Pediatric Lung AtelectasisNCT06188169
Effectiveness of Ultrasound-guided Lung Ventilation in Determining the Optimum Inspiratory Pressure in Pediatric Patients
A study testing Increasing the inspiratory pressure if atelectasis detected by US in people with Pediatric Lung Atelectasis, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to show the Effectiveness of Ultrasound-guided Lung Ventilation to determine the appropriate level of inspiratory pressure sufficient to provide adequate pulmonary ventilation with the resolution of the atelectatic lung. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Lung Atelectasis
- What is being tested?
- Increasing the inspiratory pressure if atelectasis detected by US
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2022to 12 Aug 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children's age starting from 5 to 12 years.
- Genders eligible for the study: both sexes.
- ASA I-II.
- They were scheduled for elective Abdomino-pelvic surgery lasting > 1.5 hours duration.
Who cannot join
- Parent refusal
- Emergency cases
- Laparoscopic surgeries
- Acute respiratory disease, pulmonary or lung diseases
- Lung consolidation score ≥ 2 before intubation
- Morbid obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ultrasound-guided Lung Ventilation in Determining the Optimum Inspiratory Pressure in Pediatric Patients Undergoing Abdomino-pelvic Surgeries ; a Randomized Controlled Study
This study aimed to show the Effectiveness of Ultrasound-guided Lung Ventilation to determine the appropriate level of inspiratory pressure sufficient to provide adequate pulmonary ventilation with the resolution of the atelectatic lung.
Read the detailed description
Respiratory physiology is different in young children, especially in neonates and infants, from that of older children and adults. Neonates and infants have immature respiratory control, weak respiratory muscles, different airways, lung mechanics and higher basal metabolic oxygen requirements. Appreciating these distinctive respiratory characteristics in young children is necessary to formulate suitable anesthetic plans for the safe conduct of anesthesia as respiratory-related morbidity and mortality occur even in healthy children.
Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages. The reported incidence of anesthesia-induced atelectasis in children varies from 12 to 42% in sedated and non-intubated patients and from 68 to 100% in children with general anesthesia with tracheal intubation or laryngeal mask.
Such lung collapse causes arterial blood oxygenation to decline during and after anesthesia. Although anesthesia-induced atelectasis resolves spontaneously in children with American Society of Anesthesiology's (ASA) physical status classification I to II after minor surgical procedures, this entity may persist in the postoperative period in high-risk children undergoing complex surgeries. In the latter population, atelectasis potentially increases the risk for ventilator-induced lung injury and could be associated with postoperative pulmonary complications.
Atelectasis and poorly ventilated lung areas appear during general anesthesia in adults as well as in children. It is of concern that collapsed lung tissue reduces lung compliance and causes venous admixture and arterial oxygenation impairment. Despite its high prevalence during anesthesia, bedside diagnosis of atelectasis remains challenging. Anesthesia-induced atelectasis is commonly small and thus mostly invisible on standard chest radiographs. In contrast, it can easily be diagnosed by tomographic imaging techniques such as computed tomography or magnetic resonance imaging (MRI). However, these latter are clinically impractical, expensive, time-consuming, and with harmful exposition to x-ray.
Sonography is a simple, non-invasive, and radiation-free methodology that has increased daily practice usage. Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children, including obstructive and compressive atelectasis of different origins. Just as in adults, LUS could identify children needing a recruitment maneuver to re-expand their lungs and help optimize ventilator treatment during anesthesia. LUS could also identify critically ill children with a high risk for developing pulmonary complications due to residual atelectasis after surgery.
A prospective, randomized, double-blind study in the Second Affiliated Hospital and Yuying Children Hospital of Wenzhou Medical University showed that an inspiratory pressure of 12 cm H2O was sufficient to provide adequate ventilation with a lower occurrence of gastric insufflation during induction of general anesthesia in paralyzed Chinese children aged from 2 to 4 years old.
Many studies used LUS to determine the optimum positive end-expiratory pressure (PEEP), yet no previous studies used LUS to determine the best inspiratory pressure (IP) for pressure controlled ventilation. So, this study aimed to determine the appropriate level of inspiratory pressure sufficient to provide adequate pulmonary ventilation with the resolution of anesthesia-induced lung atelectasis using real-time ultrasonography in paralyzed children.
