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

NCT02873000 | Unknown DMC

• 1 other identifier: 15-20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the use of Incentive Spirometry in Non-critically Ill Hospitalized Patients With Shortness of Breath.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Forced Vital Capacity (FVC)

  FVC will be measured on admission and at 48 hours

  From admission to the hospital up to 48 hours

Secondary Outcomes (4)

• Subjective perception of respiratory distress

  From admission to the hospital up to 48 hours

• Length of Stay (LOS)

  Starting on admission and until discharge from the hospital (up to 14 days)

• Pulmonary complications

  Starting on admission and continuing for 7 days

• Change in oxygen requirement

  Starting on admission and continuing for 72 hours

Study Arms (2)

Routine Care Group

NO INTERVENTION

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

Experimental Group

EXPERIMENTAL

Intervention 1 (E1): addition of incentive spirometry every hour while awake; There will be a computerized protocol with specific instructions documenting: 1. compliance 2. patient position while using \[sitting up vs laying flat in bed\] 3. inspiratory volume attained 4. effort, motivation and compliance will subjectively be documented using a visual analogue 0-5 point scale.

Behavioral: Incentive Spirometry

Interventions

Incentive Spirometry BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jewish Hospital, Cincinnati, Ohio: lead

Study Sites (1)

Jewish Hospital of Cincinnati

Cincinnati, Ohio, 45236, United States

Location

MeSH Terms

Conditions

Dyspnea; Pneumonia; Pulmonary Disease, Chronic Obstructive; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Imran Naqvi, MD

  Jewish Hospital of Cincinnati

  PRINCIPAL INVESTIGATOR

• Nasim Motayar, MD

  Jewish Hospital of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Naqvi, MD

CONTACT

(513) 686-5446

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Hospitalist, Associated Program Director

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: August 19, 2016
• Study Start: April 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)