Trial Outcomes & Findings for Determination of the Predictors of Nocturnal Desaturation in Postpartum Women (NCT NCT02330055)
NCT ID: NCT02330055
Last Updated: 2018-07-06
Results Overview
Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
48 hours after delivery
Results posted on
2018-07-06
Participant Flow
Participant milestones
| Measure |
Non-elevated Upper Body Position
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
| Measure |
Non-elevated Upper Body Position
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
|---|---|---|
|
Overall Study
technical issues
|
2
|
0
|
|
Overall Study
participant forgot to wear device
|
5
|
5
|
|
Overall Study
data for less than 60 minutes
|
3
|
3
|
|
Overall Study
participant did not sleep
|
0
|
1
|
Baseline Characteristics
Determination of the Predictors of Nocturnal Desaturation in Postpartum Women
Baseline characteristics by cohort
| Measure |
Non-elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 5 • n=7 Participants
|
33 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Delivery Type
Vaginal
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Delivery Type
Cesarean section
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours after deliveryOxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery
Outcome measures
| Measure |
Non-elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
|---|---|---|
|
SpO2 < 90%
All Types of Delivery
|
0.4 minutes
Interval 0.0 to 6.4
|
0.0 minutes
Interval 0.0 to 0.5
|
|
SpO2 < 90%
Vaginal Delivery
|
0.1 minutes
Interval 0.0 to 0.3
|
0.0 minutes
Interval 0.0 to 0.1
|
|
SpO2 < 90%
Cesarean Section
|
4.1 minutes
Interval 0.9 to 19.8
|
0.2 minutes
Interval 0.0 to 1.8
|
SECONDARY outcome
Timeframe: 48 hours after deliveryODI (oxygen desaturation index), assessed by pulse oximetry during the first night after delivery. ODI is defined as number of desaturation events per hour; a desaturation event is defined as drop in SpO2 of 3% or more from baseline SpO2. Baseline SpO2 is defined as the mean SpO2 of the SpO2 values taken over the preceding 120 seconds.
Outcome measures
| Measure |
Non-elevated Upper Body Position
n=50 Participants
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
n=49 Participants
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
|---|---|---|
|
Oxygen Desaturation Index > 3
|
4.0 1/hr
Interval 2.6 to 6.5
|
3.2 1/hr
Interval 2.2 to 5.8
|
SECONDARY outcome
Timeframe: 48 hours after deliveryBasic pulseoximetry in the first night after delivery
Outcome measures
| Measure |
Non-elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
|---|---|---|
|
Minimal & Mean SpO2
Basal (Mean) SPO2
|
94.7 percentage of hemoglobin in the blood
Interval 93.4 to 95.4
|
95.2 percentage of hemoglobin in the blood
Interval 94.5 to 96.1
|
|
Minimal & Mean SpO2
Nadir (Minimum) SPO2
|
87 percentage of hemoglobin in the blood
Interval 82.0 to 90.0
|
90 percentage of hemoglobin in the blood
Interval 87.0 to 92.0
|
SECONDARY outcome
Timeframe: 48 hours after deliveryPopulation: The number analyzed per row differs from the overall number because the analysis was distinguished down by type of delivery and upper body position. Thus, 20 patients belong to each group as seen below.
A Perioperative sleep apnea prediction (P-SAP) Score. This score ranges from 0 to 69, 0 representing low risk of obstructive sleep apnea and 69 representing high risk of obstructive sleep apnea.
Outcome measures
| Measure |
Non-elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
|---|---|---|
|
P-SAP Score
Vaginal Delivery
|
1 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 0.0 to 2.0
|
|
P-SAP Score
Cesarean Section
|
2 units on a scale
Interval 2.0 to 3.0
|
2 units on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 48 hours after deliveryThe STOP BANG (This abbreviation consists of the first letter of each question in the questionnaire. S-Snore, T-Tired, O-Observed stop in breathing, P-High blood pressure, B-BMI, A - Age, N-Neck circumference, G-Gender. This questionnaire is a proven tool that can be used to screen for obstructive sleep apnea (OSA). This tool will assess if you are low, moderate or high risk group for sleep apnea. Scores range from 0-8. 0 indicates low risk for sleep apnea, 8 indicates high risk for sleep apnea.
Outcome measures
| Measure |
Non-elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
|---|---|---|
|
STOP-BANG Score
Vaginal Delivery
|
1 units on a scale
Interval 0.0 to 1.0
|
1 units on a scale
Interval 0.0 to 1.0
|
|
STOP-BANG Score
Cesarean Section
|
1 units on a scale
Interval 1.0 to 2.0
|
2 units on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 48 hours after deliveryAssessment of intensity of acute pain. Measured from 0-10, 0 being no pain and 10 being highest level of pain.
Outcome measures
| Measure |
Non-elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
|---|---|---|
|
Pain-score on a Verbal Numerical Rating Scale
Vaginal Delivery
|
3 units on a scale
Interval 1.0 to 4.0
|
3 units on a scale
Interval 2.0 to 5.0
|
|
Pain-score on a Verbal Numerical Rating Scale
Cesarean Section
|
4 units on a scale
Interval 2.0 to 6.0
|
4 units on a scale
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: 48 Hours after deliveryAs measured in beats per minute
Outcome measures
| Measure |
Non-elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire
|
Forty-five Degrees Elevated Upper Body Position
n=40 Participants
If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.
The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Forty-five degrees elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
|
|---|---|---|
|
Average Pulse Rate
|
78.8 beats per minute
Interval 69.9 to 86.1
|
75.2 beats per minute
Interval 68.6 to 87.3
|
Adverse Events
Non-elevated Upper Body Position
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Forty-five Degrees Elevated Upper Body Position
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
Dr. Matthias Eikermann
Beth Israel Deaconess Medical Center
Phone: 6176673364
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place