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临床试验/NCT06101030
NCT06101030招募中不适用

Comparing Post Operative Utilization of Incentive Spirometry With and Without Electronic Patient Reminder

Tidal Medical Technologies2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
2
主要终点
Number of successful inspiratory breaths attempts per day.

研究概览

简要总结

This study is designed to determine if patients using an incentive spirometer with visual and auditory signals will increase their use of the incentive spirometer and prevent lung complications.

详细描述

The purpose of this study is to determine if the frequency of patients' use of physician ordered incentive spirometry increases with visual and auditory electronic encouragement (signals) compared to the no signal cohort.

Secondarily this study will correlate short term outcomes of study patients to known short term outcome data from the study site and published data to determine if there is a relationship between frequency of use and positive or outcomes or complications, as cited by peer reviewed literature.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • •Patients must meet all the following Inclusion criteria to be eligible for participation in the study:
  • •Patient has undergone a qualifying surgical procedure.
  • •Patient is aged 18 years or over.
  • •Patient has incentive spirometry ordered or incentive spirometry must be part of the study site's standard of care which is implemented by hospital staff.
  • •Patient is able to comply with all study required incentive spirometry instructions.
  • •Patient is without severe hearing or impaired visual acuity deficiency such that they cannot hear or see the audible and visual signal for the InSee monitor.

排除标准

  • •Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation:
  • •Vulnerable Populations (Pregnant, minors, prisoners, those with significantly reduced mental acuity).
  • •Patients where incentive spirometry is inappropriate (patients with Tractotomy, patients who are hemodynamically unstable, patients in reverse isolation due to infection).
  • •Patients with a history of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction), or cognitive issue which would in the opinion of the investigator, make it difficult for the patient to comply with the study procedures or follow the investigators instructions.
  • •Any medical condition that, in the opinion of the investigator, would place the patient at increased risk if they participated.
  • •Any Physician determination that the patient should not participate.

结局指标

主要结局

Number of successful inspiratory breaths attempts per day.

时间窗: through hospitalization an average of 5 days

successful inspiratory breaths is defined as achieving the goal tidal volume

Total number of inspiratory breaths achieved per day.

时间窗: throughout hospitalization an average of 5 days

Inspiratory breaths while using the incentive spirometer

次要结局

  • Change in Inspiratory volume.(throughout hospitalization an average of 5 days)
  • inpatient Pulmonary complication rates.(throughout hospitalization an average of 5 days)
  • Hospital discharge on O2.(throughout hospitalization an average of 5 days)
  • Changes in Inspiratory volume.(throughout hospitalization an average of 5 days)
  • Readmission for pulmonary complication(30 days after discharge)
  • Time to achieve goal tidal volume.(throughout hospitalization an average of 5 days)
  • Change in 02 flow rate.(throughout hospitalization an average of 5 days)
  • Post operative length of O2 use.(throughout hospitalization an average of 5 days)

研究者

发起方
Tidal Medical Technologies
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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