalent
The effect intraoperatively used morphine milligram equivalent on the risk of developing desaturationsFirst postoperative nightThe intraoperative used opioid were converted to oral morphine milligram equivalent
The effect of rocuronium on the risk of developing desaturationsFirst postoperative nightThe intraoperative used dose of rocuronium
The effect of sugammadex on the risk of developing desaturationsFirst postoperative nightThe intraoperative use of sugammadex
The effect of the patient characterisic dyslipidemia on the risk of developing desaturationsFirst postoperative nightPreoperative dyslipidemia status (yes/no)
The effect of the patient characterisic age on the risk of developing desaturationsFirst postoperative nightAge on day of surgery
The effect of the patient characterisic body mass index on the risk of developing desaturationsFirst postoperative nightBody mass index on day of surgery

Other

MeasureTime frameDescription
Saturation during the nightFirst postoperative nightEvery 10 minutes a mean saturation from the continuous monitoring was was saved.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026