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Completed

NCT Number: NCT07174674

Desaturations and Nursing Interventions in Patients Receiving Supplemental Oxygen Therapy 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?

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Bariatric Surgery Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vitalys obesity clinic, part of Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of desaturations per patient

    Time frame: First postoperative night

    Participants were continuously monitored and all desaturations (spo2<90%) were collected.

  2. 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)

  3. 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)

Secondary outcomes

  1. The effect of the patient characterisic "sex" on the risk of developing desaturations

    Time frame: First postoperative night

  2. The effect of the patient characterisic "age" on the risk of developing desaturations

    Time frame: First postoperative night

    Age on day of surgery

  3. The effect of the patient characterisic "body mass index" on the risk of developing desaturations

    Time frame: First postoperative night

    Body mass index on day of surgery

  4. The effect of the patient characterisic "smoking status" on the risk of developing desaturations

    Time frame: First postoperative night

    Somking status before surgery

  5. The effect of the patient characterisic "chronic benzodiazepine use" on the risk of developing desaturations

    Time frame: First postoperative night

    Use of benzodiazepine at home

  6. The effect of the patient characterisic "diabetes mellitus type 2" on the risk of developing desaturations

    Time frame: First postoperative night

    Preoperative diabetes mellitus type 2 status (yes/no)

  7. The effect of the patient characterisic "hypertension" on the risk of developing desaturations

    Time frame: First postoperative night

    Preoperative hypertension status (yes/no)

  8. The effect of the patient characterisic "dyslipidemia" on the risk of developing desaturations

    Time frame: First postoperative night

    Preoperative dyslipidemia status (yes/no)

  9. The effect of operating time on the risk of developing desaturations

    Time frame: First postoperative night

    Duration of the surgery

  10. The effect postoperatively used morphine milligram equivalent on the risk of developing desaturations

    Time frame: First postoperative night

    The postoperative used opioid were converted to oral morphine milligram equivalent

  11. The effect intraoperatively used morphine milligram equivalent on the risk of developing desaturations

    Time frame: First postoperative night

    The intraoperative used opioid were converted to oral morphine milligram equivalent

  12. The effect of rocuronium on the risk of developing desaturations

    Time frame: First postoperative night

    The intraoperative used dose of rocuronium

  13. The effect of sugammadex on the risk of developing desaturations

    Time frame: First postoperative night

    The intraoperative use of sugammadex

Other outcomes

  1. Saturation during the night

    Time frame: First postoperative night

    Every 10 minutes a mean saturation from the continuous monitoring was was saved.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Acronym: SATBAR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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