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Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01087047
Acronym
MAVAG
Enrollment
50
Registered
2010-03-15
Start date
2010-03-31
Completion date
2012-03-31
Last updated
2012-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Pregnancy, Upper airways, Acoustic reflection method

Brief summary

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.

Interventions

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.

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Physiological modifications during pregnancy and acoustic reflection method6 monthsMain aim: 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 1st, 2d, and 3d trimester of pregnancy * two days after delivery * one month after delivery

Secondary

MeasureTime frameDescription
MRI and acoustic reflection method6 monthsSecondary aim: a single acoustic recording will be proposed to 10 pregnant women undergoing an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and acoustic method will be compared.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026