Clinical trial NCT01087047: Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method
Official title: Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Pregnancy
Upper airways
Acoustic reflection method
Lead sponsor: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2010-03-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women

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.


Eligibility 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.

Primary outcomes:
measure: Physiological modifications during pregnancy and acoustic reflection method
timeFrame: 6 months
Secondary outcomes:
measure: MRI and acoustic reflection method
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Armand Trousseau University Hospital
city: Paris
country: France
facility: Hôpital d'Enfants Armand Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Brigitte FAUROUX, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas LEBOULANGER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kodali BS, Chandrasekhar S, Bulich LN, Topulos GP, Datta S. Airway changes during labor and delivery. Anesthesiology. 2008 Mar;108(3):357-62. doi: 10.1097/ALN.0b013e31816452d3.
citation: Louis B, Fodil R, Jaber S, Pigeot J, Jarreau PH, Lofaso F, Isabey D. Dual assessment of airway area profile and respiratory input impedance from a single transient wave. J Appl Physiol (1985). 2001 Feb;90(2):630-7. doi: 10.1152/jappl.2001.90.2.630.