- Conditions
- Pediatric Lung Atelectasis
- Being tested
- Increasing the inspiratory pressure if atelectasis detected by US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing the inspiratory pressure if atelectasis detected by USProcedure or surgery
The study used US to detect presence of lung atelectasis under mechanical ventilation in pediatrics. Inspiratory pressure increased gradually with continuous monitoring by lung US to minimize the atelectasis as possible.
| Study group | Role | What they receive |
|---|---|---|
| Group A = C-PCV received conventional pressure-controlled ventilation | Experimental | Inspiratory pressure will be adjusted to achieve an expired tidal volume of 7 ml/Kg; the respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H2O, and FiO2 at 0.5. No further adjustment in IP will be made throughout the surgery. LUS will be performed at the same fixed four-time interval as Group-B. Anesthesiologist will not do any interventions to the atelectatic areas in this group. Receives: Procedure: Increasing the inspiratory pressure if atelectasis detected by US |
| Group B = US-PCV: received ultrasound-guided pressure-controlled ventilation | Active comparator | Initial IP will be ten cmH2O, PEEP 4 cmH2O with a 0.5 inspired oxygen fraction, and RR 12 breaths/min. Then under ultrasound guidance, a stepwise increase in inspiratory pressure from 10 cmH2O by 2 cmH2O increments every 5 min until the atelectasis disappeared on ultrasound (progression from lung collapse to B lines to normal lung image). The IP will be fixed at this level, and RR will be adjusted to maintain an EtCO2 at 32-35 mmHg. The maximum airway pressure will be limited to 35 cmH2O. Receives: Procedure: Increasing the inspiratory pressure if atelectasis detected by US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of significant anesthesia-induced lung collapse diagnosed by LUS examined at T2.
Significant lung atelectasis will be defined as any region that had a lung consolidation score of ≥2.
Measured: 1 minute after skin closure and before extubation (T2)
Secondary outcomes (2)
Time in minutes to resumption of normal lung aeration in the consolidated area started from diagnosis of collapse (T1) until lung consolidation score < 2 in group US-PCV
Measured: "from diagnosis of collapse until lung consolidation score < 2 in group US-PCV (assessed up to 5 minutes)"
Incidence of lung collapse in the two groups as detected by lung US at the 3rd formal lung ultrasound examination (T2).
Measured: 1 minute after skin closure and before extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start15 Oct 2022
- Primary completion5 Jun 2023
- Study completion12 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Lung AtelectasisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a comparative prospective randomized controlled study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Yahia El Sayed Kamel, Cairo University
- Investigators
- Sherif Soaida, MD, Study director, Cairo UniversityHany Mohammed, MD, Study director, Cairo UniversityMohamed Mohamed, MD, Study director, Cairo UniversityOmnia Kamel, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188169
- Sponsor's protocol ID
- US-guided Lung ventilation
- Status last verified
- Dec 2023
- First submitted
- 29 Oct 2023
- Last updated
- 3 Jan 2024
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound-guided Lung Ventilation in Determining the Optimum Inspiratory Pressure in Pediatric Patients Undergoing Abdomino-pelvic Surgeries ; a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06188169
- Acronym / sponsor ID
- US-guided Lung ventilation
- Conditions
- Pediatric Lung Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 12 Aug 2023 (actual)
- First posted
- 3 Jan 2024 (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.
This study aimed to show the Effectiveness of Ultrasound-guided Lung Ventilation to determine the appropriate level of inspiratory pressure sufficient to provide adequate pulmonary ventilation with the resolution of the atelectatic lung.
Detailed description
Respiratory physiology is different in young children, especially in neonates and infants, from that of older children and adults. Neonates and infants have immature respiratory control, weak respiratory muscles, different airways, lung mechanics and higher basal metabolic oxygen requirements. Appreciating these distinctive respiratory characteristics in young children is necessary to formulate suitable anesthetic plans for the safe conduct of anesthesia as respiratory-related morbidity and mortality occur even in healthy children.
Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages. The reported incidence of anesthesia-induced atelectasis in children varies from 12 to 42% in sedated and non-intubated patients and from 68 to 100% in children with general anesthesia with tracheal intubation or laryngeal mask.
Such lung collapse causes arterial blood oxygenation to decline during and after anesthesia. Although anesthesia-induced atelectasis resolves spontaneously in children with American Society of Anesthesiology's (ASA) physical status classification I to II after minor surgical procedures, this entity may persist in the postoperative period in high-risk children undergoing complex surgeries. In the latter population, atelectasis potentially increases the risk for ventilator-induced lung injury and could be associated with postoperative pulmonary complications.
Atelectasis and poorly ventilated lung areas appear during general anesthesia in adults as well as in children. It is of concern that collapsed lung tissue reduces lung compliance and causes venous admixture and arterial oxygenation impairment. Despite its high prevalence during anesthesia, bedside diagnosis of atelectasis remains challenging. Anesthesia-induced atelectasis is commonly small and thus mostly invisible on standard chest radiographs. In contrast, it can easily be diagnosed by tomographic imaging techniques such as computed tomography or magnetic resonance imaging (MRI). However, these latter are clinically impractical, expensive, time-consuming, and with harmful exposition to x-ray.
