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Status unknownNCT04019236Updated Jul 17, 2019

Nursing Care for Breathing Discomfort Among Mechanically Ventilated Patients

An interventional study of visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing care in Dyspnea, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-17.

Sponsored by Assiut University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Dec 2018, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Dyspnea

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03

In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's planned enrollment of 90 is above the median of 48 across 430 interventional studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

      • (non invasive ventilation)NIV
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • Other
    " interventional "

    New other than Routine nursing care will be used.

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

  • No intervention
    " Control group "

    Routine care only will be done for this group

Interventions

  • Othervisual 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

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What researchers measure

Primary outcomes

  1. Prevalence of breathing discomfort among Mechanically ventilated patients

    visual analogue scale "VAS" for conscious patients and respiratory observational distress scale "RDOS" for unconscious patients

    Time frame: 1year

  2. Effect of nursing intervention on patient and ICU

    Clinical outcomes "length of stay,type of discharge or other morbidities"

    Time frame: 1year

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Study locations

1 of 1 sites recruiting
  • Faculty of nursing
    Assiut, 71515, Egypt
    Recruiting
08

References and documents

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 26259140 ↗
  • 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. PubMed 30391404 ↗
  • 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. 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 24275901 ↗
  • 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. PubMed 29107308 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04019236
Lead sponsor
Assiut University
Responsible party
Eman Mamdouh Aziz soliman (Principal Investigator, Assiut University) — Principal investigator
First posted
Jul 15, 2019
Start date
Dec 18, 2018
Primary completion
Dec 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jul 17, 2019

Study contacts

Eman Mamdouh Aziz, assit.lecturer
Contact
emanmamdouh@aun.edu.eg
01286512550

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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