LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-09

Study Completion Date

2019-12-14

Brief Summary

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The purpose of this study is to document how often and how severe are the breathing difficulties that patients suffer, while recovering on a general ward following a serious operation

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Detailed Description

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This is a prospective, 2-center, 2-phase pilot study of post-surgical adult patients on the hospital ward at high risk of developing respiratory and cardiovascular events. Phase I, 70 patients will be 1:1 randomly allocated to Capnostream 20p monitoring system or to PM1000N-RR pulse oximeter monitoring system and the alarms of both devices will be silenced and the screen information blinded, to establish a baseline for the incidence of respiratory events. Phase II, 140 patients will be 1:1 randomly allocated to Capnostream 20p or to PM1000N-RR monitoring but the screen information will be visible at the bedside and through the Vital Sync™ remote patient monitoring system.

Conditions

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Respiratory Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The occurrence of at least one of the following RC markers will be considered as primary endpoint for patients monitored by Capnostream 20p during both study Phases: (1) SpO2 ≤ 90% for ≥ 3 minutes.(2) RR ≤ 8 or ≥ 22 bpm for ≥ 3 minutes. (3) etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes. (4) Apnea episode lasting \> 30 seconds.

The occurrence of at least one of the following RC markers will be considered as primary endpoint for patients monitored by PM1000N-RR during both study Phases:

(1) SpO2 ≤ 90% for ≥ 3 minutes. (2) RR ≤ 8 or ≥ 22 bpm for ≥ 3 minutes.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Caregivers

During the study Phase I, the alarms of both devices will be silenced and the screen information blinded, as is the current clinical practice. During the study Phase II, the screen information will be available and the nursing staff will be instructed to respond to both devices' alarms based on a pre-defined hospital protocol.

Study Groups

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Capnostream 20

Continuous monitoring of CO2

Group Type OTHER

Capnostream 20 monitoring

Intervention Type BEHAVIORAL

Continuous monitoring on a general ward

PM1000N-RR

Continuous monitoring of SpO2

Group Type OTHER

PM1000N-RR monitoring

Intervention Type DEVICE

Continuous monitoring on a general ward

Interventions

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Capnostream 20 monitoring

Continuous monitoring on a general ward

Intervention Type BEHAVIORAL

PM1000N-RR monitoring

Continuous monitoring on a general ward

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Non-cardiac post-surgical patients at high risk of developing respiratory and cardiovascular events (High or intermediate risk for postoperative pulmonary complications).
* Adult age (≥18 year old).
* Patient is able and willing to give informed consent.

Exclusion Criteria

* Expected ward length of stay ≤24 hours.
* Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
* Ventilated or intubated patients.
* Patient is unwilling or unable to comply fully with study procedures due to any disease condition which can raise doubt about compliance
* Patient is a member of a vulnerable population regardless of authorized representative support.
* Patient is participating in another potentially confounding drug or device clinical study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No