Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

NCT01087047 | Completed DMC

• 1 other identifier: MAVAG
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy

Keywords

Pregnancy; Upper airways; Acoustic reflection method

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• MRI and acoustic reflection method

  6 months

Study Arms (2)

Physiological modifications

Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy

Device: Acoustic reflection method

MRI and acoustic

Women undergoing an MRI for obstetrical purpose

Device: Acoustic reflection method

Interventions

Acoustic reflection method DEVICE

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; Physiological modifications

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy pregnant women

You may qualify if:

• 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),
• years or more
• with a singleton live fetus at the routine ultrasound scan
• with a normal pregnancy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Armand Trousseau University Hospital

Paris, 75012, France

Location

Hôpital d'Enfants Armand Trousseau

Paris, 75012, France

Location

Related 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.

  PMID: 18292672 BACKGROUND

• 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.

  PMID: 11160063 BACKGROUND

Study Officials

• Brigitte FAUROUX, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Nicolas LEBOULANGER, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 15, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

FR (2)