The primary objective of this study is to assess postoperative Apnea-Hypopnea Index (AHI) changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA. The secondary objective of this…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
slaap gerelateerde stoornissen in respiratie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is Apnea-Hypopnea Index.
Secondary outcome
Secondary and tertiary endpoints are 30 days complications rate, and parameters
for sleep architecture and sleep related breathing (in minutes and percentages;
oxygenation desaturation index (ODI), Rapid eye movement (REM) sleep, deep
sleep, light sleep, wake time, REM AHI , Respiratory disturbance index (RDI),
Total sleep time, saturation <90%, mean saturation, mean saturation during
desaturations, number of desaturations).
Background summary
Bariatric surgery is a highly effective and sustainable treatment against
obesity. Recently there has been a trend towards Same-Day Discharge (SDD)
bariatric surgery. SDD bariatric surgery has proven to be safe, when proper
discharge criteria are used. However, there is no consensus or guideline for
discharge criteria for SDD bariatric surgery. In particular, discharge criteria
for patients with obstructive sleep apnea (OSA) diverge between hospitals. In
some, but not all hospitals, having (untreated) OSA is a contra-indication for
SDD bariatric surgery.
In Rijnstate hospital, bariatric patients are not routinely tested for OSA
preoperatively, meaning that they potentially have undiagnosed OSA. Having
potentially undiagnosed OSA, is not a contra-indication for SDD bariatric
surgery in Rijnstate hospital. Hospitals could be hesitant for SDD bariatric
surgery in patients with OSA, because it is known that the apnea hypopnea index
(AHI) increases postoperatively. In a population without obesity, the highest
postoperative AHI was found during the third postoperative night. During this
third postoperative night, patients with a normal postoperative course will
already sleep at home, both after inpatient and SDD bariatric surgery. This
raises the question whether having (untreated) OSA should be a
contra-indication for SDD bariatric surgery. However, it is unknown if the same
postoperative changes in AHI and sleep architecture occur in patients
undergoing bariatric surgery.
Study objective
The primary objective of this study is to assess postoperative Apnea-Hypopnea
Index (AHI) changes during the first and third night after Same-Day Discharge
bariatric surgery in patients with potentially untreated OSA. The secondary
objective of this study is to compare postoperative AHI changes between
patients with a pre-operative AHI of 0-14 or >=15. The tertiary objective of
this study is to describe and compare pre- and postoperative sleep
architecture.
Study design
This is a prospective observational study. AHI and sleep architecture will be
assessed and compared before and after Same-Day discharge (SDD) bariatric
surgery during the first and third postoperative night with Home Sleep Apnea
Tests.
Study burden and risks
For this study, patients have to fill in two short questionnaires (ESS and
STOP-BANG, completion time of maximum 15 minutes) and will undergo three
non-invasive Home Sleep Apnea Tests. No extra visits to the hospital or
prolonged hospital stay is required during this study. This study cannot be
carried out without the selected patient population. If our hypothesis is
correct then more patients will be eligible for SDD bariatric surgery, which
will be beneficial for both patients and hospitals. Therefore, the potential
benefits outweigh the (minimal) burden of this study.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
- Rijnstate criteria for SDD bariatric surgery:
- Age >=18 years
- During the first postoperative night an adult person (=caregiver)
must be
present at the home or residence of the patient, to seek medical attention
if needed
- Both patient and caregiver must speak and read the Dutch language
- During the first postoperative night the patients must reside within
a 60- minute radius of Rijnstate hospital (Arnhem)
- Undergo primary bariatric surgery (RYGB or SG)
- In possession and able to use a smartphone
Exclusion criteria
- Rijnstate exclusion criteria for SDD bariatric surgery
- Not living in the Netherlands
- Patients from psychiatric wards, inmates of prisons and other state
institutions
- Insulin dependent diabetes
- Patients with active implants such as ICD and pacemaker
- Patients using a beta-blocker
- Patients diagnosed with OSA but without treatment
- Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric
banding)
- Diagnosed OSA with treatment (CPAP, oral appliances)
- Professional drivers
- Use of alpha blockers
- Unable to speak or read the Dutch language
- Not in possession or not able to use a smartphone
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86035.091.23 |