Living Donor Liver Transplantation RecipientsNCT01865019
Pressure Controlled Versus Volume Controlled Mechanical Ventilation During Anesthesia for Living Donor Liver Transplantation Recipients
An observational study of Living Donor Liver Transplantation Recipients, run by Mansoura University at 1 site in Egypt.
Trial summary
pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for living donor liver transplantation recipients ,improving postoperative graft function and decreasing postoperative pulmonary complications Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Living Donor Liver Transplantation Recipients
- What is being tested?
- mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2013to Dec 2014
- How long will I take part?
- 7 Days
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: living donor liver transplantation recipients
Who may be able to join
- all living donor liver transplantation recipients scheduled
Who cannot join
- Moderate to severe restrictive pulmonary functions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Gastroenterology center
Al Mansurah, Dakahlia Governorate
Amr M Yassen, Professor, 01001497044 ext. 002, amryassen@hotmail.com
Al-refaey a KANDEEL, MASTER
About this study
pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for living donor liver transplantation recipients ,improving postoperative graft function and decreasing postoperative pulmonary complications
- Being tested
- mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationDevice
| Study group | Role | What they receive |
|---|---|---|
| volume controlled | volume ontrolled ventilation Receives: Device: mechanical ventilation | |
| pressure controlled | pressure controlled ventilation Receives: Device: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen tension
Measured: during intraoperative period
Secondary outcomes (1)
decreased postoperative pulmonary complications
Measured: one week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor Liver Transplantation RecipientsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Yassen, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865019
- Sponsor's protocol ID
- 1981
- Other IDs
- 2013
- Status last verified
- May 2013
- First submitted
- 23 Apr 2013
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Controlled Versus Volume Controlled Mechanical Ventilation During Anesthesia for Living Donor Liver Transplantation Recipients
- ClinicalTrials.gov ID
- NCT01865019
- Acronym / sponsor ID
- 1981
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 30 May 2013 (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.
pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for living donor liver transplantation recipients ,improving postoperative graft function and decreasing postoperative pulmonary complications
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| volume controlled | – | Device: mechanical ventilationvolume ontrolled ventilation |
| pressure controlled | – | Device: mechanical ventilationpressure controlled ventilation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- living donor liver transplantation recipients
Key inclusion criteria (1 listed)
- all living donor liver transplantation recipients scheduled
Key exclusion criteria (1 listed)
- Moderate to severe restrictive pulmonary functions
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 |
|---|---|---|
| mechanical ventilation | Device | pressure controlled, volume controlled |
Primary outcome
oxygen tension
Time frame: during intraoperative period
1 secondary outcome
decreased postoperative pulmonary complications
Time frame: one week postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
Related trials for Living Donor Liver Transplantation Recipients
Not yet recruiting
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.
Chronic Liver Disease
RecruitingObservational study
Longitudinal Follow-up and Health-Related Outcomes in Liver Transplant Recipients and Living Donors
Living Donor Liver Transplantation Recipients, Deceased Donor Liver Transplantation Recipients
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.
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 Living Donor Liver Transplantation Recipients, run by Mansoura 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 30 May 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen tension (time frame: during intraoperative period). 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 30 May 2013.