Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method (MAVAG)
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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Paris, Frankrike, 75012
- Hôpîtal d'Enfants Armand Trousseau
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Paris, Frankrike, 75012
- Armand Trousseau University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Physiological modifications
Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy
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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.
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MRI and acoustic
Women undergoing an MRI for obstetrical purpose
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Physiological modifications during pregnancy and acoustic reflection method
Tidsram: 6 months
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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:
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6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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MRI and acoustic reflection method
Tidsram: 6 months
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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
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studierektor: Brigitte Fauroux, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Huvudutredare: Nicolas LEBOULANGER, MD, Assistance Publique - Hôpitaux de Paris
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- MAVAG
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