Exta Vascular Lung WaterNCT05317897
Utility of Lung Ultrasonography As a Predictor of Fast Track Extubation
An observational study of Exta Vascular Lung Water, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial summary
Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Exta Vascular Lung Water
- What is being tested?
- Lung ultrasound examination
- How many people
- 45 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Sep 2018to 1 Aug 2022
- 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 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients suffering from Acyanotic congenital heart diseases.
Who may be able to join
- were Age 6 months to 7 years
- Patients suffering from Acyanotic congenital heart diseases.
Who cannot join
- Age is less than 6 months and more than 7 years,
- Preoperative mechanical ventilation,
- Preoperative inotropic support.,
- Trisomy 21,
- Patient with cyanotic heart diseases
- Coagulopathy INR >1.5
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Kasr Al Ainy Hospital
Cairo, Cairo Governorate, 11562
Kasr Alainy hospital
Cairo
About this study
Official title: Utility of Lung Ultrasonography As a Predictor of Fast Track Extubation in Pediatric Cardiac Surgeries an Observational Study
Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation.
Read the detailed description
background: Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation.
Methedology: in this prospective, observational study, 45 pediatric patients who will go elective repair of congenital acyanotic heart diseases were included and were examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined Demographic data: Patients' name, age, sex, diagnosis, relevant medical and surgical history. And Assessment data: Baseline arterial blood gases and lung ultrasound score assessment after induction of anesthesia and at the end of surgery.
Primary outcome will be the sensitivity of lung ultrasound scores immediately at the end of pediatric cardiac operation in prediction of extubation. and Secondary outcome will be correlation between lung ultrasound score and Po2/Fio2 ratio at the end of operation
- Conditions
- Exta Vascular Lung Water
- Being tested
- Lung ultrasound examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound examinationDiagnostic test
Also called The lung ultrasound score
45 pediatric patients who will go elective repair of congenital acyanotic heart diseases will be included and will be examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined.
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensitivity of lung ultrasound scores
the sensitivity of lung ultrasound scores immediately at the end of pediatric cardiac operation in prediction of extubation
Measured: immediately at the end of pediatric cardiac operation
Secondary outcomes (1)
correlation between lung ultrasound score and Po2/Fio2 ratio
correlation between lung ultrasound score and Po2/Fio2 ratio at the end of operation
Measured: immediatly at the end of pediatric cardiac operation until 6 hours post operative until extubatiioon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start20 Sep 2018
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exta Vascular Lung WaterStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317897
- Sponsor's protocol ID
- MS-235-2017
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Lung Ultrasonography As a Predictor of Fast Track Extubation in Pediatric Cardiac Surgeries an Observational Study
- ClinicalTrials.gov ID
- NCT05317897
- Acronym / sponsor ID
- MS-235-2017
- Conditions
- Exta Vascular Lung Water
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 8 Apr 2022 (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.
Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation.
Detailed description
background: Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation.
Methedology: in this prospective, observational study, 45 pediatric patients who will go elective repair of congenital acyanotic heart diseases were included and were examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined Demographic data: Patients' name, age, sex, diagnosis, relevant medical and surgical history. And Assessment data: Baseline arterial blood gases and lung ultrasound score assessment after induction of anesthesia and at the end of surgery.
Primary outcome will be the sensitivity of lung ultrasound scores immediately at the end of pediatric cardiac operation in prediction of extubation. and Secondary outcome will be correlation between lung ultrasound score and Po2/Fio2 ratio at the end of operation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients suffering from Acyanotic congenital heart diseases.
Key inclusion criteria (2 listed)
- were Age 6 months to 7 years
- Patients suffering from Acyanotic congenital heart diseases.
Key exclusion criteria (6 listed)
- Age is less than 6 months and more than 7 years,
- Preoperative mechanical ventilation,
- Preoperative inotropic support.,
- Trisomy 21,
- Patient with cyanotic heart diseases
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 |
|---|---|---|
| Lung ultrasound examinationAlso: The lung ultrasound score45 pediatric patients who will go elective repair of congenital acyanotic heart diseases will be included and will be examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined. | Diagnostic test | – |
Primary outcome
the sensitivity of lung ultrasound scores
Time frame: immediately at the end of pediatric cardiac operation
the sensitivity of lung ultrasound scores immediately at the end of pediatric cardiac operation in prediction of extubation
1 secondary outcome
correlation between lung ultrasound score and Po2/Fio2 ratio
Time frame: immediatly at the end of pediatric cardiac operation until 6 hours post operative until extubatiioon
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 17 Jan 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exta Vascular Lung Water, run by Kasr El Aini Hospital at 2 sites 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 2 inclusion and 6 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
the sensitivity of lung ultrasound scores (time frame: immediately at the end of pediatric cardiac operation). 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 17 Jan 2025.