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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03031860
Other study ID # IRB0000871237
Secondary ID
Status Completed
Phase N/A
First received January 21, 2017
Last updated January 4, 2018
Start date September 2016
Est. completion date December 2017

Study information

Verified date January 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cough strength score will give true prediction of Extubation outcome


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Semiquantitative Cough Strength Score
Evaluate extubation outcome according to degree of evaluated Semiquantitative Cough Strength Score

Locations

Country Name City State
Egypt Assiut university faculty of medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

White AC. Long-term mechanical ventilation: management strategies. Respir Care. 2012 Jun;57(6):889-97; discussion 898-9. doi: 10.4187/respcare.01850. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Extubation outcome (success or failure), is the patient reintubate again or not and it's correlation with the level of Cough Strength Score 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
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