DyspneaNCT04019236
Nursing Care for Breathing Discomfort Among Mechanically Ventilated Patients
A study testing visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing care in people with Dyspnea, run by Assiut University at 1 site in Egypt.
Trial summary
Breathing discomfort (dyspnea) during mechanical ventilation in the ICU may complicate care. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dyspnea
- What is being tested?
- visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2018to Dec 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Intubated or tracheostomized patients who were mechanically ventilated for >24 hrs.
- Age : 18-60 yrs
- Patients with Respiratory diseases
- Patients during spontaneous breathing trial
Who cannot join
- • Patients with acidosis, anemia ,drug poisoning,psychogenic disorders or neuro-muscular disorders
- (non invasive ventilation)NIV
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of nursing
Asyut, 71515
Mervat Anwer Abd El Aziz, Assist.professor, 01062384501, anwerabdelziz@yahoo.com
mona Aly Mohamed, Assist.professor, 01226164645, mona@aun.edu.eg
About this study
Official title: Effect of Implementing Nursing Care on Breathing Discomfort and Its Outcomes Among Mechanically Ventilated Patients
Breathing discomfort (dyspnea) during mechanical ventilation in the ICU may complicate care.
Read the detailed description
Patients on ventilators experience a variety of discomforts: symptoms (dyspnea ,fatigue , pain ) ,emotions (depression, anxiety ,panic) and feeling of lack to control .Patients may or may not express this discomfort outwardly with agitation ,restlessness ,grimacing or increase in the vital signs (heart rate ,blood pressure ,breathing frequency).The aim of the present study is to assess the prevalence of dyspnea among mechanically ventilated patients, Describe interventions that may alleviate breathing discomfort and examine its impact on clinical outcomes.
- Conditions
- Dyspnea
- Being tested
- visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing care
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing careOther
Distressed patient will be assessed by visual analogue scale(VAS) or respiratory distress observational scale.Nursing interventions will be done according to its causes as giving supplemental O2 therapy, pharmacologic therapy ,initiating positive pressure ventilation or change Ventilator settings (TV, PEEP, Inspiratory pressure ), Improve inspiratory muscle function by Nutrition, positioning or by minimizing use of steroids , clearing airway by Suctioning, Check O2 saturation level frequently and maintain O2 saturation between 95-100%, ,Raising the HOB (Head of the Bed), high Fowler's ,Give pain medications as prescribed or diuretics as ordered and If thick secretions increase oral fluids intake
| Study group | Role | What they receive |
|---|---|---|
| " interventional " | Other | New other than Routine nursing care will be used. Receives: Other: visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing care |
| " Control group " | No intervention | Routine care only will be done for this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of breathing discomfort among Mechanically ventilated patients
visual analogue scale "VAS" for conscious patients and respiratory observational distress scale "RDOS" for unconscious patients
Measured: 1year
Effect of nursing intervention on patient and ICU
Clinical outcomes "length of stay,type of discharge or other morbidities"
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start18 Dec 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Researcher will provide patients with suitable care for relieving dyspnea and record the outcomes
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mamdouh Aziz soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019236
- Sponsor's protocol ID
- Dyspnea among MV Pts
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Persichini R, Gay F, Schmidt M, Mayaux J, Demoule A, Morelot-Panzini C, Similowski T. Diagnostic Accuracy of Respiratory Distress Observation Scales as Surrogates of Dyspnea Self-report in Intensive Care Unit Patients. Anesthesiology. 2015 Oct;123(4):830-7. doi: 10.1097/ALN.0000000000000805.
PubMed 26259140Zhuang Q, Yang GM, Neo SH, Cheung YB. Validity, Reliability, and Diagnostic Accuracy of the Respiratory Distress Observation Scale for Assessment of Dyspnea in Adult Palliative Care Patients. J Pain Symptom Manage. 2019 Feb;57(2):304-310. doi: 10.1016/j.jpainsymman.2018.10.506. Epub 2018 Nov 2.
PubMed 30391404Puntillo K, Nelson JE, Weissman D, Curtis R, Weiss S, Frontera J, Gabriel M, Hays R, Lustbader D, Mosenthal A, Mulkerin C, Ray D, Bassett R, Boss R, Brasel K, Campbell M. Palliative care in the ICU: relief of pain, dyspnea, and thirst--a report from the IPAL-ICU Advisory Board. Intensive Care Med. 2014 Feb;40(2):235-248. doi: 10.1007/s00134-013-3153-z. Epub 2013 Nov 26.
