Trial Outcomes & Findings for A Pilot Study of Biomarkers in Obstructive Sleep Apnea (NCT NCT02325687)
NCT ID: NCT02325687
Last Updated: 2020-04-21
Results Overview
The primary outcome, the levels of cytokine IL-6 in serum of OSA-treated, OSA-untreated and control patients presenting for knee replacement surgery with planned spinal or combined spinal-epidural anesthesia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Intraoperatively - Pre-Incision
Results posted on
2020-04-21
Participant Flow
Participant milestones
| Measure |
Treated OSA (CPAP-compliant)
Treated OSA patients will have previously been diagnosed with OSA, and are currently CPAP-compliant. CPAP compliance is defined by daily use of a CPAP machine for at least 4 hours. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Untreated OSA (Non-CPAP-compliant)
Patients in the untreated OSA group will have previously been diagnosed with OSA, but for some reason do not use a CPAP machine every night. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Control (No Suspicion of OSA)
Patients in the control group will not have previously been diagnosed with OSA, and are currently not at high risk. We will determine overall risk for OSA using the STOP-BANG questionnaire. Patients with a STOP-BANG score \<3 are considered to have minimal risk for OSA and will be included in the control group.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
19
|
|
Overall Study
COMPLETED
|
12
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all participants analyzed fall onto the same range of age
Baseline characteristics by cohort
| Measure |
Treated OSA (CPAP-compliant)
n=16 Participants
Treated OSA patients will have previously been diagnosed with OSA, and are currently CPAP-compliant. CPAP compliance is defined by daily use of a CPAP machine for at least 4 hours. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Untreated OSA (Non-CPAP-compliant)
n=15 Participants
Patients in the untreated OSA group will have previously been diagnosed with OSA, but for some reason do not use a CPAP machine every night. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Control (No Suspicion of OSA)
n=19 Participants
Patients in the control group will not have previously been diagnosed with OSA, and are currently not at high risk. We will determine overall risk for OSA using the STOP-BANG questionnaire. Patients with a STOP-BANG score \<3 are considered to have minimal risk for OSA and will be included in the control group.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Continuous
|
67.81 years
n=5 Participants • Not all participants analyzed fall onto the same range of age
|
63.066 years
n=7 Participants • Not all participants analyzed fall onto the same range of age
|
71.68 years
n=5 Participants • Not all participants analyzed fall onto the same range of age
|
67.86 years
n=4 Participants • Not all participants analyzed fall onto the same range of age
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Intraoperatively - Pre-IncisionPopulation: The samples have been collected but the assays have not been performed due to the integrity of the samples.
The primary outcome, the levels of cytokine IL-6 in serum of OSA-treated, OSA-untreated and control patients presenting for knee replacement surgery with planned spinal or combined spinal-epidural anesthesia.
Outcome measures
| Measure |
Treated OSA (CPAP-compliant)
n=12 Participants
Treated OSA patients will have previously been diagnosed with OSA, and are currently CPAP-compliant. CPAP compliance is defined by daily use of a CPAP machine for at least 4 hours. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Untreated OSA (Non-CPAP-compliant)
n=12 Participants
Patients in the untreated OSA group will have previously been diagnosed with OSA, but for some reason do not use a CPAP machine every night. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Control (No Suspicion of OSA)
n=13 Participants
Patients in the control group will not have previously been diagnosed with OSA, and are currently not at high risk. We will determine overall risk for OSA using the STOP-BANG questionnaire. Patients with a STOP-BANG score \<3 are considered to have minimal risk for OSA and will be included in the control group.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
|---|---|---|---|
|
Serum IL-6 (Interleukin 6) Levels
|
NA pg/mL
Standard Deviation NA
The samples have been collected but the assays have not been performed due to the integrity of the samples.
|
NA pg/mL
Standard Deviation NA
The samples have been collected but the assays have not been performed due to the integrity of the samples.
|
NA pg/mL
Standard Deviation NA
The samples have been collected but the assays have not been performed due to the integrity of the samples.
|
SECONDARY outcome
Timeframe: Intraoperatively - Pre-IncisionBiological samples were collected, but not analyzed for the presence and levels of particular cytokines (TNF-alpha, IL-6, IL-8, IL-10) and neurotrophins (BDNF(brain-derived neurotrophic factor), β-NGF (nerve growth factor)) due to the integrity of the samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intraoperatively - Pre-IncisionCSF (cerebrospinal fluid) was planned to be screened for the differential expression of proteins.The samples have been collected, but the assays have not been performed due to the integrity of the samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout hospital stay, or an average of 1 week.We will look at the incidence of respiratory complications (hypoxia; need for respiratory intervention), cardiac complications (MI/ACS or arrhythmias) and CNS (central nervous system) complications (delirium, TIA or CVA). Parameters will be scored for presence or absence over the entire length of stay.
