NCT04576221

Brief Summary

the study aimed to compare the effect of using NIV with using CPAP mask and stacked breathing exercise and its efficacy on chest expansion and pulmonary functions in pneumonic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

August 31, 2020

Last Update Submit

October 1, 2020

Conditions

Keywords

stacked breathingCPAP maskpneumonia

Outcome Measures

Primary Outcomes (2)

  • change chest expansion to the normal range

    change chest expansion as chest expansion measures will be in the normal range and it is measured by measuring tape in CM before and after the procedure

    for 7 days

  • change pulmonary functions to the normal values

    pulmonary functions will be assessed by bed side pulmonary function test as Schneider's match blowing test .

    for 7 days

Study Arms (2)

stacked breathing group

EXPERIMENTAL

experimental group received staked breathing exercise for 7 days , 3 sessions per day, 7-8 times per session

Device: stacked breathing exercise

CPAP group

EXPERIMENTAL

experimental group received NIV with CPAP mask

Device: NIV by CPAP mask

Interventions

• Breath stacking was done using a "bag" which is a simple device used to give artificial breaths.. * It is best done in a sitting position but can be done reclining or lying flat whichever position is used, try to avoid slouching. If sitting: rest against the back of a chair and keep the shoulders, arms and hands relaxed. * If using the mouthpiece, place the lips tightly around the mouthpiece to create a tight seal.

stacked breathing group

provides pressurized air through a mask to help push air into your lungs and help you breathe

CPAP group

Eligibility Criteria

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

You may qualify if:

  • Age of 18 - 60 years.
  • patients of both genders.
  • patients diagnosed with pneumonia.

You may not qualify if:

  • Orthopedic conditions.
  • Malignant conditions.
  • Cognitive impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, Egypt

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Amal A Mohamed, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: use of two manner of breathing for patients with pneumonia.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

August 31, 2020

First Posted

October 6, 2020

Study Start

January 1, 2020

Primary Completion

August 30, 2020

Study Completion

September 1, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations