Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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It is well known that airway management can be difficult during pregnancy. Increased risks for difficult intubation in pregnant women have been often reported. Thus, pregnancy is regarded as a period of high anesthesiologic risk.

Generalized weight gain is a well known factor influencing the upper airway in pregnant women. However, the modifications of the airway itself are less well documented.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave allowing the analysis of the longitudinal cross-sectional area profile of the examined cavity. It is a noninvasive and harmless method.

The aim of the study is to evaluate by acoustic reflection method the physiological modifications of the upper airways during pregnancy.

Women enrolled in the study will undergo an acoustic recording during the first, second, and third trimester of pregnancy, as well as two days and one month after delivery. Forty pregnant women will be included in this monocentric, prospective, open labelled study.

Moreover, a single acoustic recording will be performed in 10 other pregnant women undergoing an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and acoustic method will be compared.

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Detailed Description

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Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Physiological modifications

Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy

Acoustic reflection method

Intervention Type DEVICE

An acoustic reflection device gives the longitudinal cross-sectional area profile along airways. It is based on the analysis of a planar acoustic wave propagating in a rigid duct connected to airway.

MRI and acoustic

Women undergoing an MRI for obstetrical purpose

Acoustic reflection method

Intervention Type DEVICE

An acoustic reflection device gives the longitudinal cross-sectional area profile along airways. It is based on the analysis of a planar acoustic wave propagating in a rigid duct connected to airway.

Interventions

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Acoustic reflection method

An acoustic reflection device gives the longitudinal cross-sectional area profile along airways. It is based on the analysis of a planar acoustic wave propagating in a rigid duct connected to airway.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy will be invited to participate in the study.
* Women are eligible for the study if they are:

* healthy (no previous disease, hypertension, nor obesity),
* 18 years or more
* with a singleton live fetus at the routine ultrasound scan
* with a normal pregnancy.

Exclusion Criteria

* Pregnancy complications
* Multiple pregnancy
* High risk for preterm labor
* Underlying diseases that could interfere with the results (such as pre-existing upper airway problems) and participation.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No