NCT03094299

Brief Summary

This study aims to evaluate the efficacy of ultrasound derived variables in prediction of success of weaning from mechanical ventilation in critically ill patients with abdominal sepsis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 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

First Submitted

Initial submission to the registry

March 15, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

12 months

First QC Date

March 15, 2017

Last Update Submit

March 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic thickening fraction

    (calculated as maximum thickness - minimum thickness / maximum thickness)

    five minutes before spontaneous breathing trial

Secondary Outcomes (6)

  • Diaphragmatic excursion

    five minutes before spontaneous breathing trial and five minutes before patient extubation

  • Rapid shallow breathing index (RSBI)

    five minutes before spontaneous breathing trial

  • Arterial blood gases

    five minutes before spontaneous breathing trial and five minutes before patient extubation

  • Number of weaning trials

    during the last 7 days

  • Heart rate

    five minutes before spontaneous breathing trial and five minutes before patient extubation

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients with abdominal sepsis.

You may qualify if:

  • Critically ill patients with abdominal sepsis with history of MV for more than 48 hours

You may not qualify if:

  • Age \< 18 years and surgical dressings over the right lower rib cage which would preclude ultrasound examination will be excluded. Also, patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic dysfunction, diaphragmatic injury, diaphragmatic surgery and patients with neuromuscular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Eltrabili HH, Hasanin AM, Soliman MS, Lotfy AM, Hamimy WI, Mukhtar AM. Evaluation of Diaphragmatic Ultrasound Indices as Predictors of Successful Liberation From Mechanical Ventilation in Subjects With Abdominal Sepsis. Respir Care. 2019 May;64(5):564-569. doi: 10.4187/respcare.06391. Epub 2019 Jan 22.

MeSH Terms

Conditions

Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Ahmed Mukhtar, Professor

    Head of research committee section in anesthesia department

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal investigator, Lecturer of anesthesia and critical care medicine

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 29, 2017

Study Start

April 1, 2017

Primary Completion

March 21, 2018

Study Completion

March 23, 2018

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations