The primary objective of this study is to assess the effect of preventive oxygen therapy on sleep disordered breathing during the first postoperative night after bariatric surgery. The secondary objective of this study is to observe the effect of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Slaapstoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Aneu hypopneu index
Secondary outcome
30 days complications rate, nursing intervention 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). Score of the Epworth Sleepiness Scale
(ESS).
Background summary
The prevalence of obstructive sleep apnea (OSA) in the bariatric surgery
population is high and mostly undiagnosed. The best perioperative strategy to
manage sleep apnea in bariatric patients remains unclear. A recent study found
that monitoring patients with pulsoximetry and giving them preventive oxygen
therapy during the first postoperative night is safe and cost effective. In a
population with patients with OSA but without obesity, no significant
difference in apnea hypopnea index (AHI) was found between patients with and
without oxygen therapy during the first postoperative night. The question was
raised if preventive oxygen therapy during the first postoperative night after
bariatric surgery is needed
Study objective
The primary objective of this study is to assess the effect of preventive
oxygen therapy on sleep disordered breathing during the first postoperative
night after bariatric surgery. The secondary objective of this study is to
observe the effect of preventive oxygen therapy on complication rate, nursing
intervention rate and sleep architecture. The tertiary objective is to assess
the effect of opioid use on AHI and sleep architecture.
Study design
This is a randomized controlled non-inferiority trial consisting of two arms;
Arm A: First postoperative night in the hospital with preventive oxygen therapy
(standard care),
Arm B: First postoperative night in hospital without preventive oxygen therapy
(intervention).
Sleep related breathing and sleep architecture will be assessed during the
first postoperative night with a non invasive sleep test.
Intervention
During the first postoperative night at the hospital patients in arm B will
not receive preventive oxygen therapy.
Study burden and risks
Patients are asked to fill in two short questionnaires (ESS and STOP BANG) and
will undergo an in hospital sleep test. This sleep test is not invasive. No
extra visits to the hospital or prolongation of hospital stay is required for
this study. Patients in the intervention arm will not receive oxygen therapy
during the first post-operative night in the hospital. We are convinced that
this can be done safely, because patients are in a controlled environment
(hospital) and will still be continuously monitored. If desaturations occur,
the nurse can intervene by for example waking up the patient or can still start
with oxygen therapy
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
Patients who undergo primary bariatric surgery (Roux-Y gastric bypass or
Gastric Sleeve), Age: >18- years, speak and read the Dutch language
Exclusion criteria
- Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric
banding), age < 18 years, Diagnosed OSA with treatment (CPAP, oral
appliances), Professional drivers, Use of alpha blockers, Unable to speak or
read the Dutch language, patients with same-day discharge
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 | NL84729.091.23 |