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

A Prospective Randomized Trial of Incentive Spirometry in Non-critically Ill Hospitalized Patients With Shortness of Breath

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

Study Overview

• Status: Unknown
• Conditions: Pneumonia; COPD; Dyspnea; CHF; Pulmonary Complication; Atelectasis; PE
• Intervention / Treatment: Behavioral: Incentive Spirometry

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Naqvi, MD; Phone Number: (513) 686-5446

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Jewish Hospital of Cincinnati
      • Contact: Imran Naqvi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Care Group; Routine Care (R): Standard of care therapy based on admitting diagnosis
Experimental: Experimental Group; 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.	Behavioral: Incentive Spirometry; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From admission to the hospital up to 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.	Starting on admission and until discharge from the hospital (up to 14 days)
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.	Starting on admission and continuing for 7 days
Change in oxygen requirement	Measure percentage change in oxygen requirement in each subject in both groups.	Starting on admission and continuing for 72 hours

Collaborators and Investigators

• Sponsor: Jewish Hospital, Cincinnati, Ohio
• Investigators: Principal Investigator: Imran Naqvi, MD, Jewish Hospital of Cincinnati; Principal Investigator: Nasim Motayar, MD, Jewish Hospital of Cincinnati

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: outcome; incentive spirometry; length of stay,; hospital complication; general internal medicine; hospital medicine; non-critically-ill
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Pulmonary Atelectasis; Dyspnea
• Other Study ID Numbers: 15-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No