PubMed 24275901Campbell ML. Dyspnea. Crit Care Nurs Clin North Am. 2017 Dec;29(4):461-470. doi: 10.1016/j.cnc.2017.08.006. Epub 2017 Sep 23.
PubMed 29107308
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implementing Nursing Care on Breathing Discomfort and Its Outcomes Among Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT04019236
- Acronym / sponsor ID
- Dyspnea among MV Pts
- Conditions
- Dyspnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Jul 2019 (actual)
- 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.
Breathing discomfort (dyspnea) during mechanical ventilation in the ICU may complicate care.
Detailed description
Patients on ventilators experience a variety of discomforts: symptoms (dyspnea ,fatigue , pain ) ,emotions (depression, anxiety ,panic) and feeling of lack to control .Patients may or may not express this discomfort outwardly with agitation ,restlessness ,grimacing or increase in the vital signs (heart rate ,blood pressure ,breathing frequency).The aim of the present study is to assess the prevalence of dyspnea among mechanically ventilated patients, Describe interventions that may alleviate breathing discomfort and examine its impact on clinical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Researcher will provide patients with suitable care for relieving dyspnea and record the outcomes
| Arm | Type | Receives |
|---|---|---|
| " interventional " | Other | Other: visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing careNew other than Routine nursing care will be used. |
| " Control group " | No intervention | –Routine care only will be done for this group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Intubated or tracheostomized patients who were mechanically ventilated for >24 hrs.
- Age : 18-60 yrs
- Patients with Respiratory diseases
- Patients during spontaneous breathing trial
Key exclusion criteria (2 listed)
- • Patients with acidosis, anemia ,drug poisoning,psychogenic disorders or neuro-muscular disorders
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 |
|---|---|---|
| visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing careDistressed patient will be assessed by visual analogue scale(VAS) or respiratory distress observational scale.Nursing interventions will be done according to its causes as giving supplemental O2 therapy, pharmacologic therapy ,initiating positive pressure ventilation or change Ventilator settings (TV, PEEP, Inspiratory pressure ), Improve inspiratory muscle function by Nutrition, positioning or by minimizing use of steroids , clearing airway by Suctioning, Check O2 saturation level frequently and maintain O2 saturation between 95-100%, ,Raising the HOB (Head of the Bed), high Fowler's ,Give pain medications as prescribed or diuretics as ordered and If thick secretions increase oral fluids intake | Other | " interventional " |
Primary outcome
Prevalence of breathing discomfort among Mechanically ventilated patients
Time frame: 1year
visual analogue scale "VAS" for conscious patients and respiratory observational distress scale "RDOS" for unconscious patients
Effect of nursing intervention on patient and ICU
Time frame: 1year
Clinical outcomes "length of stay,type of discharge or other morbidities"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 26259140Persichini R, Gay F, Schmidt M, Mayaux J, Demoule A, Morelot-Panzini C, Similowski T. Diagnostic Accuracy of Respiratory Distress Observation Scales as Surrogates of Dyspnea Self-report in Intensive Care Unit Patients. Anesthesiology. 2015 Oct;123(4):830-7. doi: 10.1097/ALN.0000000000000805.
- Background: PubMed 30391404Zhuang Q, Yang GM, Neo SH, Cheung YB. Validity, Reliability, and Diagnostic Accuracy of the Respiratory Distress Observation Scale for Assessment of Dyspnea in Adult Palliative Care Patients. J Pain Symptom Manage. 2019 Feb;57(2):304-310. doi: 10.1016/j.jpainsymman.2018.10.506. Epub 2018 Nov 2.
- Background: PubMed 24275901Puntillo K, Nelson JE, Weissman D, Curtis R, Weiss S, Frontera J, Gabriel M, Hays R, Lustbader D, Mosenthal A, Mulkerin C, Ray D, Bassett R, Boss R, Brasel K, Campbell M. Palliative care in the ICU: relief of pain, dyspnea, and thirst--a report from the IPAL-ICU Advisory Board. Intensive Care Med. 2014 Feb;40(2):235-248. doi: 10.1007/s00134-013-3153-z. Epub 2013 Nov 26.
- Background: PubMed 29107308Campbell ML. Dyspnea. Crit Care Nurs Clin North Am. 2017 Dec;29(4):461-470. doi: 10.1016/j.cnc.2017.08.006. Epub 2017 Sep 23.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing care in people with Dyspnea, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 2 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 17 Jul 2019. 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 Egypt. 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 Eman Mamdouh Aziz, assit.lecturer (01286512550, emanmamdouh@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of breathing discomfort among Mechanically ventilated patients (time frame: 1year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019236, which also lists 4 linked publications.
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 17 Jul 2019.