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Incentive Spirometry in Non-critically Ill Hospitalized Patients With Acute Respiratory Failure

Primary Purpose

Pulmonary Complication, Dyspnea, Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incentive Spirometry
Sponsored by
Jewish Hospital, Cincinnati, Ohio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Complication focused on measuring incentive spirometry, outcome, length of stay,, hospital complication, general internal medicine, hospital medicine, non-critically-ill

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

  • Patients presenting to the ED with chief complaint of "shortness of breath," admitted to the hospitalist service
  • Age >65 yrs of age

Exclusion:

  • Patients who can not follow instructions/use IS device
  • Cognitive impairment (Dementia/delirium/Developmental delay)
  • Heavy sedation
  • Inability to take part in deep breathing due to pain or diaphragmatic dysfunction
  • Suicide or psych watch
  • Patients under isolation
  • ICU admission or care within the last 48 hours
  • Recent hospitalization 30 days.
  • Intubation within the last 60 days
  • Routine care group patients that have IS prescribed to them by the admitting MD
  • Chronic/Home oxygen dependence

Sites / Locations

  • Jewish Hospital of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine Care Group

Experimental Group

Arm Description

Routine Care (R): Standard of care therapy based on admitting diagnosis

Intervention 1 (E1): addition of incentive spirometry every hour while awake; There will be a computerized protocol with specific instructions documenting: compliance patient position while using [sitting up vs laying flat in bed] inspiratory volume attained effort, motivation and compliance will subjectively be documented using a visual analogue 0-5 point scale.

Outcomes

Primary Outcome Measures

Change in Forced Vital Capacity (FVC)
FVC will be measured on admission and at 48 hours

Secondary Outcome Measures

Subjective perception of respiratory distress
Visual analogue scale (score 0-5) will be used to measure patient's subjective perception of respiratory distress on the day of admission, at 24 hours and at 48 hours.
Length of Stay (LOS)
Actual length of stay measured in days from date of admission to discharge will be reported per subject per group.
Pulmonary complications
The total number of complications will be reported for each subject: i) radiographically as defined by the radiologist as new or worsening: atelectasis/consolidation; ii) clinical assessment defined by worsening or new respiratory symptoms (shortness of breath, cough and dyspnea on exertion) and physical examination findings (wheezing, rhonchi, rales, crackles) iii) New BiPAP requirement or emergent intubation.
Change in oxygen requirement
Measure percentage change in oxygen requirement in each subject in both groups.

Full Information

First Posted
November 20, 2015
Last Updated
April 14, 2017
Sponsor
Jewish Hospital, Cincinnati, Ohio
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1. Study Identification

Unique Protocol Identification Number
NCT02873000
Brief Title
Incentive Spirometry in Non-critically Ill Hospitalized Patients With Acute Respiratory Failure
Official Title
A Prospective Randomized Trial of Incentive Spirometry in Non-critically Ill Hospitalized Patients With Shortness of Breath
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish Hospital, Cincinnati, Ohio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the use of Incentive Spirometry in Non-critically Ill Hospitalized Patients With Shortness of Breath.
Detailed Description
In recent years the focus in medicine has shifted towards efficient utilization of resources and improving patient outcomes. Incentive spirometry (IS) is a tool that mimics the natural process of yawning or sighing by allowing the user to take deep breaths in a controlled setting. This is a lung inflating maneuver that has been suggested to decrease the rate of pulmonary complications. The focus of utilization of IS and current studies has been predominantly on the post-operative surgical patient population. The mechanism of pulmonary complications in surgical patients is mixed in etiology possibly related to anesthesia, analgesics, pain and immobility leading to shallow breathing and subsequent atelectasis with concurrent hypoxia and risk of infection. The use of lung expanding maneuvers such as that provided by IS are thought to counteract shallow breathing thereby improving pulmonary outcomes. However, contrary to physiological theory, multiple studies and meta-analysis have failed to demonstrate its efficacy. The results of these studies are in direct conflict with what is expected scientifically. The authors of this paper set out to find the reason for discordant data in existing literature, and found that there have been multiple methodological limitations associated with existing studies; hence, interpretation and recommendations based on current data should be done with caution. The common denominator in repeated criticisms of existing studies is lack of reporting on patient compliance with IS after it is prescribed. This is a major confounder, in clinical experience IS is often observed sitting dormant at patients' bedside. These observations are in synchrony with criticisms reported in literature and raise serious questions about validity of existing data that should be acknowledged. Despite lack of convincing evidence, IS is routinely prescribed by physicians in hospital medicine. IS is a low cost tool, nevertheless, the increasing frequency of its use is accumulating to a larger proportion of health care costs. This calls for further evaluation with a study of higher methodological quality to address the limitations of prior studies. The scope of this study is different than that of existing studies in that it will evaluate the utility of IS in general medical patients. The sub-set of patients that are the focus of this study are those admitted with the chief complaint of "shortness of breath." The disease process in the former group leading to shortness of breath includes fluid over-load such as that in congestive heart failure, or an underlying lung process such as pneumonia, COPD, and/or pulmonary embolism. There is a parallel between mechanism of hypoxia in these patients and surgical patients in that these patients too often have pain and take high doses of analgesics, have shallow monotonous breathing and are immobile for long periods of time. From a physiological standpoint sustained maximal inhalation maneuvers may reverse and prevent progression of atelectasis by maintaining airway patency in all patients with shallow breathing of varying etiology not just the surgical sub-set. In a tertiary center community teaching hospital the effectiveness of IS in general medical wards will be evaluated using a single center randomized clinical trial. The goal is to offer a study that overcomes the limitations of prior studies. Lack of strong evidence based data has led to inconsistencies in practice of physicians leading to higher health care costs. The authors hope to design a study of high methodological quality to assess the effectiveness of IS in medical patients; thereby closing the knowledge gap in evidence based practices that may aid physicians in their decision to utilize IS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Complication, Dyspnea, Pneumonia, COPD, CHF, Atelectasis, PE
Keywords
incentive spirometry, outcome, length of stay,, hospital complication, general internal medicine, hospital medicine, non-critically-ill

