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临床试验/NCT03770390
NCT03770390已完成不适用

Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年12月16日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Change in: Oxygen pulse (mL O2 / heart beat)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.

详细描述

The secondary objectives are:

  • To measure the quality of life of patients operated on for pectus excavatum
  • Identify and describe post-operative complications
  • Follow-up on the body mass index changes post-surgery
  • Evaluate intraoperative hemodynamic parameters before and after the retrosternal bar is placed non-invasively

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 —（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patient with pectus excavatum
  • •The patient received corrective surgery within four years of enrollment and is scheduled for a follow-up visit --OR-- the patient is scheduled for corrective surgery during the inclusion period
  • •Collection of informed written consent (patient and legal guardian, if applicable)
  • •Obligation of affiliation or beneficiary of a social security programme

排除标准

  • •Impossibility for the patient to participate in his/her next annual follow-up visit
  • •Absence of exercise test data AND respiratory function test data performed during the preoperative check-up
  • •Subject in exclusion period required by another protocol
  • •Pregnant or lactating woman, patient unable to give consent, protected adult, vulnerable persons (according to French Health Code articles L.1121-6, L.1121-7, L.1211-8, L.1211-9)
  • •Subject deprived of liberty by judicial or administrative decision
  • •Participation of the subject in another interventional protocol
  • •Failure to properly inform the patient (e.g. a language barrier)

结局指标

主要结局

Change in: Oxygen pulse (mL O2 / heart beat)

时间窗: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

Recorded during incremental exercise testing.

次要结局

  • Complications(per-op up to expected maximum of 4 years)
  • Change in: Body mass index (kg/m^2)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: The presence/absence of dyspnea during exercise(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Forced expiratory volume in 1 second (liters)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Forced expiratory volume in 1 second (% predicted)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Forced vital capacity (liters)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: The presence/absence of palpitations(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: The presence/absence of psychosocial impact(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Maximum heart rate (bpm)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Residual volume (liters)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: VO2MAX (ml/kg/min)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: VO2MAX (% predicted)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Presence/absence of an anomaly in oxygen pulse(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Ventilatory threshold (% of VO2MAX)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Breathing Reserve (% of maximum voluntary ventilation)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Total lung capacity (% predicted)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Functional residual capacity (liters)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • The SF36 questionnaire(post-op (expected maximum of 4 years))
  • The Body Esteem Scale(post-op (expected maximum of 4 years))
  • Blood pressure (average, mmHg)(during surgery (day 0))
  • Oxygen saturation (SpO2, %)(during surgery (day 0))
  • Indexed systolic ejection volume (ml/beat/m2)(during surgery (day 0))
  • Pulse(during surgery (day 0))
  • Change in: Forced vital capacity (% predicted)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Forced expiratory volume in 1 second (litres) / forced vital capacity (litres)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Residual volume (% predicted)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Total lung capacity (liters)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Functional residual capacity (% predicted)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • Change in: Residual volume / Total lung capacity (liters/liters)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
  • The Rosenberg Self Esteem Scale(post-op (expected maximum of 4 years))
  • Cardiac index (liters/min/m^2)(during surgery (day 0))
  • Variation in ejection volume (%)(during surgery (day 0))
  • Cumulative dose of vasopressors(during surgery (day 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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