Sleep Disordered Breathing, Nocturnal Oxygen Desaturation, Upper Airway Edema
Conditions
Brief summary
The primary aim of the study is to evaluate the effect of the method of delivery (vaginal delivery vs. cesarean section) on oxygen saturation in the first postpartum night. The investigators hypothesize that nocturnal desaturation occurs more frequently in cesarean section compared with vaginal delivery, expressed as either the duration of SpO2 below 90% or the Oxygen Desaturation Index (ODI). The ODI is defined as number of oxygen desaturations by at least 3 % per hour. Furthermore, the investigators expect a higher pulse rate and a lower mean and minimum SpO2 in the cesarean section group compared with the vaginal delivery group. The secondary aim of the study is to investigate how the upper body position during sleep (45 degree elevated vs. non-elevated) affects the oxygen saturation during the first postpartum night. The investigators hypothesize that an upper body elevation to 45 degrees decreases the incidence of desaturation events, expressed as either the duration of SpO2 below 90% or the ODI , compared with a non-elevated body position within each delivery group (vaginal delivery or cesarean section). The third aim of the study is to identify independent predictors of nocturnal desaturation in postpartum women. To that end, the investigators will administer questionnaires and collect demographic and clinical data according to various obstructive sleep apnea screening scores, including the P-SAP, STOP-Bang, and Epworth Sleepiness Scale. The investigators will also ask the patient to rate the pain during the study night on a verbal numerical rating scale.
Detailed description
Sleep-disordered breathing is common in pregnancy, persisting into the early postpartum period. Postpartum airway obstruction is a main cause of anesthesia-related maternal death in North America. Upper airway edema following labor and delivery may impair pharyngeal anatomy, which can lead to increased vulnerability of the airway collapse during sleep. This study evaluates whether the kind of delivery (vaginal birth versus cesarean section) has an effect on nocturnal desaturation in the first night after delivery. Furthermore, the investigators examine if the upper body position during sleep has an effect on the occurrence of oxygen desaturation. In addition, the investigators evaluate if preexisting conditions, as indicated by a high P-SAP or STOP-Bang-score increase the likelihood of nocturnal desaturation.
Interventions
PROCEDUREForty-five degrees elevated upper body position
PROCEDUREnon-elevated upper body position
DEVICENoninvasive 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.
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 includes snoring, tiredness, observed apneas, blood pressure, Body Mass Index, age, neck circumference and gender. The investigators will ask the patient to answer the questionnaire and measure the neck circumference.
The Epworth Sleepiness Scale is a well-established clinical tool to quantify daytime sleepiness. It is clinically used for the diagnosis of sleep disorders. The investigators will ask the patient to complete the questionnaire and will specify that the questionnaire pertains to the patient's pre-admission condition.
OTHERP-SAP Score
The P-SAP Score is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The investigators will ask the patient to answer the questionnaire and will assess the Mallampati Score. The investigators will also measure the neck circumference and the Thyromental distance.
OTHERself-reported pain
A verbal numerical rating scale is used to asses the pain during the study-night.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Postpartum mothers within 24 hours of delivery * Age over 18 years. * Admitted to the Massachusetts General Hospital OB service for the delivery. * Interventions will be randomly assigned to the patients enrolled in this study
Exclusion criteria
* 1 Age under 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 < 90% | 48 hours after delivery | Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal & Mean SpO2 | 48 hours after delivery | Basic pulseoximetry in the first night after delivery |
| P-SAP Score | 48 hours after delivery | 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. |
| Oxygen Desaturation Index > 3 | 48 hours after delivery | ODI (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. |
| Pain-score on a Verbal Numerical Rating Scale | 48 hours after delivery | Assessment of intensity of acute pain. Measured from 0-10, 0 being no pain and 10 being highest level of pain. |
| Average Pulse Rate | 48 Hours after delivery | As measured in beats per minute |
| STOP-BANG Score | 48 hours after delivery | The 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | data for less than 60 minutes | 3 | 3 |
