NCT04019236

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

12 months

First QC Date

July 10, 2019

Last Update Submit

July 15, 2019

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (2)

  • 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

  • Effect of nursing intervention on patient and ICU

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

    1year

Study Arms (2)

" interventional "

OTHER

New other than Routine nursing care will be used.

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

Interventions

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

" interventional "

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Intubated or tracheostomized patients who were mechanically ventilated for \>24 hrs.
  • Age : 18-60 yrs
  • Patients with Respiratory diseases
  • Patients during spontaneous breathing trial

You may not qualify if:

  • Patients with acidosis, anemia ,drug poisoning,psychogenic disorders or neuro-muscular disorders
  • (non invasive ventilation)NIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of nursing

Asyut, 71515, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 26259140BACKGROUND

  • 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.

    PMID: 30391404BACKGROUND

  • 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.

    PMID: 24275901BACKGROUND

  • 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.

    PMID: 29107308BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Eman Mamdouh Aziz, assit.lecturer

CONTACT

01286512550emanmamdouh@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: Researcher will provide patients with suitable care for relieving dyspnea and record the outcomes
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 15, 2019

Study Start

December 18, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations

EG(1)