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临床试验/NCT04411186
NCT04411186已完成不适用

A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Inspiratory Capacity

研究概览

简要总结

The objective of this study is to determine whether the addition of lung protective strategies to existing enhanced recovery after surgery (ERAS) protocols for colorectal surgeries and hepatobiliary surgeries will improve post-operative lung function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All subjects going for scheduled colorectal or hepatobiliary surgery at the MUSC ART hospital who would normally be utilizing the existing ERAS protocols
  • •English speaking
  • •Able to give informed consent
  • •Ages 18 years and older

排除标准

  • •Emergency cases
  • •Pregnant subjects-confirmed by pre-operative urine pregnancy test
  • •Subjects with unique lung pathologies including, but not limited to: advanced pulmonary fibrosis, lung transplantation recipients, end stage COPD, pulmonary Hypertension
  • •Subjects on home O2

研究组 & 干预措施

Standard Enhanced Recovery After Surgery (ERAS) Protocol

Active Comparator

Control for this study will be the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.

干预措施: Standard Enhanced Recovery After Surgery (ERAS) Protocol (Procedure)

ERAS and 5 Lung Protective Interventions

Experimental

The standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. The subject will also receive the following lung protective interventions:

  1. Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height)
  2. Positive end-expiratory pressure (PEEP) 7cm H2O5
  3. Immediately post intubation recruitment breath (30cm water for 30 seconds)
  4. Every 1 hour recruitment breath (30cm water for 30 seconds)
  5. 40% FIO2 initially - titrate up as necessary to maintain SPO2 >94%

干预措施: ERAS and 5 Lung Protective Interventions (Procedure)

结局指标

主要结局

Inspiratory Capacity

时间窗: 2 hours

The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.

次要结局

  • Oxygen Saturation (SPO2) Trends(2 hours)
  • Incidence of Supplemental Oxygen Requirements(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Gutman

Assistant Professor

Medical University of South Carolina

研究点 (1)

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