Tidal VolumeNCT04644458
Use of Ulna Length to Predict Tidal Volume in Adult Egyptians
An observational study of Tidal Volume, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the ability of ulna length to predict accurate protective lung tidal volume in Egyptian people in reference to their standing height. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tidal Volume
- What is being tested?
- Measuring the ulna length using meauring tape
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2020to Jul 2023
- 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 40 years
- All sexes
- Adult
Study population: Adult Egyptian volunteers
Who may be able to join
- Healthy adult Egyptian
Who cannot join
- Deformity or previous surgery in the left arm
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Bahaa M Refaie, MD
About this study
Official title: Use of Ulna Length to Predict Protective Lung Tidal Volume in Adult Egyptians
The aim of the study is to evaluate the ability of ulna length to predict accurate protective lung tidal volume in Egyptian people in reference to their standing height.
Read the detailed description
After approval of local ethical committee and informed consent, one hundred healthy volunteers will be rnrolled in this study. Height of each subject will be measured while standing upright against a wall. Then, the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process. From ulna length, height is estimated as advised by Malnutrition Advisory Group, British Association of Parenteral and Enteral Nutrition. October 2008. Malnutrition Universal Screening Tool.Protective lung tidal volume is calculated as 6 ml/kg predicted body weight (PBW) as follow:
PBW= 50*0.91 (centimetres of height - 152.4) in males and 45.5*0.91(centimetres of height - 152.4) in females.
Each measurement will be performed only once for each subject. Agreement between measurements will be expressed by the Bland-Altman method.
- Conditions
- Tidal Volume
- Being tested
- Measuring the ulna length using meauring tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring the ulna length using meauring tapeOther
the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process.
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective lung tidal volume
Measured: measurement of left ulna while standing for each volunteer throught the study completion, average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start20 Oct 2020
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tidal VolumeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa Mohammed Refaie, Sohag University
- Investigators
- Hosam eldeen M Marie, MD, Study director, Consultant of anesthesia and ICU Elhelal insurance hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644458
- Sponsor's protocol ID
- 1990
- Status last verified
- Sep 2021
- First submitted
- 15 Nov 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ulna Length to Predict Protective Lung Tidal Volume in Adult Egyptians
- ClinicalTrials.gov ID
- NCT04644458
- Acronym / sponsor ID
- 1990
- Conditions
- Tidal Volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 25 Nov 2020 (actual)
- 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.
The aim of the study is to evaluate the ability of ulna length to predict accurate protective lung tidal volume in Egyptian people in reference to their standing height.
Detailed description
After approval of local ethical committee and informed consent, one hundred healthy volunteers will be rnrolled in this study. Height of each subject will be measured while standing upright against a wall. Then, the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process. From ulna length, height is estimated as advised by Malnutrition Advisory Group, British Association of Parenteral and Enteral Nutrition. October 2008. Malnutrition Universal Screening Tool.Protective lung tidal volume is calculated as 6 ml/kg predicted body weight (PBW) as follow:
PBW= 50*0.91 (centimetres of height - 152.4) in males and 45.5*0.91(centimetres of height - 152.4) in females.
Each measurement will be performed only once for each subject. Agreement between measurements will be expressed by the Bland-Altman method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Adult Egyptian volunteers
Key inclusion criteria (1 listed)
- Healthy adult Egyptian
Key exclusion criteria (1 listed)
- Deformity or previous surgery in the left arm
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 |
|---|---|---|
| Measuring the ulna length using meauring tapethe left ulna will be measured with a measure tape from the olecranon to mid point of styloid process. | Other | – |
Primary outcome
Protective lung tidal volume
Time frame: measurement of left ulna while standing for each volunteer throught the study completion, average 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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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.
Hosam eldeen M Marie, MD study director
Consultant of anesthesia and ICU Elhelal insurance hospital
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 Tidal Volume, run by Sohag 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahaa M Refaie, MD (01026887257, bahaarefaay@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protective lung tidal volume (time frame: measurement of left ulna while standing for each volunteer throught the study completion, average 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.