Perioperative/Postoperative ComplicationsNCT04581226
LUS and Consequences of High FiO2 in Children
An observational study of Perioperative/Postoperative Complications, run by Assiut University at 2 sites in Egypt.
Trial summary
The purpose of this study is 1. to evaluate effect of high FiO2 on the development of intraoperative atelectasis in mechanically ventilated children using LUS. 2. to investigate the correlation between lung consolidation score and patient clinical variables including pulmonary mechanics, Sao2%, ABG, and perioperative… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Lung ultrasound
- How many people
- 33 participants
- Where
- 2 sitesEgypt
- Study dates
- 12 Jan 2021to 1 Dec 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Age of 1-6 years. * ASA physical status (I-II). * Endotracheal intubation and mechanical ventilation. * Elective non-abdominal and non-thoracic surgery * lasting for more than 2 hours.
Who may be able to join
- Age of 1-6 years.
- ASA physical status (I-II).
- Endotracheal intubation and mechanical ventilation.
- Elective non-abdominal and non-thoracic surgery
- lasting for more than 2 hours.
Who cannot join
- ASA classification more than II
- Thoracic or abdominal surgery.
- pre-existing lung disease.
- Pre-operative chest infection or abdominal chest US finding. Any thoracic deformity Patients with cardiac, liver or kidney disease.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut university Pediatric hospital
Asyut, Assiut Governorate, 715715
Hala Abdel-Ghaffar
Asyut, Asyut Governorate, 71515
About this study
Official title: 'Correlation Between Lung Ultrasound Findings and Clinical Consequences of High Intraoperative Inspired Oxygen Fraction During Elective Surgery in Mechanically Ventilated Children''
The purpose of this study is
- to evaluate effect of high FiO2 on the development of intraoperative atelectasis in mechanically ventilated children using LUS.
- to investigate the correlation between lung consolidation score and patient clinical variables including pulmonary mechanics, Sao2%, ABG, and perioperative respiratory complications.
Read the detailed description
The WHO and United States centers for disease control and prevention (CDC) recently recommended the administration of 80% inspired oxygen fraction (Fio2) during and immediately after surgery performed with general anesthesia and endotracheal intubation.
The recommendation was based on some data suggesting that intra-operative high Fio2 reduces incidence of surgical site infections.
The dilemma of applying high or low perioperative FiO2 arises in daily practice of pediatric anesthesia because children are at increased risk of developing hypoxemia due to their physiological characteristics including smaller functional residual capacity and increased metabolic requirement compared with adult.
However, considering that atelectasis occurs in most pediatric patients undergoing general anesthesia, it is important to titrate perioperative level of FiO2 to minimize the risk of developing atelectasis and hypoxemia.
The use of FiO2 80% at induction and emergence, whilst limiting FiO2 to 35% during maintenance of anesthesia, may prevent the occurrence of atelectasis and ensure sufficient oxygenation.
Conversely, the use of FiO2 100% at induction and emergence, which is reduced to FiO2 80% during maintenance of anesthesia, may increase the margin of safety to avoid hypoxemia.
In children, the pulmonary consequences of using high FiO2 during general anesthesia have not been fully characterized over the early perioperative period. LUS has shown reliable sensitivity and specificity for diagnosis of anesthesia-induced atelectasis in children [7]. It can identify children needing a recruitment maneuver to re expand their lung and help optimize ventilator treatment during anesthesia.
Our hypothesis is that clinical data are necessary to validate the lung sonographic findings of atelectasis and negative consequences of administrating high perioperative oxygen concentration.
- Being tested
- Lung ultrasound
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
Also called Lung Sonar
All children will be studied in the supine position. LUS will be performed with the portable device MicroMax (Sonosite, Bothell, Washington, USA) using a linear probe of 6 to 12 MHz. All ultrasound scans will be performed by the same anesthetist, who has experience of more than 30 lung ultrasound scans in pediatric patients. Each hemithorax will be divided into six regions, using three longitudinal lines (parasternal, anterior and posterior axillary) and two axial lines (one above the diaphragm and the other 1 cm above the nipples)
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasound | Sonographic assessments including the lung consolidation score, B-line score and Lung aeration score will be recorded 1min. after intubation, at end of surgery and 2h postoperatively. Receives: Diagnostic Test: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
LUS-consolidation Score
The lung ultrasound consolidation score that is divided into four grades and scored between 0 and 3: (0) no consolidation; (1) minimal juxta-pleural consolidation; (2) small-sized consolidation; and (3) large-sized consolidation. Anesthesia-induced atelectasis will be defined to be significant if any region had a consolidation score of ≥ 2.
Measured: It will be recorded intraoperative to 2hours postoperative.
