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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01087047
First received: March 10, 2010
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Pregnancy
 Device: Acoustic reflection method

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

Further study details as provided by Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau:

Primary Outcome Measures:
  • Physiological modifications during pregnancy and acoustic reflection method [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • MRI and acoustic reflection method [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 50
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087047

Locations
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
Study Director: Brigitte FAUROUX, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Nicolas LEBOULANGER, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Dr Nicolas LEBOULANGER, Dr, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
ClinicalTrials.gov Identifier: NCT01087047     History of Changes
Other Study ID Numbers: MAVAG
Study First Received: March 10, 2010
Last Updated: June 11, 2012
Health Authority: France: Ministry of Health

Keywords provided by Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau:
Pregnancy
Upper airways
Acoustic reflection method

ClinicalTrials.gov processed this record on June 18, 2013