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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study participants | Alle study participants will receive standard of care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of desaturations per patient | Participants were continuously monitored and all desaturations (spo2<90%) were collected. | 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) | 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) | First postoperative night |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of the patient characterisic "sex" on the risk of developing desaturations | First postoperative night | |
| The effect of the patient characterisic "age" on the risk of developing desaturations | Age on day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Saturation during the night | Every 10 minutes a mean saturation from the continuous monitoring was was saved. | First postoperative night |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Eric J Hazebroek, MD, PhD | Vitalys obesity clinic, part of Rijnstate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitalys obesity clinic, part of Rijnstate Hospital | Arnhem | Gelderland | 6815 AD | Netherlands |
Sharing of IPD is not necessary
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 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 | First postoperative night |
| The effect of the patient characterisic "smoking status" on the risk of developing desaturations | Somking status before surgery | First postoperative night |
| The effect of the patient characterisic "chronic benzodiazepine use" on the risk of developing desaturations | Use of benzodiazepine at home | 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) | First postoperative night |
| The effect of the patient characterisic "hypertension" on the risk of developing desaturations | Preoperative hypertension status (yes/no) | First postoperative night |
| The effect of the patient characterisic "dyslipidemia" on the risk of developing desaturations | Preoperative dyslipidemia status (yes/no) | First postoperative night |
| The effect of operating time on the risk of developing desaturations | Duration of the surgery | 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 | 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 | First postoperative night |
| The effect of rocuronium on the risk of developing desaturations | The intraoperative used dose of rocuronium | First postoperative night |
| The effect of sugammadex on the risk of developing desaturations | The intraoperative use of sugammadex | First postoperative night |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |