NCT05821998

Brief Summary

Statement of the problem: • Does the thoracic block technique has effect on arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation? Null hyposis there is no effect of thoracic block technique on arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

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

December 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

March 25, 2023

Last Update Submit

July 31, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessment of oxygenation status

    Assessment of change of partial pressure of arterial oxygen which is one value in arterial blood gases test results which calculated by arterial blood gases analyzier and comparing results before and after intervention

    10 days for each participant

  • Assessment of ventilation status

    Assessment of change of partial pressure of carbon dioxide which is one value of arterial blood gases test results and calculated by arterial blood gases analyzier before and after intervention

    10 days for each participant

  • Assessment of dynamic lung compliance

    Assessment of change in lung compliance value during air flow which calculated automatically by mechanical ventilator, we record it before and after intervention

    10 days for each participant

Study Arms (2)

Thoracic block technique and designed chest physical therapy program

EXPERIMENTAL

Manual compression on healthy lung for 20 seconds and rest for 20 seconds, total time 20 minutes and percussion, vibration and modified postural drainage on session time for 35 minutes every day for ten days

Other: Thoracic block technique

Designed chest physical therapy program

ACTIVE COMPARATOR

Percussion, vibration and modified postural drainage for 30 minutes every day for ten days

Other: Designed chest physical therapy program

Interventions

Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation

Also known as: Technique of insufflation to reverse atelectasis
Thoracic block technique and designed chest physical therapy program

Percussion, vibration and modified postural drainage

Designed chest physical therapy program

Eligibility Criteria

Age4 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age range from 4 months to 4 years.
  • diagnosed with pneumonia, receiving mechanical ventilation.
  • start from second day of admission to intensive care unit
  • have unilateral mild to moderate atelectasis according to medical referral.
  • should be vitally stable during the session.

You may not qualify if:

  • The children were excluded from the study if they had one of the following:
  • medically unstable ( examples: tachycardia and tachypnea)
  • uncontrolled convulsion.
  • rib fracture.
  • pneumothorax -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Alaa Abdallah

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific researcher

Study Record Dates

First Submitted

March 25, 2023

First Posted

April 20, 2023

Study Start

December 1, 2022

Primary Completion

May 25, 2023

Study Completion

May 31, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations