CALM Breathing for Respiratory Aspiration

Phase-Based Estimates
1
Effectiveness
1
Safety
New York University Grossman School of Medicine, New York, NY
Respiratory Aspiration+1 More
CALM Breathing - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Respiratory Aspiration

Study Summary

This study is evaluating whether a breathing technique may help reduce anxiety in individuals with chronic obstructive pulmonary disease.

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Eligible Conditions

  • Respiratory Aspiration
  • Chronic Obstructive Pulmonary Disease (COPD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CALM Breathing will improve 2 primary outcomes and 15 secondary outcomes in patients with Respiratory Aspiration. Measurement will happen over the course of 3 months.

3 months
6 mile Walking Distance Score
Acceptability Index
COPD Assessment Test (CAT)
Chronic Respiratory Disease Questionnaire Score
DMQ-CAT Score
End-tidal CO2
Feasibility Index
Forced vital capacity (FVC)
GAD-7 Score
Modified Borg scale Score
Patient-Reported Outcomes Measurement Information System (PROMIS-24).
Perceived Stress Scale Score
Percent of predicted forced expiratory volume in 1 second (FEV1 % predicted)
Physical Activity Scale for the Elderly (PASE)
Pulmonary Rehabilitation Engagement
Ratio of FEV1/FVC
Respiratory Rate (RR)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Wait-List Control
CALM Breathing

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. CALM Breathing is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

CALM Breathing
Behavioral
Wait-List Control
Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months for reporting.

Who is running the study

Principal Investigator
A. R. N.
Annamaria R. Norweg, PhD, OTR
Columbia University

Closest Location

New York University Grossman School of Medicine - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
be adult males or females
have a diagnosis of COPD as defined by FEV1/FVC of < 0.70 on spirometry testing or as shown on a chest computed tomography (CT)
receive standard care of pharmacotherapy with bronchodilators (e.g. long-acting beta-agonists, LABAs, or long-acting muscarinic antagonists, or LAMAs) as prescribed by their physician
are in stable medical condition as determined by pulmonary rehabilitation physician (i.e., not in need of acute higher level of care such as hospitalization)
have dyspnea [as documented in their medical record or based on self-report; e.g., ≥1 on modified Medical Research Council questionnaire (mMRC) dyspnea; or ≥2 dyspnea score on item: "Over the last 4 weeks, I have had shortness of breath: almost every day = 4, several days a week = 3, a few days a month = 2, only with lung/respiratory infections = 1, not at all = 0; or "yes" response of binary presence of dyspnea-related avoidance of activities: "Have you avoided any activities due to shortness of breath?")]
DMQ-CAT dyspnea anxiety score ≤50; or DMQ-CAT activity avoidance ≤50;
VAS dyspnea anxiety scale score of ≥20, administered with 6-minute walk test;
ASI-16: item #10, "It scares me when I become short of breath (at least "some");
require ≤8 hours per day of supplemental oxygen
can maintain oxygen saturation (SaO2) ≥ 90% on room air at rest

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can respiratory aspiration be cured?

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Respiratory aspiration can be cured with early treatment including intravenous steroids, which is extremely effective and minimally toxic. However, aspiration with prolonged symptoms or recurrence is difficult to cure. Aggressive aspiration treatment can also fail because of persistent bacterial infection of the esophageal mucosa and the underlying muscular tunic as well as chronic aspiration of solid food. Therefore, the best approach is to find a solution for all these elements.

Unverified Answer

What causes respiratory aspiration?

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Some of respiratory aspiration may result from factors other than the patient's breathing function. The most common causes of respiratory aspiration relate to diseases or disorders with the tongue and pharynx. Other causes of respiratory aspiration often do not change the patient's breathing status and may be less harmful. Some of this risk can be minimized by a regular exercise program and proper oral care including a proper diet.

Unverified Answer

What are common treatments for respiratory aspiration?

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The majority of patients admitted to the intensive care unit received some treatment of respiration. Most of this was in the form of oxygen supplementation, with a lower use of noninvasive ventilation. Patients who received such treatment had a lower risk of death. Nevertheless, most patients who received noninvasive ventilation were intubated, and a large percentage required tracheal surgery. Findings from a recent study from the study suggest that intensive care unit physicians have underestimated the need for noninvasive ventilation, and their administration should be intensified.

Unverified Answer

What is respiratory aspiration?

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This article presents the various diseases that can cause respiratory aspiration in children and describe the treatment of the disorders which are associated with this complication. The treatment of respiratory aspiration consists of aspiration of the fluid, with the aid of a suction tip or forceps, if necessary. The presence of a nasogastric tube is necessary in most cases, especially when there is a severe inflammatory reaction resulting from the aspiration and when the amount of fluid is very large. A chest X-ray is recommended in all cases of patients with respiratory aspiration.

Unverified Answer

What are the signs of respiratory aspiration?

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The common finding is the inability of a patient to speak, due to obstruction of the throat. Other symptoms include cough, hoarseness, and difficulty in breathing. Sometimes, it is not so easy to detect respiratory aspiration, so the patient can be told to breathe deeply, inhale deeply, and then exhale deeply repeatedly so that they don't pass out. Furthermore, a medical exam should be undertaken to examine the mouth, trachea, diaphragm, and lungs of the patient. If possible, a CT scan should be done of the upper or lower part of the chest to look at the lungs.

Unverified Answer

How many people get respiratory aspiration a year in the United States?

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Asthma was reported in about 40,000 out of 526,000 (7.0%) people during the period studied. Rarer conditions such as aspiration of gastric contents, gastric outlet obstruction, and ingestion of sharp objects were reported much more rarely; in about 300 to 500 per year. The reported incidence of aspiration of gastric contents varies considerably between studies, with estimates ranging from 3.6 to 7.5 per 1000 persons/year for people aged 65 years or more. The incidence of aspiration of gastric contents increases with age, from 0.9 per 1000 persons/ year at age 10 to about 1.0 per 1000 persons/year at age 95 years, or 3.8–4.

Unverified Answer

Who should consider clinical trials for respiratory aspiration?

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To increase the participation of critically ill, ventilator-dependent patients in clinical trials, physicians may need to engage these patients in clinical trials, and clinical trial protocols must be developed to ensure that the patients can benefit from such trials.

Unverified Answer

What is the primary cause of respiratory aspiration?

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In patients admitted for emergency intubation, the most common cause of aspiration was coughing, reported in 64% of patients. The next most common causes were vomiting, reported in 35% of patients; and sedation, reported in 7%. There was almost equal frequency of upper and lower respiratory tract aspiration. When compared to published in-hospital mortality rates of respiratory aspiration, our patient population may have been over-represented.

Unverified Answer

What is the average age someone gets respiratory aspiration?

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There are disparities in the rate of aspirated food and fluid between different age ranges. In children younger than 25 months, food items and fluid items are most commonly aspirated. As this age bracket is the most critically vulnerable, targeted education is needed to reduce risk and improve outcome.

Unverified Answer

How serious can respiratory aspiration be?

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In our experience, patients with recurrent respiratory aspiration have a higher probability of developing aspiration pneumonia, and have a poor outcome despite adequate treatment. Early identification of asphyxiation and the use of prophylactic interventions for aspiration are essential to prevent asphyxiation related complications in patients with recurrent respiratory infection.

Unverified Answer

What are the latest developments in calm breathing for therapeutic use?

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The use of calm breathing as a therapeutic method has been found to reduce anxiety, improve digestion and decrease gastrointestinal symptoms. n\nCaveman is an internationally renowned, brand of calm breathing instrument manufactured in California. Caveman, which is based in New Zealand, is a manufacturer of meditation instruments named, ‘Power Breathing’. \n\nThe Power Breathing Caveman is a brand of calm breathing instrument manufactured by Caveman which features sound, fragrance, and light frequencies. The Breathing Power program was created in 2003 and includes instruments and instruction manuals available to be downloaded at Caveman’s website which cover basic and advanced meditation strategies.

Unverified Answer

Have there been other clinical trials involving calm breathing?

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There are only 2 clinical studies on Calm Breathing published to date. Those studies did not report any long-term outcome data. There is only one long-term study of Calm Breathing in a clinical setting. A randomized, controlled trial with long-term outcome data.

Unverified Answer
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