Intraoperative ComplicationsRMNCT03557905
Ultrasonographic Assessment of Lung Recruitment Maneuvers in Children Undergoing Lengthy Microsurgery Operations
A study testing RM 0.5 and RM 0.3 in people with Intraoperative Complications, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study will be to explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Intraoperative Complications
- What is being tested?
- RM 0.5 and RM 0.3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Aug 2018to 30 Jan 2023
- Phase
- Interventional
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2-12 years old.
- ASA physical status classification I-II.
- Undergoing lengthy microsurgery operations
- and requiring endotracheal intubation and mechanical ventilation for more than 4 hours.-
Who cannot join
- ASA Physical status classification >II.
- Thoracic or abdominal surgery.
- Preexisting lung disease.
- Pre-operative chest infection or abnormal chest US findings.
- Cardiac patients.-
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university main hospital, Microsurgery unit
Asyut, Assiut Governorate, 715715
About this study
Official title: Ultrasonographic Assessment of Lung Recruitment Maneuvers in Pediatric Patients Undergoing Lengthy Microsurgery Operations
The aim of this study will be to explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative FIO2 (0.5 VERSUS 0.3).
Read the detailed description
- To maximize the benefits, minimize the drawbacks and assess the adequacy of the recruitment maneuver; adequate monitoring at the bedside is essential. Several methods have been proposed, including measuring end-expiratory lung volume or pulmonary compliance, volumetric capnography, oxygenation indices, electrical impedance tomography, computerized tomography and lung ultrasound.
- For lung CT examination patients must be transported out to the radiation unit, which carries risk of transfer, high cost, and radiation exposure. The oxygenation method which is the most commonly used, but it is necessary to repeat arterial blood collection many times, which is cumbersome and expensive.
- Using lung ultrasound (LUS) as real-time guidance during the recruitment maneuver has gained popularity recently owing to its' easy applicability and non-invasive nature. Sonography is a radiation-free methodology which plays an important role in diagnosing pulmonary diseases in children, including obstructive and compressive atelectasis of different origins. Furthermore, lung ultrasound has shown reliable sensitivity and specificity for the diagnosis of anaesthesia-induced atelectasis in children.
- LUS can identify children needing a recruitment maneuver to re-expand their lungs and help optimize ventilator treatment during anesthesia.
- Conditions
- Intraoperative Complications
- Being tested
- RM 0.5, RM 0.3
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RM 0.5Device
Also called RM
Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse.
RM 0.3Device
Also called RM
The patient will be ventilated with volume control mode with tidal volume 6 ml/kg, PEEP 3 cmH2O, an inspiratory expiratory ratio of 1:1.5, respiratory rate 20-25 breaths per minute depending on the patient's age and FiO2 of 0.3.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.5. . Receives: Device: RM 0.5 |
| Group II | Active comparator | Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.3. Receives: Device: RM 0.3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Areation Score
lung Areation Score calculated on first lung ultrasound.For a given thoracic area, points will be allocated to the worst LUS pattern observed and video clips of each region examined will be stored. The sum of the points obtained in all the 12 lung areas will define the LUS aeration score, ranging from 0 to 36 for the whole thorax. This score is inversely proportional to the degree of lung aeration.
Measured: 10 minutes after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start6 Aug 2018
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative FIO2 (0.5 VERSUS 0.3).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 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 Abdelghaffar, MD, Principal investigator, Professor of anesthesia, faculty of medicine, Assiut university, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557905
- Sponsor's protocol ID
- 17200202
- Acronym
- RM
- Status last verified
- Jul 2023
- First submitted
- 5 Jun 2018
- 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
- Ultrasonographic Assessment of Lung Recruitment Maneuvers in Pediatric Patients Undergoing Lengthy Microsurgery Operations
- ClinicalTrials.gov ID
- NCT03557905
- Acronym / sponsor ID
- RM / 17200202
- Conditions
- Intraoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 15 Jun 2018 (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 this study will be to explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative FIO2 (0.5 VERSUS 0.3).
Detailed description
- To maximize the benefits, minimize the drawbacks and assess the adequacy of the recruitment maneuver; adequate monitoring at the bedside is essential. Several methods have been proposed, including measuring end-expiratory lung volume or pulmonary compliance, volumetric capnography, oxygenation indices, electrical impedance tomography, computerized tomography and lung ultrasound.
- For lung CT examination patients must be transported out to the radiation unit, which carries risk of transfer, high cost, and radiation exposure. The oxygenation method which is the most commonly used, but it is necessary to repeat arterial blood collection many times, which is cumbersome and expensive.
- Using lung ultrasound (LUS) as real-time guidance during the recruitment maneuver has gained popularity recently owing to its' easy applicability and non-invasive nature. Sonography is a radiation-free methodology which plays an important role in diagnosing pulmonary diseases in children, including obstructive and compressive atelectasis of different origins. Furthermore, lung ultrasound has shown reliable sensitivity and specificity for the diagnosis of anaesthesia-induced atelectasis in children.
- LUS can identify children needing a recruitment maneuver to re-expand their lungs and help optimize ventilator treatment during anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- To explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative FIO2 (0.5 VERSUS 0.3).
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: RM 0.5Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.5. . |
| Group II | Active comparator | Device: RM 0.3Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.3. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 2-12 years old.
- ASA physical status classification I-II.
- Undergoing lengthy microsurgery operations
- and requiring endotracheal intubation and mechanical ventilation for more than 4 hours.-
Key exclusion criteria (5 listed)
- ASA Physical status classification >II.
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 |
|---|---|---|
| RM 0.5Also: RMPatients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse. | Device | Group I |
| RM 0.3Also: RMThe patient will be ventilated with volume control mode with tidal volume 6 ml/kg, PEEP 3 cmH2O, an inspiratory expiratory ratio of 1:1.5, respiratory rate 20-25 breaths per minute depending on the patient's age and FiO2 of 0.3. | Device | Group II |
Primary outcome
Lung Areation Score
Time frame: 10 minutes after induction of anesthesia
lung Areation Score calculated on first lung ultrasound.For a given thoracic area, points will be allocated to the worst LUS pattern observed and video clips of each region examined will be stored. The sum of the points obtained in all the 12 lung areas will define the LUS aeration score, ranging from 0 to 36 for the whole thorax. This score is inversely proportional to the degree of lung aeration.
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 Abdelghaffar, MD principal investigator
Professor of anesthesia, faculty of medicine, Assiut university, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RM 0.5 and RM 0.3 in people with Intraoperative Complications, 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 4 inclusion and 5 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 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?
Lung Areation Score (time frame: 10 minutes after induction of anesthesia). 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; AzTrials last refreshed its copy on 8 Nov 2026.