- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01087047
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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
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Paris, 프랑스, 75012
- Hôpital d'Enfants Armand Trousseau
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Paris, 프랑스, 75012
- Armand Trousseau University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Physiological modifications
Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy
|
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
Women undergoing an MRI for obstetrical purpose
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Physiological modifications during pregnancy and acoustic reflection method
기간: 6 months
|
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:
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
MRI and acoustic reflection method
기간: 6 months
|
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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Brigitte Fauroux, MD, PhD, Assistance Publique - Hôpitaux de Paris
- 수석 연구원: Nicolas LEBOULANGER, MD, Assistance Publique - Hôpitaux de Paris
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MAVAG
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