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Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method (MAVAG)

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ClinicalTrials.gov Identifier: NCT01087047
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : June 12, 2012
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Study Description
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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.


Condition or disease Intervention/treatment
Pregnancy Device: Acoustic reflection method

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method
Study Start Date : March 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012
Groups and Cohorts
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Group/Cohort Intervention/treatment
Physiological modifications
Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy
 Device: 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.
MRI and acoustic
Women undergoing an MRI for obstetrical purpose
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Physiological modifications during pregnancy and acoustic reflection method [ Time Frame: 6 months ]

    Main 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 Outcome Measures :
  1. MRI and acoustic reflection method [ Time Frame: 6 months ]

    Secondary 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant women
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087047


Locations
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France
Armand Trousseau University Hospital
Paris, France, 75012
Hôpital d'Enfants Armand Trousseau
Paris, France, 75012
Sponsors and Collaborators
Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Study Director: Brigitte FAUROUX, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Nicolas LEBOULANGER, MD Assistance Publique - Hôpitaux de Paris
More Information
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Publications:

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Responsible Party: Dr Nicolas LEBOULANGER, Dr, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
ClinicalTrials.gov Identifier: NCT01087047    
Other Study ID Numbers: MAVAG
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012
Keywords provided by Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau:
Pregnancy
Upper airways
Acoustic reflection method