NCT03142997

Brief Summary

This is an observational study to compare the effect of spontaneous ventilation versus controlled ventilation on lung atelectasis using lung score measured by lung ultrasound. the study will be conducted in children hospital of Cairo University Hospitals and study population will be : children aged from one to eight years of age. primary outcome will be the lung score measured by lung ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

May 4, 2017

Last Update Submit

December 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Arterial oxygen tension (Pao2)

    10 minutes following induction of general anesthesia

Secondary Outcomes (2)

  • The lung aeration score

    10 minutes following induction of general anesthesia

  • Correlation between lung score and Pao2.

    10 minutes following induction of general anesthesia

Study Arms (2)

group S

anesthetized children on spontaneous ventilation.

Diagnostic Test: Lung ultrasound

group C

anesthetized children on controlled ventilation.

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasoundDIAGNOSTIC_TEST

we will perform lung ultrasound for both groups to calculate lung score.

group Cgroup S

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children undergoing anesthesia for non-major surgical procedures in Cairo Univesity children hospital.

You may qualify if:

  • ASA physical status I-II
  • Children undergoing minor surgeries in supine position.

You may not qualify if:

  • Parents' refusal.
  • Patients with congenital heart disease.
  • Patients with chronic pulmonary disease ( asthma, bronchiectasis, emphysematous disease, etc.,)
  • Patients with respiratory tract infection.
  • Patients with chest wall deformities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Children Hospital "Aborreesh"

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator, Lecturer of anesthesia and intensive care

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

April 20, 2017

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

December 5, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations