Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method (MAVAG)
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| First Received Date ICMJE | March 10, 2010 | ||||||||
| Last Updated Date | June 11, 2012 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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:
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01087047 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method | ||||||||
| Official Title ICMJE | Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Healthy pregnant women |
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| Condition ICMJE | Pregnancy | ||||||||
| Intervention ICMJE | 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. |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | March 2012 | ||||||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01087047 | ||||||||
| Other Study ID Numbers ICMJE | MAVAG | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau | ||||||||
| Study Sponsor ICMJE | Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau | ||||||||
| Collaborators ICMJE | Institut National de la Santé Et de la Recherche Médicale, France | ||||||||
| Investigators ICMJE |
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| Information Provided By | Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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