Mechanical VentilationNCT03031860
Semi-quantitative Cough Strength Score (SCSS)
An observational study of Mechanical Ventilation, run by Assiut University at 1 site in Egypt.
Trial summary
Cough strength score will give true prediction of Extubation outcome Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Semiquantitative Cough Strength Score
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Mechanical Ventilation
- Being tested
- Semiquantitative Cough Strength Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiquantitative Cough Strength ScoreOther
Also called (SCSS)
Evaluate extubation outcome according to degree of evaluated Semiquantitative Cough Strength Score
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 6 hours postextubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Eman M Aziz, Principal investigator, assiut university faculty of nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031860
- Sponsor's protocol ID
- IRB0000871237
- Status last verified
- Jan 2018
- First submitted
- 21 Jan 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
White AC. Long-term mechanical ventilation: management strategies. Respir Care. 2012 Jun;57(6):889-97; discussion 898-9. doi: 10.4187/respcare.01850.
PubMed 22663965
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Semi-quantitative Cough Strength Score as a Strong Predictor for Extubation Outcome in Head Trauma Patients: a Prospective Descriptive Study
- ClinicalTrials.gov ID
- NCT03031860
- Acronym / sponsor ID
- IRB0000871237
- Conditions
- Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cough strength score will give true prediction of Extubation outcome
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semiquantitative Cough Strength ScoreAlso: (SCSS)Evaluate extubation outcome according to degree of evaluated Semiquantitative Cough Strength Score | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Background: PubMed 22663965White AC. Long-term mechanical ventilation: management strategies. Respir Care. 2012 Jun;57(6):889-97; discussion 898-9. doi: 10.4187/respcare.01850.
- Individual participant dataSharing planned: Undecided
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Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During Spontaneous Breathing Trials
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman M Aziz principal investigator
assiut university faculty of nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.