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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04019236
Other study ID # Dyspnea among MV Pts
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 18, 2018
Est. completion date December 2020

Study information

Verified date July 2019
Source Assiut University
Contact Eman Mamdouh Aziz, assit.lecturer
Phone 01286512550
Email emanmamdouh@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Breathing discomfort (dyspnea) during mechanical ventilation in the ICU may complicate care.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Intubated or tracheostomized patients who were mechanically ventilated for >24 hrs.

- Age : 18-60 yrs

- Patients with Respiratory diseases

- Patients during spontaneous breathing trial

Exclusion Criteria:

- • Patients with acidosis, anemia ,drug poisoning,psychogenic disorders or neuro-muscular disorders

- (non invasive ventilation)NIV

Study Design


Related Conditions & MeSH terms


Intervention

Other:
visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing care
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

Locations

Country Name City State
Egypt Faculty of nursing Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Campbell 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. Review. — View Citation

Persichini R, Gay F, Schmidt M, Mayaux J, Demoule A, Morélot-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. — View Citation

Puntillo 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; Advisory Board of the Improving Palliative Care in the ICU (IPAL-ICU) Project. 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):235-48. doi: 10.1007/s00134-013-3153-z. Epub 2013 Nov 26. Review. — View Citation

Zhuang 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of breathing discomfort among Mechanically ventilated patients visual analogue scale "VAS" for conscious patients and respiratory observational distress scale "RDOS" for unconscious patients 1year
Primary Effect of nursing intervention on patient and ICU Clinical outcomes "length of stay,type of discharge or other morbidities" 1year
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