- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05126745
Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals
Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals: an Observational Study
Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. It is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. Failure to provide adequate epidural analgesia is commonly caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic into the epidural space, and consequently the quality of analgesia. Previously, X-ray exposure was required to assess catheter position in the epidural space. Recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow Doppler ultrasonography.
The investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow Doppler ultrasound. Women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.
The investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G1X5
- Mount Sinai 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:
- Women who have delivered under epidural analgesia
- Women who have vaginal or caesarean delivery
- Women with the epidural catheter still in place
Exclusion Criteria:
-Women who experience fetal or maternal complications during delivery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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진통을 위해 경막외 마취를 한 환자
진통을 위해 경막외 마취를 한 환자가 참여할 수 있습니다.
연구 절차는 분만 후 경막외 카테터를 제거하기 전에 수행됩니다.
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Doppler ultrasonography
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound
기간: 15 min
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Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound (at insertion level [yes/no], above insertion level [yes/no], below insertion level [yes/no], no visualization of flow in any space).
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15 min
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Level of epidural catheter insertion: questionnaire
기간: 5 min
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The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4
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5 min
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Epidural regimen: questionnaire
기간: 5 min
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Settings for the epidural pump as charted by the anesthesiologist and the nurse.
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5 min
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Maximum upper sensory block to ice: questionnaire
기간: 5 min
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Maximum upper sensory block to ice as charted by the nurse in the electronic charting system
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5 min
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Any anesthetic intervention for patchy or asymmetric block
기간: 5 min
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The anesthetic record will be reviewed for any interventions done.
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5 min
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Number of manual epidural top ups
기간: 5 min
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The number of top ups given by nurses or physicians manually will be recorded from the chart.
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5 min
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Number of PCEA (patient controlled epidural analgesia) boluses delivered
기간: 5 min
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Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.
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5 min
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Duration of epidural analgesia
기간: 5 min
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Time of epidural placement to delivery or placement to top up for caesarean delivery.
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5 min
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Quality of analgesia questionnaire - 1st stage
기간: 5 min
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Quality of analgesia during first stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10 : On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from the start of your epidural until you were fully dilated? |
5 min
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Quality of analgesia questionnaire - 2nd stage
기간: 5 min
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Quality of analgesia during second stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10: On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from you were fully dilated until the delivery of your baby? |
5 min
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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