カプノグラフィーでモニタリングされた患者におけるオピオイド誘発性呼吸抑制の予測

基本情報

NCT ID

NCT02811302

ステータス

完了

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

1,495

治験依頼者名

Medtronic - MITG

概要

PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort. The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)