- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03031860
Semi-quantitative Cough Strength Score (SCSS)
January 4, 2018 updated by: Abdelrady S Ibrahim, MD, Assiut University
Impact of Semi-quantitative Cough Strength Score as a Strong Predictor for Extubation Outcome in Head Trauma Patients: a Prospective Descriptive Study
Cough strength score will give true prediction of Extubation outcome
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Head trauma patients were evaluated for readiness to be weaned off mechanical ventilation.
If they had completed an Spontaneous Breathing Trial (SBT) before extubation.
To measure Semiquantitative Cough Strength Score (SCSS), the investigator will put the patients at 30° to 45°, measure SCSS, first.
The investigator enhance the patient to cough with as much effort as, when the investigator disconnect the ventilator.
The cough strength was scored from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Assiut University Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The sample of this study include 80 head trauma patients from both sex of critically ill mechanically ventilated patient admitted to trauma Intensive Care Unit (ICU).
Description
Inclusion Criteria:
- The study included 80 adult male and female patients' their ages between 18-65 years admitted to trauma ICU with head trauma, on mechanical ventilation more than 24 hours and was ready to be weaned off from mechanical ventilation after successful spontaneous breathing trial and Glasgow Coma Scale (GCS) score > 8 before extubation
Exclusion Criteria:
• Patients who had undergone tracheostomy before extubation, GCS ≤ 8, chest trauma (ribs fracture and lung contusion) and patients with chronic chest disease (Chronic obstructive pulmonary disease, tuberculosis and cancer lung) were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Extubation outcome (success or failure), is the patient reintubate again or not and it's correlation with the level of Cough Strength Score
Time Frame: within 6 hours postextubation
|
The cough strength was scored from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.
|
within 6 hours postextubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eman M Aziz, Assiut university faculty of nursing
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
January 21, 2017
First Submitted That Met QC Criteria
January 24, 2017
First Posted (Estimate)
January 26, 2017
Study Record Updates
Last Update Posted (Actual)
January 8, 2018
Last Update Submitted That Met QC Criteria
January 4, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- IRB0000871237
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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