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Идёт набор NCT06101030

Comparing Use of Incentive Spirometry With and Without Reminder

— Наблюдательное Post Operative

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Signal On.
Кому может быть актуально
Состояния в реестре: Post Operative. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Signal On
    InSee monitor patient signals are on.

Первичные конечные точки

  • Number of successful inspiratory breaths attempts per day. [Срок оценки: through hospitalization an average of 5 days]
  • Total number of inspiratory breaths achieved per day. [Срок оценки: throughout hospitalization an average of 5 days]
Вторичные конечные точки (8)
  • Time to achieve goal tidal volume. [Срок оценки: throughout hospitalization an average of 5 days]
  • Post operative length of O2 use. [Срок оценки: throughout hospitalization an average of 5 days]
  • Change in 02 flow rate. [Срок оценки: throughout hospitalization an average of 5 days]
  • inpatient Pulmonary complication rates. [Срок оценки: throughout hospitalization an average of 5 days]
  • Hospital discharge on O2. [Срок оценки: throughout hospitalization an average of 5 days]
  • Changes in Inspiratory volume. [Срок оценки: throughout hospitalization an average of 5 days]
  • Change in Inspiratory volume. [Срок оценки: throughout hospitalization an average of 5 days]
  • Readmission for pulmonary complication [Срок оценки: 30 days after discharge]

Критерии участия

Критерии включения

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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 3 центра
  • Tidal Reseach Site — Silver Spring
  • Tidal Study Site — Rochester
  • Tidal Study Site — New Brunswick

Публикации

  • Eltorai AEM, Baird GL, Eltorai AS, Pangborn J, Antoci V Jr, Cullen HA, Paquette K, Connors K, Barbaria J, Smeals KJ, Agarwal S, Healey TT, Ventetuolo CE, Sellke FW, Daniels AH. Incentive Spirometry Adherence: A National Survey of Provider Perspectives. Respir Care. 2018 May;63(5):532-537. doi: 10.4187/respcare.05882. Epub 2018 Jan 23. PMID 29362219
  • Sweity EM, Alkaissi AA, Othman W, Salahat A. Preoperative incentive spirometry for preventing postoperative pulmonary complications in patients undergoing coronary artery bypass graft surgery: a prospective, randomized controlled trial. J Cardiothorac Surg. 2021 Aug 24;16(1):241. doi: 10.1186/s13019-021-01628-2. PMID 34429138
  • Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22. PMID 34676618

Идентификаторы

NCT: NCT06101030 · InSee 202301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