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Determination of the Predictors of Nocturnal Desaturation in Postpartum Women

Primary Purpose

Sleep Disordered Breathing, Nocturnal Oxygen Desaturation, Upper Airway Edema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Forty-five degrees elevated upper body position
non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150)
Stop-Bang questionnaire
Epworth Sleepiness Scale
P-SAP Score
self-reported pain
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disordered Breathing

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Forty-five degrees elevated upper body position

Non-elevated upper body position

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

SpO2 < 90%
Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery

Secondary Outcome Measures

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.
Minimal & Mean SpO2
Basic pulseoximetry in the first night after delivery
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.
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.
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.
Average Pulse Rate
As measured in beats per minute

Full Information

First Posted
December 23, 2014
Last Updated
June 8, 2018
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02330055
Brief Title
Determination of the Predictors of Nocturnal Desaturation in Postpartum Women
Official Title
Determination of the Predictors of Nocturnal Desaturation in Postpartum Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing, Nocturnal Oxygen Desaturation, Upper Airway Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forty-five degrees elevated upper body position
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-elevated upper body position
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Forty-five degrees elevated upper body position
Intervention Type
Procedure
Intervention Name(s)
non-elevated upper body position
Intervention Type
Device
Intervention Name(s)
Noninvasive wrist pulse oximeter (WristOx Model 3150)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stop-Bang questionnaire
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Epworth Sleepiness Scale
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
P-SAP Score
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
self-reported pain
Intervention Description
A verbal numerical rating scale is used to asses the pain during the study-night.
Primary Outcome Measure Information:
Title
SpO2 < 90%
Description
Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery
Time Frame
48 hours after delivery
Secondary Outcome Measure Information:
Title
Oxygen Desaturation Index > 3
Description
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
Title
Minimal & Mean SpO2
Description
Basic pulseoximetry in the first night after delivery
Time Frame
48 hours after delivery
Title
P-SAP Score
Description
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
Title
STOP-BANG Score
Description
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
Title
Pain-score on a Verbal Numerical Rating Scale
Description
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
Title
Average Pulse Rate
Description
As measured in beats per minute
Time Frame
48 Hours after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Eikermann, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Determination of the Predictors of Nocturnal Desaturation in Postpartum Women

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