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Nursing Care for Breathing Discomfort Among Mechanically Ventilated Patients

Primary Purpose

Dyspnea

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Dyspnea

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of nursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

" interventional "

" Control group "

Arm Description

New other than Routine nursing care will be used.

Routine care only will be done for this group

Outcomes

Primary Outcome Measures

Prevalence of breathing discomfort among Mechanically ventilated patients

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

Effect of nursing intervention on patient and ICU

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04019236

First Posted

July 10, 2019

Last Updated

July 15, 2019

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04019236

Brief Title

Nursing Care for Breathing Discomfort Among Mechanically Ventilated Patients

Official Title

Effect of Implementing Nursing Care on Breathing Discomfort and Its Outcomes Among Mechanically Ventilated Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 18, 2018 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspnea

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

Researcher will provide patients with suitable care for relieving dyspnea and record the outcomes

Masking

Participant

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

" interventional "

Arm Type

Other

Arm Description

New other than Routine nursing care will be used.

Arm Title

" Control group "

Arm Type

No Intervention

Arm Description

Routine care only will be done for this group

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Prevalence of breathing discomfort among Mechanically ventilated patients

Description

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

Time Frame

1year

Title

Effect of nursing intervention on patient and ICU

Description

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

Time Frame

1year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eman Mamdouh Aziz, assit.lecturer

Phone

01286512550

emanmamdouh@aun.edu.eg

Facility Information:

Facility Name

Faculty of nursing

City

Assiut

ZIP/Postal Code

71515

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mervat Anwer Abd El Aziz, Assist.professor

Phone

01062384501

anwerabdelziz@yahoo.com

First Name & Middle Initial & Last Name & Degree

mona Aly Mohamed, Assist.professor

Phone

01226164645

mona@aun.edu.eg

12. IPD Sharing Statement

Citations:

PubMed Identifier

26259140

Citation

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.

Results Reference

background

PubMed Identifier

30391404

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.

Results Reference

background

PubMed Identifier

24275901

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. 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.

Results Reference

background

PubMed Identifier

29107308

Citation

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.

Results Reference

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Nursing Care for Breathing Discomfort Among Mechanically Ventilated Patients

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