Outcome measures
| Measure |
Treated OSA (CPAP-compliant)
n=12 Participants
Treated OSA patients will have previously been diagnosed with OSA, and are currently CPAP-compliant. CPAP compliance is defined by daily use of a CPAP machine for at least 4 hours. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Untreated OSA (Non-CPAP-compliant)
n=12 Participants
Patients in the untreated OSA group will have previously been diagnosed with OSA, but for some reason do not use a CPAP machine every night. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Control (No Suspicion of OSA)
n=13 Participants
Patients in the control group will not have previously been diagnosed with OSA, and are currently not at high risk. We will determine overall risk for OSA using the STOP-BANG questionnaire. Patients with a STOP-BANG score \<3 are considered to have minimal risk for OSA and will be included in the control group.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
|---|---|---|---|
|
Number of Participants With Respiratory, Cardiac, and/or CNS (Central Nervous System) Complications
Need for nasal airway
|
2 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Respiratory, Cardiac, and/or CNS (Central Nervous System) Complications
Need for oral airway/airway adjunct
|
4 participants
|
4 participants
|
0 participants
|
|
Number of Participants With Respiratory, Cardiac, and/or CNS (Central Nervous System) Complications
Need for continuous chin lifts
|
7 participants
|
8 participants
|
0 participants
|
|
Number of Participants With Respiratory, Cardiac, and/or CNS (Central Nervous System) Complications
Need for intubation
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Respiratory, Cardiac, and/or CNS (Central Nervous System) Complications
Need for mechanical ventilation
|
2 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Throughout hospital stay, or an average of 1 week.Incidences of intraoperative obstructive respiratory events will be collected perioperatively in the operating room by the anesthesiologist
Outcome measures
| Measure |
Treated OSA (CPAP-compliant)
n=12 Participants
Treated OSA patients will have previously been diagnosed with OSA, and are currently CPAP-compliant. CPAP compliance is defined by daily use of a CPAP machine for at least 4 hours. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Untreated OSA (Non-CPAP-compliant)
n=12 Participants
Patients in the untreated OSA group will have previously been diagnosed with OSA, but for some reason do not use a CPAP machine every night. We will determine if patients are CPAP-compliant by looking at their medical records and pre-operative assessments, as well as directly verifying compliance with the patient.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
Control (No Suspicion of OSA)
n=13 Participants
Patients in the control group will not have previously been diagnosed with OSA, and are currently not at high risk. We will determine overall risk for OSA using the STOP-BANG questionnaire. Patients with a STOP-BANG score \<3 are considered to have minimal risk for OSA and will be included in the control group.
Intervention: Lumbar Puncture (Standard-of-Care)
Lumbar Puncture (Standard-of-Care): All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
|
|---|---|---|---|
|
Incidence of Intraoperative Obstructive Respiratory Events
Apneic events
|
8 participants
|
9 participants
|
0 participants
|
|
Incidence of Intraoperative Obstructive Respiratory Events
Hypoapnea
|
2 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Throughout stay in the recovery unit, or an average of 1-2 days.Levels of blood oxygen saturation will be measured via arterial blood gas levels. These will be drawn as standard-of-care.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout stay in the recovery unit, or an average of 1-2 days.Levels of blood oxygen saturation throughout the length of stay in the recovery unit will be measured via arterial blood gas levels, found in the patient's electronic medical record
Outcome measures
Outcome data not reported
Adverse Events
Treated OSA (CPAP-compliant)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Untreated OSA (Non-CPAP-compliant)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control (No Suspicion of OSA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kethy Jules-Elysee
Hospital for Special Surgery, Anesthesiology Department
Phone: 212-606-1206
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place