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

NCT07174674 | Completed

• 1 other identifier: 2022-2107
• Study Type: observational
• Target: 563
• Locations: 1 country
• Sites: 1

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?

Conditions

Obstructive Sleep Apnea (OSA); Bariatric Surgery

Keywords

obstructive sleep apnea; bariatric surgery; oxygen therapy

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (13)

• 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

  First postoperative night

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

  First postoperative night

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

  First postoperative night

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

  First postoperative night

Other Outcomes (1)

• Saturation during the night

  First postoperative night

Study Arms (1)

All study participants

Alle study participants will receive standard of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Undergoing primary metabolic and bariatric surgery
• Overnight hospital stay

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Vitalys obesity clinic, part of Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Eric J Hazebroek, MD, PhD

  Vitalys obesity clinic, part of Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 16, 2025
• Study Start: September 15, 2022
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)