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine Care Group
Arm Type
No Intervention
Arm Description
Routine Care (R): Standard of care therapy based on admitting diagnosis
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Intervention 1 (E1): addition of incentive spirometry every hour while awake; There will be a computerized protocol with specific instructions documenting: compliance patient position while using [sitting up vs laying flat in bed] inspiratory volume attained effort, motivation and compliance will subjectively be documented using a visual analogue 0-5 point scale.
Intervention Type
Behavioral
Intervention Name(s)
Incentive Spirometry
Intervention Description
Incentive Spirometer is a tool that allows for deep breathing in a controlled setting while providing the user with visual feedback demonstrating the inspiratory volume of each breath.
Primary Outcome Measure Information:
Title
Change in Forced Vital Capacity (FVC)
Description
FVC will be measured on admission and at 48 hours
Time Frame
From admission to the hospital up to 48 hours
Secondary Outcome Measure Information:
Title
Subjective perception of respiratory distress
Description
Visual analogue scale (score 0-5) will be used to measure patient's subjective perception of respiratory distress on the day of admission, at 24 hours and at 48 hours.
Time Frame
From admission to the hospital up to 48 hours
Title
Length of Stay (LOS)
Description
Actual length of stay measured in days from date of admission to discharge will be reported per subject per group.
Time Frame
Starting on admission and until discharge from the hospital (up to 14 days)
Title
Pulmonary complications
Description
The total number of complications will be reported for each subject: i) radiographically as defined by the radiologist as new or worsening: atelectasis/consolidation; ii) clinical assessment defined by worsening or new respiratory symptoms (shortness of breath, cough and dyspnea on exertion) and physical examination findings (wheezing, rhonchi, rales, crackles) iii) New BiPAP requirement or emergent intubation.
Time Frame
Starting on admission and continuing for 7 days
Title
Change in oxygen requirement
Description
Measure percentage change in oxygen requirement in each subject in both groups.
Time Frame
Starting on admission and continuing for 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Patients presenting to the ED with chief complaint of "shortness of breath," admitted to the hospitalist service Age >65 yrs of age Exclusion: Patients who can not follow instructions/use IS device Cognitive impairment (Dementia/delirium/Developmental delay) Heavy sedation Inability to take part in deep breathing due to pain or diaphragmatic dysfunction Suicide or psych watch Patients under isolation ICU admission or care within the last 48 hours Recent hospitalization 30 days. Intubation within the last 60 days Routine care group patients that have IS prescribed to them by the admitting MD Chronic/Home oxygen dependence
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Naqvi, MD
Phone
(513) 686-5446
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Naqvi, MD
Organizational Affiliation
Jewish Hospital of Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasim Motayar, MD
Organizational Affiliation
Jewish Hospital of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish Hospital of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imran Naqvi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Incentive Spirometry in Non-critically Ill Hospitalized Patients With Acute Respiratory Failure

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