Lung CollapseNCT03142997
Spontaneous Ventilation Versus Controlled Ventilation on Lung Atelectasis in Children.
An observational study of Lung Collapse, run by Cairo University at 1 site in Egypt.
Trial summary
This is an observational study to compare the effect of spontaneous ventilation versus controlled ventilation on lung atelectasis using lung score measured by lung ultrasound. the study will be conducted in children hospital of Cairo University Hospitals and study population will be : children aged from one to eight… Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Lung Collapse
- What is being tested?
- Lung ultrasound
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2017to 15 Sep 2017
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: children undergoing anesthesia for non-major surgical procedures in Cairo Univesity children hospital.
Who may be able to join
- ASA physical status I-II
- Children undergoing minor surgeries in supine position.
Who cannot join
- Parents' refusal.
- Patients with congenital heart disease.
- Patients with chronic pulmonary disease ( asthma, bronchiectasis, emphysematous disease, etc.,)
- Patients with respiratory tract infection.
- Patients with chest wall deformities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Spontaneous Ventilation Versus Controlled Ventilation on Lung Atelectasis Assessed by Lung Ultrasound in Children.
This is an observational study to compare the effect of spontaneous ventilation versus controlled ventilation on lung atelectasis using lung score measured by lung ultrasound. the study will be conducted in children hospital of Cairo University Hospitals and study population will be : children aged from one to eight years of age. primary outcome will be the lung score measured by lung ultrasound.
Read the detailed description
Randomization will be done by computer generated numbers and concealed by serially numbered,opague and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group. All children will be premedicated with oral midazolam 0.5mg/kg half hour before procedure and atropine at a dose of 0.01-0.02 mg/kg (IM). Continuous electrocardiogram (ECG), pulse oximetry, non-invasive arterial blood pressure, and temperature monitoring will be applied and all patients will be induced with inhalational anesthetic using Sevoflurane+ oxygen (O2) with mac 6%. After deepening of the anesthesia, intravenous (I.V.) line will be inserted and fentanyl 1μg/kg. Patient will be divided into two groups; group S (spontaneous) will be intubated and maintained spontaneously with Ayres T piece circuit on isoflurane + oxygen with mac 2% and with fresh gas flow 2 times minute ventilation of patient to avoid co2 rebreathing . Group C (controlled) will receive muscle given in the form of atracurium 0.5mg/kg and patients will be intubated by appropriate size of endotracheal tube. Patients in controlled group will be ventilated at 6 ml/ kg tidal volume, Inspiratory to expiratory (I: E) ratio 1:2, Fio2 1 and PEEP 5 cmH2o.
10 minutes after induction lung ultrasound will be done to assess lung score and arterial blood gases will be withdrawn. At the end of surgery lung ultrasound (LUS) will be done again and another blood gases will be taken.
LUS will be performed with the portable echograph MicroMax (SonoSite, M-turbo) using a linear probe of 3 to 6 MHz. Each hemithorax will be divided into six sections using three longitudinal lines (parasternal, anterior, and posterior axillary) and two axial lines, one above the diaphragm and another one 1 cm above the nipples.
As LUS provides regional information, we will repeat the following examination sequence in each hemithorax and in all patients: (1) anterior, (2) lateral, and (3) posterior regions starting from the diaphragm (caudal lung) and moving toward the apex (cranial lung). Each hemithorax will be assessed using the two-dimensional classical view placing the probe parallel to the ribs .The LUS of a normal lung shows a lung sliding (caused by the respiratory movement of the visceral pleura relative to the fixed parietal pleura) and A lines (repetitive horizontal reverberation artifacts generated by air within the lungs separated by regular intervals, the distances of which being equal that between the skin and the pleural line).
The lung ultrasound (LUS) assessment will be segmented in anterior , lateral (L) and posterior (P) regions in both lungs. The dotted black axial line separated the lungs in superior and inferior portions. Ovals depicted where the probe is placed in the classical LUS approach: mid-clavicular, lateral and posterior axillary lines.