Sonography is a simple, non-invasive, and radiation-free methodology that has increased daily practice usage. Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children, including obstructive and compressive atelectasis of different origins. Just as in adults, LUS could identify children needing a recruitment maneuver to re-expand their lungs and help optimize ventilator treatment during anesthesia. LUS could also identify critically ill children with a high risk for developing pulmonary complications due to residual atelectasis after surgery.
A prospective, randomized, double-blind study in the Second Affiliated Hospital and Yuying Children Hospital of Wenzhou Medical University showed that an inspiratory pressure of 12 cm H2O was sufficient to provide adequate ventilation with a lower occurrence of gastric insufflation during induction of general anesthesia in paralyzed Chinese children aged from 2 to 4 years old.
Many studies used LUS to determine the optimum positive end-expiratory pressure (PEEP), yet no previous studies used LUS to determine the best inspiratory pressure (IP) for pressure controlled ventilation. So, this study aimed to determine the appropriate level of inspiratory pressure sufficient to provide adequate pulmonary ventilation with the resolution of anesthesia-induced lung atelectasis using real-time ultrasonography in paralyzed children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a comparative prospective randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Group A = C-PCV received conventional pressure-controlled ventilation | Experimental | Procedure: Increasing the inspiratory pressure if atelectasis detected by USInspiratory pressure will be adjusted to achieve an expired tidal volume of 7 ml/Kg; the respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H2O, and FiO2 at 0.5. No further adjustment in IP will be made throughout the surgery. LUS will be performed at the same fixed four-time interval as Group-B. Anesthesiologist will not do any interventions to the atelectatic areas in this group. |
| Group B = US-PCV: received ultrasound-guided pressure-controlled ventilation | Active comparator | Procedure: Increasing the inspiratory pressure if atelectasis detected by USInitial IP will be ten cmH2O, PEEP 4 cmH2O with a 0.5 inspired oxygen fraction, and RR 12 breaths/min. Then under ultrasound guidance, a stepwise increase in inspiratory pressure from 10 cmH2O by 2 cmH2O increments every 5 min until the atelectasis disappeared on ultrasound (progression from lung collapse to B lines to normal lung image). The IP will be fixed at this level, and RR will be adjusted to maintain an EtCO2 at 32-35 mmHg. The maximum airway pressure will be limited to 35 cmH2O. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children's age starting from 5 to 12 years.
- Genders eligible for the study: both sexes.
- ASA I-II.
- They were scheduled for elective Abdomino-pelvic surgery lasting > 1.5 hours duration.
Key exclusion criteria (6 listed)
- Parent refusal
- Emergency cases
- Laparoscopic surgeries
- Acute respiratory disease, pulmonary or lung diseases
- Lung consolidation score ≥ 2 before intubation
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 |
|---|---|---|
| Increasing the inspiratory pressure if atelectasis detected by USThe study used US to detect presence of lung atelectasis under mechanical ventilation in pediatrics. Inspiratory pressure increased gradually with continuous monitoring by lung US to minimize the atelectasis as possible. | Procedure or surgery | Group A = C-PCV received conventional pressure-controlled ventilation, Group B = US-PCV: received ultrasound-guided pressure-controlled ventilation |
Primary outcome
Incidence of significant anesthesia-induced lung collapse diagnosed by LUS examined at T2.
Time frame: 1 minute after skin closure and before extubation (T2)
Significant lung atelectasis will be defined as any region that had a lung consolidation score of ≥2.
2 secondary outcomes
Time in minutes to resumption of normal lung aeration in the consolidated area started from diagnosis of collapse (T1) until lung consolidation score < 2 in group US-PCV
Time frame: "from diagnosis of collapse until lung consolidation score < 2 in group US-PCV (assessed up to 5 minutes)"
Incidence of lung collapse in the two groups as detected by lung US at the 3rd formal lung ultrasound examination (T2).
Time frame: 1 minute after skin closure and before extubation
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 3 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Pediatric Lung Atelectasis
Not yet recruiting
Evaluation of the Effect of Perioperative Recruitment Maneuver Practice on Lung Ultrasound Score and Mechanical Power in Pediatric Patients
Postoperative Pulmonary Complications, Postoperative Pulmonary Atelectasis
Active, not recruiting
Brochoscopic Intervention Versus Conventional Management in Acute Lung Collapse in the Pediatric Intensive Care Unit
Lung Collapse
Not yet recruiting
VCV vs PRVC in Pediatric Anesthesia; an EIT- and LS-based Study
Atelectasis
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.
Sherif Soaida, MD study director
Cairo University
Hany Mohammed, MD study director
Cairo University
Mohamed Mohamed, MD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increasing the inspiratory pressure if atelectasis detected by US in people with Pediatric Lung Atelectasis, run by Cairo 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 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 3 Jan 2024. 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?
Incidence of significant anesthesia-induced lung collapse diagnosed by LUS examined at T2. (time frame: 1 minute after skin closure and before extubation (T2)). 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 3 Jan 2024.