Secondary outcomes (1)
LUS-B-line Score
Lung ultrasound B-Line score. The degree of B-lines will be assessed by the ''B-lines score'' that is divided into four grades and scored between 0 and 3: (0) fewer than three isolated B-lines; (1) multiple well-defined B-lines; (2) multiple coalescent B-lines; and (3) white lung,
Measured: It will be recorded intraoperative to 2hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start12 Jan 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative/Postoperative ComplicationsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Professor of anesthesia and intensive care.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581226
- Sponsor's protocol ID
- 17101201
- Status last verified
- Jul 2023
- First submitted
- 20 Sep 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Correlation Between Lung Ultrasound Findings and Clinical Consequences of High Intraoperative Inspired Oxygen Fraction During Elective Surgery in Mechanically Ventilated Children''
- ClinicalTrials.gov ID
- NCT04581226
- Acronym / sponsor ID
- 17101201
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 9 Oct 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 purpose of this study is
- to evaluate effect of high FiO2 on the development of intraoperative atelectasis in mechanically ventilated children using LUS.
- to investigate the correlation between lung consolidation score and patient clinical variables including pulmonary mechanics, Sao2%, ABG, and perioperative respiratory complications.
Detailed description
The WHO and United States centers for disease control and prevention (CDC) recently recommended the administration of 80% inspired oxygen fraction (Fio2) during and immediately after surgery performed with general anesthesia and endotracheal intubation.
The recommendation was based on some data suggesting that intra-operative high Fio2 reduces incidence of surgical site infections.
The dilemma of applying high or low perioperative FiO2 arises in daily practice of pediatric anesthesia because children are at increased risk of developing hypoxemia due to their physiological characteristics including smaller functional residual capacity and increased metabolic requirement compared with adult.
However, considering that atelectasis occurs in most pediatric patients undergoing general anesthesia, it is important to titrate perioperative level of FiO2 to minimize the risk of developing atelectasis and hypoxemia.
The use of FiO2 80% at induction and emergence, whilst limiting FiO2 to 35% during maintenance of anesthesia, may prevent the occurrence of atelectasis and ensure sufficient oxygenation.
Conversely, the use of FiO2 100% at induction and emergence, which is reduced to FiO2 80% during maintenance of anesthesia, may increase the margin of safety to avoid hypoxemia.
In children, the pulmonary consequences of using high FiO2 during general anesthesia have not been fully characterized over the early perioperative period. LUS has shown reliable sensitivity and specificity for diagnosis of anesthesia-induced atelectasis in children [7]. It can identify children needing a recruitment maneuver to re expand their lung and help optimize ventilator treatment during anesthesia.
Our hypothesis is that clinical data are necessary to validate the lung sonographic findings of atelectasis and negative consequences of administrating high perioperative oxygen concentration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasound | – | Diagnostic Test: Lung ultrasoundSonographic assessments including the lung consolidation score, B-line score and Lung aeration score will be recorded 1min. after intubation, at end of surgery and 2h postoperatively. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Age of 1-6 years. * ASA physical status (I-II). * Endotracheal intubation and mechanical ventilation. * Elective non-abdominal and non-thoracic surgery * lasting for more than 2 hours.
Key inclusion criteria (5 listed)
- Age of 1-6 years.
- ASA physical status (I-II).
- Endotracheal intubation and mechanical ventilation.
- Elective non-abdominal and non-thoracic surgery
- lasting for more than 2 hours.
Key exclusion criteria (4 listed)
- ASA classification more than II
- Thoracic or abdominal surgery.
- pre-existing lung disease.
- Pre-operative chest infection or abdominal chest US finding. Any thoracic deformity Patients with cardiac, liver or kidney disease.
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 ultrasoundAlso: Lung SonarAll children will be studied in the supine position. LUS will be performed with the portable device MicroMax (Sonosite, Bothell, Washington, USA) using a linear probe of 6 to 12 MHz. All ultrasound scans will be performed by the same anesthetist, who has experience of more than 30 lung ultrasound scans in pediatric patients. Each hemithorax will be divided into six regions, using three longitudinal lines (parasternal, anterior and posterior axillary) and two axial lines (one above the diaphragm and the other 1 cm above the nipples) | Diagnostic test | Lung ultrasound |
Primary outcome
LUS-consolidation Score
Time frame: It will be recorded intraoperative to 2hours postoperative.
The lung ultrasound consolidation score that is divided into four grades and scored between 0 and 3: (0) no consolidation; (1) minimal juxta-pleural consolidation; (2) small-sized consolidation; and (3) large-sized consolidation. Anesthesia-induced atelectasis will be defined to be significant if any region had a consolidation score of ≥ 2.
1 secondary outcome
LUS-B-line Score
Time frame: It will be recorded intraoperative to 2hours postoperative.
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 25 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Hala S Abdel-Ghaffar, MD principal investigator
Professor of anesthesia and intensive care.
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 Perioperative/Postoperative Complications, run by Assiut University 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 5 inclusion and 4 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 25 Jul 2023. 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?
LUS-consolidation Score (time frame: It will be recorded intraoperative to 2hours postoperative.). 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 25 Jul 2023.