Anesthesia-induced atelectasis would be associated with the following LUS signs:
- Localized iso- or hypoechoic areas as compared with the highly reflective or anechoic normally aerated lung tissue.21-25 This consolidation or tissue-like pattern is caused by a loss of lung aeration. It commonly arises from the pleural line and thus can be described as Juxtapleural consolidations of various sizes.
- Static air bronchograms are observed as bright echogenic branching structures within these lung consolidations.
- The juxtapleural consolidations commonly erases the typical normal A lines and a few focal B lines (vertical, laser-like lines that erase normal A lines) can be observed below them.
- The lack of local respiratory movement or lung sliding and the presence of the pulse sign (a small motion within the lungs caused by the transmission of heart beats through the atelectatic area) are sometimes observed in large atelectatic areas.
Patients' demographic data will be collected; age, gender, weight, height, type of surgery and duration of surgery.
Lung ultrasound examinations will be performed at different time-points 10 minutes after induction of general anesthesia and before extubation to detect lung atelectasis. Arterial blood samples will be collected simultaneously to measure Pao2.
Atelectasis will be assessed by ultrasound using lung aeration score applied for each region. Lung score is four points (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation) so, applying score for 12 regions bilateral will result in maximum score 36 and lowest score 0.
Assessment of postoperative pulmonary complications like; postoperative lung collapse, postoperative pneumonia.
- Conditions
- Lung Collapse
- Being tested
- Lung ultrasound
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
we will perform lung ultrasound for both groups to calculate lung score.
| Study group | Role | What they receive |
|---|---|---|
| group S | anesthetized children on spontaneous ventilation. Receives: Diagnostic Test: Lung ultrasound | |
| group C | anesthetized children on controlled ventilation. Receives: Diagnostic Test: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygen tension (Pao2)
Measured: 10 minutes following induction of general anesthesia
Secondary outcomes (2)
The lung aeration score
lung ultrasound will be per formed on 6 areas on each hemi-thorax and the total score will be calculated (from 0-3 on each area, so the total will be 36 maximum).
Measured: 10 minutes following induction of general anesthesia
Correlation between lung score and Pao2.
Measured: 10 minutes following induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start20 Apr 2017
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CollapseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Lotfy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142997
- Sponsor's protocol ID
- N-24-2017
- Status last verified
- Dec 2017
- First submitted
- 4 May 2017
- Last updated
- 5 Dec 2017
- 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 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spontaneous Ventilation Versus Controlled Ventilation on Lung Atelectasis Assessed by Lung Ultrasound in Children.
- ClinicalTrials.gov ID
- NCT03142997
- Acronym / sponsor ID
- N-24-2017
- Conditions
- Lung Collapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 8 May 2017 (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 is an observational study to compare the effect of spontaneous ventilation versus controlled ventilation on lung atelectasis using lung score measured by lung ultrasound. the study will be conducted in children hospital of Cairo University Hospitals and study population will be : children aged from one to eight years of age. primary outcome will be the lung score measured by lung ultrasound.
Detailed description
Randomization will be done by computer generated numbers and concealed by serially numbered,opague and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group. All children will be premedicated with oral midazolam 0.5mg/kg half hour before procedure and atropine at a dose of 0.01-0.02 mg/kg (IM). Continuous electrocardiogram (ECG), pulse oximetry, non-invasive arterial blood pressure, and temperature monitoring will be applied and all patients will be induced with inhalational anesthetic using Sevoflurane+ oxygen (O2) with mac 6%. After deepening of the anesthesia, intravenous (I.V.) line will be inserted and fentanyl 1μg/kg. Patient will be divided into two groups; group S (spontaneous) will be intubated and maintained spontaneously with Ayres T piece circuit on isoflurane + oxygen with mac 2% and with fresh gas flow 2 times minute ventilation of patient to avoid co2 rebreathing . Group C (controlled) will receive muscle given in the form of atracurium 0.5mg/kg and patients will be intubated by appropriate size of endotracheal tube. Patients in controlled group will be ventilated at 6 ml/ kg tidal volume, Inspiratory to expiratory (I: E) ratio 1:2, Fio2 1 and PEEP 5 cmH2o.