| Overall Study | participant did not sleep | 0 | 1 |
| Overall Study | participant forgot to wear device | 5 | 5 |
| Overall Study | technical issues | 2 | 0 |
Baseline characteristics
| Characteristic | Forty-five Degrees Elevated Upper Body Position | Non-elevated Upper Body Position | Total |
|---|---|---|---|
| Age, Continuous | 32.5 years STANDARD_DEVIATION 5 | 34.5 years STANDARD_DEVIATION 5.5 | 33 years STANDARD_DEVIATION 5 |
| Delivery Type Cesarean section | 20 Participants | 20 Participants | 40 Participants |
| Delivery Type Vaginal | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 31 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) White | 32 Participants | 25 Participants | 57 Participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 0 / 50 | 0 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 |
Outcome results
Primary
SpO2 < 90%
Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery
Time frame: 48 hours after delivery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Non-elevated Upper Body Position | SpO2 < 90% | All Types of Delivery | 0.4 minutes |
| Non-elevated Upper Body Position | SpO2 < 90% | Vaginal Delivery | 0.1 minutes |
| Non-elevated Upper Body Position | SpO2 < 90% | Cesarean Section | 4.1 minutes |
| Forty-five Degrees Elevated Upper Body Position | SpO2 < 90% | All Types of Delivery | 0.0 minutes |
| Forty-five Degrees Elevated Upper Body Position | SpO2 < 90% | Vaginal Delivery | 0.0 minutes |
| Forty-five Degrees Elevated Upper Body Position | SpO2 < 90% | Cesarean Section | 0.2 minutes |
Secondary
Average Pulse Rate
As measured in beats per minute
Time frame: 48 Hours after delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-elevated Upper Body Position | Average Pulse Rate | 78.8 beats per minute |
| Forty-five Degrees Elevated Upper Body Position | Average Pulse Rate | 75.2 beats per minute |
Secondary
Minimal & Mean SpO2
Basic pulseoximetry in the first night after delivery
Time frame: 48 hours after delivery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Non-elevated Upper Body Position | Minimal & Mean SpO2 | Basal (Mean) SPO2 | 94.7 percentage of hemoglobin in the blood |
| Non-elevated Upper Body Position | Minimal & Mean SpO2 | Nadir (Minimum) SPO2 | 87 percentage of hemoglobin in the blood |
| Forty-five Degrees Elevated Upper Body Position | Minimal & Mean SpO2 | Basal (Mean) SPO2 | 95.2 percentage of hemoglobin in the blood |
| Forty-five Degrees Elevated Upper Body Position | Minimal & Mean SpO2 | Nadir (Minimum) SPO2 | 90 percentage of hemoglobin in the blood |
Secondary
Oxygen Desaturation Index > 3
ODI (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.
Time frame: 48 hours after delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-elevated Upper Body Position | Oxygen Desaturation Index > 3 | 4.0 1/hr |
| Forty-five Degrees Elevated Upper Body Position | Oxygen Desaturation Index > 3 | 3.2 1/hr |
Secondary
Pain-score on a Verbal Numerical Rating Scale
Assessment of intensity of acute pain. Measured from 0-10, 0 being no pain and 10 being highest level of pain.
Time frame: 48 hours after delivery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Non-elevated Upper Body Position | Pain-score on a Verbal Numerical Rating Scale | Vaginal Delivery | 3 units on a scale |
| Non-elevated Upper Body Position | Pain-score on a Verbal Numerical Rating Scale | Cesarean Section | 4 units on a scale |
| Forty-five Degrees Elevated Upper Body Position | Pain-score on a Verbal Numerical Rating Scale | Vaginal Delivery | 3 units on a scale |
| Forty-five Degrees Elevated Upper Body Position | Pain-score on a Verbal Numerical Rating Scale | Cesarean Section | 4 units on a scale |
Secondary
P-SAP Score
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.
Time frame: 48 hours after delivery
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Non-elevated Upper Body Position | P-SAP Score | Vaginal Delivery | 1 units on a scale |
| Non-elevated Upper Body Position | P-SAP Score | Cesarean Section | 2 units on a scale |
| Forty-five Degrees Elevated Upper Body Position | P-SAP Score | Vaginal Delivery | 1 units on a scale |
| Forty-five Degrees Elevated Upper Body Position | P-SAP Score | Cesarean Section | 2 units on a scale |
Secondary
STOP-BANG Score
The 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.
Time frame: 48 hours after delivery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Non-elevated Upper Body Position | STOP-BANG Score | Vaginal Delivery | 1 units on a scale |
| Non-elevated Upper Body Position | STOP-BANG Score | Cesarean Section | 1 units on a scale |
| Forty-five Degrees Elevated Upper Body Position | STOP-BANG Score | Vaginal Delivery | 1 units on a scale |
| Forty-five Degrees Elevated Upper Body Position | STOP-BANG Score | Cesarean Section | 2 units on a scale |