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| Name | Class |
|---|---|
| VU University of Amsterdam | OTHER |
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The goal of this observational study is to learn about the relationship between sleep alterations following anesthesia and their relationship to a potential increase of obstructive sleep apnea (OSA) severity.
Our main question is: Is there an increased severity of OSA on the third post-operative night compared to the first post-operative night and does this have a relation with REM sleep?
Participants enrolled in this research are all diagnosed with OSA, with or without treament. All participants will be asked to wear a watchlike device called WATCHPAT to identify sleep paterns and register apneic (no breathing) and hypopneic (insufficient breathing) incidents. We ask our participants to wear this device for 8-10 hours a night when they are a sleep.
The study is a prospective, observational, single center cohort study on electively scheduled adult surgical patients at the Amsterdam UMC, Amsterdam, The Netherlands.
Patients eligible for inclusion will be identified at the pre-operative screening at the outpatient clinic and contacted and included prior to the day of surgery.
Patients will sign an informed consent. Alternatively patients will be identified by an electronic algoritm which will analyse the next weeks elective surgery list. the algorithm analyzes for sleap apnea; in the patient problem list in their electronic patient file. Patients that have not been identified at the outpatient clinic will be able to be identified as eligible for inclusion via this route.
Measurement will start post-operatively at the recovery ward. All data will be registered with a non-invasive device, the WatchPAT (ZOLL medical). This device will measure apneic and hypopneic incidents, reported as apneu-hypopneu index (AHI) and vital signs such as blood pressure, heart rate and oxygen saturation. In addition the Watchpat will register REM-sleep via actigrapy. Other patient characteristics and demographics will be retrieved from the electronic patient file (EPIC).
These measurements will be started within 30 minutes of arriving at the recovery on the day of surgery continuing on into the first night at the PACU unit. On night 2 and 3 post-operatively participants will be asked to wear the device on the ward when going to sleep for the night. measurement period at the ward will be 8-10 hours.
For results on our primary outcome:
difference in mean of AHI and desaturations on night one compared to night three.
We aimed to detect a difference in mean of an AHI of 0.8 in a design with 3 repeated measurements when assuming a standard deviation of 2 and a very conservative between level correlation of 0. In order to detect a similar difference with a power of 80% and a significance level of 0.05, assuming a drop-out rate of 5%, we will need a sample size of 35 patients.
When patients are lost to follow up, or have incomplete measurements, defined as no functional data on sleep, AHI and desaturations in night 1 or night 3. Where a sleep time of 1,5 hours a night is minimally needed for complete calculations on AHI.
We will use descriptive statistics to present the characteristics of patients, using mean with standard deviation, or median with interquartile range for continuous data and as absolute frequencies with proportions for categorical data. The main outcome measure will be compared using a paired t-test. Correlations will be calculated using Pearsons correlation coefficient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients scheduled for elective surgery with a diagnosis of obstructive sleep apnea (OSA) |
|
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| Measure | Description | Time Frame |
|---|---|---|
| AHI and Desaturations on night one and three after surgery | To compare the AHI and desaturations on night one and night three after surgery | from directly post operatively up untill the morning after the third night following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Desaturations post operatively | Assess the amount of patients with na increase of respiratory events (saturation <90%) later than 6 hours after surgery. | The first six hours after surgery |
| AHI directly post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment with an expected admittance of a minimum of 3 days
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin V.H. Rutten, Msc, MD | Contact | +31205669111 | 28657 | m.v.rutten@amsterdamumc.nl |
| Jeroen Hermanides, Prof. Dr. | Contact | +310205669111 | 62533 | j.hermanides@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jeroen Hermanides, Prof. Dr. | AmsterdamUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AmsterdamUMC, location AMC | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
Study-protocol: will be available upon request SAP ,ICV, CSR will all be able on request. Data will be anonymized when data shared is patient specific.
There is no analytical code involved in our study. therefore this will not be shared.
Study protocol, ICF (standard model) with SAP are available upon request as of now. (september 2024) Data will be available until 5 year after publishing.
Only the researchteam will have direct acces to the researchdata and specific patient data.
External requests will be evaluated by the principal investigator
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compare the difference between AHI and desaturations in the first six hours after surgery to the first night after surgery.
| directly post-operatively up untill the next morning (max 24 hours) |
| Changes in total REM sleep | Changes in total REM sleep comparing night 1,2 and 3. | The first three nights following surgery |
| Changes in AHI, REM-AHI and desaturations over time | To analyze the changes over time in AHI, REM-AHI, (respiratory events related tot REM-sleep cycle) and desaturations. | Night one, two and three. |
| REM sleep and AHI | Correlation between REM Sleep and respiratory events measured as AHI | From directly post-operatively up untill the morning after the third night. |
| Comparison of patients with treatment and patients without treatment | Comparing AHI and desaturations between patients with either a MRA or CPAP treatment to those without any form of treatment or other treatment than MRA and CPAP. | DIrectly post-operatively up untill the morning after night three |
| Morfine and AHI/desaturations | Compare respiratory events measured as AHI or desaturations compared to opioid consumption, measured as morphine equivalents. identifying different time-frames.
also identifying different modalities if applicable.
| from directly post-operatively to the morning after the third night. |
| Amsterdam UMC location VuMC | Recruiting | Amsterdam | 1081 HV | Netherlands |
|
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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