10 minutes after induction lung ultrasound will be done to assess lung score and arterial blood gases will be withdrawn. At the end of surgery lung ultrasound (LUS) will be done again and another blood gases will be taken.
LUS will be performed with the portable echograph MicroMax (SonoSite, M-turbo) using a linear probe of 3 to 6 MHz. Each hemithorax will be divided into six sections using three longitudinal lines (parasternal, anterior, and posterior axillary) and two axial lines, one above the diaphragm and another one 1 cm above the nipples.
As LUS provides regional information, we will repeat the following examination sequence in each hemithorax and in all patients: (1) anterior, (2) lateral, and (3) posterior regions starting from the diaphragm (caudal lung) and moving toward the apex (cranial lung). Each hemithorax will be assessed using the two-dimensional classical view placing the probe parallel to the ribs .The LUS of a normal lung shows a lung sliding (caused by the respiratory movement of the visceral pleura relative to the fixed parietal pleura) and A lines (repetitive horizontal reverberation artifacts generated by air within the lungs separated by regular intervals, the distances of which being equal that between the skin and the pleural line).
The lung ultrasound (LUS) assessment will be segmented in anterior , lateral (L) and posterior (P) regions in both lungs. The dotted black axial line separated the lungs in superior and inferior portions. Ovals depicted where the probe is placed in the classical LUS approach: mid-clavicular, lateral and posterior axillary lines.
Anesthesia-induced atelectasis would be associated with the following LUS signs:
- Localized iso- or hypoechoic areas as compared with the highly reflective or anechoic normally aerated lung tissue.21-25 This consolidation or tissue-like pattern is caused by a loss of lung aeration. It commonly arises from the pleural line and thus can be described as Juxtapleural consolidations of various sizes.
- Static air bronchograms are observed as bright echogenic branching structures within these lung consolidations.
- The juxtapleural consolidations commonly erases the typical normal A lines and a few focal B lines (vertical, laser-like lines that erase normal A lines) can be observed below them.
- The lack of local respiratory movement or lung sliding and the presence of the pulse sign (a small motion within the lungs caused by the transmission of heart beats through the atelectatic area) are sometimes observed in large atelectatic areas.
Patients' demographic data will be collected; age, gender, weight, height, type of surgery and duration of surgery.
Lung ultrasound examinations will be performed at different time-points 10 minutes after induction of general anesthesia and before extubation to detect lung atelectasis. Arterial blood samples will be collected simultaneously to measure Pao2.
Atelectasis will be assessed by ultrasound using lung aeration score applied for each region. Lung score is four points (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation) so, applying score for 12 regions bilateral will result in maximum score 36 and lowest score 0.
Assessment of postoperative pulmonary complications like; postoperative lung collapse, postoperative pneumonia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group S | – | Diagnostic Test: Lung ultrasoundanesthetized children on spontaneous ventilation. |
| group C | – | Diagnostic Test: Lung ultrasoundanesthetized children on controlled ventilation. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children undergoing anesthesia for non-major surgical procedures in Cairo Univesity children hospital.
Key inclusion criteria (2 listed)
- ASA physical status I-II
- Children undergoing minor surgeries in supine position.
Key exclusion criteria (5 listed)
- Parents' refusal.
- Patients with congenital heart disease.
- Patients with chronic pulmonary disease ( asthma, bronchiectasis, emphysematous disease, etc.,)
- Patients with respiratory tract infection.
- Patients with chest wall deformities.
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 ultrasoundwe will perform lung ultrasound for both groups to calculate lung score. | Diagnostic test | group C, group S |
Primary outcome
Arterial oxygen tension (Pao2)
Time frame: 10 minutes following induction of general anesthesia
2 secondary outcomes
The lung aeration score
Time frame: 10 minutes following induction of general anesthesia
Correlation between lung score and Pao2.
Time frame: 10 minutes following induction of general anesthesia
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 5 Dec 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Collapse, 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 2 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 5 Dec 2017. 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?
Arterial oxygen tension (Pao2) (time frame: 10 minutes following induction of general 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 5 Dec 2017.