Pulmonary ComplicationNCT02873000
Incentive Spirometry in Non-critically Ill Hospitalized Patients With Acute Respiratory Failure
A study testing Incentive Spirometry in people with Pulmonary Complication and Dyspnea, run by Jewish Hospital, Cincinnati, Ohio at 1 site in United States.
Trial summary
To evaluate the use of Incentive Spirometry in Non-critically Ill Hospitalized Patients With Shortness of Breath. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Pulmonary Complication, Dyspnea, Pneumonia
- What is being tested?
- Incentive Spirometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2017to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients presenting to the ED with chief complaint of "shortness of breath," admitted to the hospitalist service
- Age >65 yrs of age
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Imran Naqvi, MD contact
United States1 site
Jewish Hospital of Cincinnati
Cincinnati, Ohio, 45236
Imran Naqvi, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Complication, Dyspnea, Pneumonia, COPD, CHF, Atelectasis
- Being tested
- Incentive Spirometry
- Keywords
- incentive spirometry, outcome, length of stay,, hospital complication, general internal medicine, hospital medicine, non-critically-ill
- Medical subject headings
- Dyspnea, Pneumonia, Pulmonary Disease, Chronic Obstructive, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive SpirometryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Incentive Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Vital Capacity (FVC)
FVC will be measured on admission and at 48 hours
Measured: From admission to the hospital up to 48 hours
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Starting on admission and continuing for 7 days
Change in oxygen requirement
Measure percentage change in oxygen requirement in each subject in both groups.
Measured: Starting on admission and continuing for 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startApr 2017 (estimated)
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish Hospital, Cincinnati, Ohio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imran Naqvi, Jewish Hospital, Cincinnati, Ohio
- Investigators
- Imran Naqvi, MD, Principal investigator, Jewish Hospital of CincinnatiNasim Motayar, MD, Principal investigator, Jewish Hospital of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873000
- Sponsor's protocol ID
- 15-20
- Status last verified
- Apr 2017
- First submitted
- 20 Nov 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Incentive Spirometry in Non-critically Ill Hospitalized Patients With Shortness of Breath
- ClinicalTrials.gov ID
- NCT02873000
- Acronym / sponsor ID
- 15-20
- Conditions
- Pulmonary Complication, Dyspnea, Pneumonia, COPD, CHF, Atelectasis
- Keywords
- incentive spirometry, outcome, length of stay,, hospital complication, general internal medicine, hospital medicine, non-critically-ill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jewish Hospital, Cincinnati, OhioUniversity, hospital or other
- Study start
- Apr 2017 (estimated)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care Group | No intervention | –Routine Care (R): Standard of care therapy based on admitting diagnosis |
| Experimental Group | Experimental | Behavioral: Incentive SpirometryIntervention 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients presenting to the ED with chief complaint of "shortness of breath," admitted to the hospitalist service
- Age >65 yrs of age
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive SpirometryIncentive 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. | Behavioural | Experimental Group |
Primary outcome
Change in Forced Vital Capacity (FVC)
Time frame: From admission to the hospital up to 48 hours
FVC will be measured on admission and at 48 hours
4 secondary outcomes
Subjective perception of respiratory distress
Time frame: From admission to the hospital up to 48 hours
Length of Stay (LOS)
Time frame: Starting on admission and until discharge from the hospital (up to 14 days)
Pulmonary complications
Time frame: Starting on admission and continuing for 7 days
Change in oxygen requirement
Time frame: Starting on admission and continuing for 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Naqvi, MD contact
Imran Naqvi, MD principal investigator
Jewish Hospital of Cincinnati
Nasim Motayar, MD principal investigator
Jewish Hospital of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive Spirometry in people with Pulmonary Complication and Dyspnea, run by Jewish Hospital, Cincinnati, Ohio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Naqvi, MD ((513) 686-5446), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Vital Capacity (FVC) (time frame: From admission to the hospital up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.