Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

Pregnancy Clinical Trial

— MAVAG  

Official title:

Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087047
• Other study ID #: MAVAG
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: June 11, 2012
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2012
• Source: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
France	Armand Trousseau University Hospital	Paris
France	Hôpital d'Enfants Armand Trousseau	Paris

Sponsors (2)

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

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological modifications during pregnancy and acoustic reflection method	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	6 months	No
Secondary	MRI and acoustic reflection method	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.	6 months	No