Anesthesia Induced AtelectasisNCT03069157
Evaluation of the Effect of Lung Recruitment and Positive End- Expiratory Pressure (PEEP) on Anesthesia Induced Atelectasis Using Lung Ultrasound
A study testing lung recruitment maneuver in people with Anesthesia Induced Atelectasis, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages.1-3 The reported incidence of anesthesia- induced atelectasis in children varies, ranging from 12 to 42% in sedated and nonintubated patients 5, 6 and from 68 to 100% in children with general… Read more about this study
- Who is it for?
- Ages 1 year to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Induced Atelectasis
- What is being tested?
- lung recruitment maneuver
- 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
- 8 Mar 2017to 15 Nov 2017
- 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 1 year to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA physical status I-II.
- Age (1-4) years.
- Patients undergoing major abdominal surgery in supine position (eg. Splenectomy, exploration, kasai etc.,).
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: Evaluation of the Effect of Lung Recruitment and Positive End- Expiratory Pressure (PEEP) on Anesthesia Induced Atelectasis Using Lung Ultrasound in Children Undergoing Major Abdominal Surgery.
Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages.1-3 The reported incidence of anesthesia- induced atelectasis in children varies, ranging from 12 to 42% in sedated and nonintubated patients 5, 6 and from 68 to 100% in children with general anesthesia with tracheal intubation or laryngeal mask.
The aim of this work is to evaluate the effect of lung recruitment on anesthesia induced atelectasis using intraoperative lung ultrasound.
Read more
Objectives
- To determine the effect of recruitment on anesthesia induced atelectasis using lung ultrasound.
- To Estimate the change of Pao2 with anesthesia induced lung atelectasis.
- To Estimate the change of Pao2 with lung recruitment.
- To evaluate the feasibility of use of lung ultrasound as a tool to guide optimum lung recruitment.
Read the detailed description
This a randomized control trial is designed to include 40 children aged from one to four years presented for major abdominal surgery.
Forty patients meeting the inclusion criteria will be randomly assigned into to two equal groups:
Group C (n= 20): Without recruitment maneuver (control group)
Group REC (n= 20): recruitment 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 2%. After deepening of the anesthesia, intravenous (I.V.) line will be inserted and fentanyl 2μg/kg, muscle relaxant will be given in the form of atracurium 0.5mg/kg and patients will be intubated by appropriate size of endotracheal tube.
After induction of anesthesia all patients will be ventilated using pressure controlled mode targeting tidal volume 6-8 ml/kg with inspiratory to expiratory ( I: E) ratio 1:1.5, and Fio2 1, baseline arterial blood gas will be withdrawn. Patients will be divided into two groups. Group (REC) recruitment group; in this group, lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O22,23. In next assessment time, if still there are atelectatic areas recruitment will be repeated and patient will be maintained at PEEP 10 cm H2O till the end of surgery. In group (C) non recruitment group, patient ventilation will be maintained on aforementioned tidal volume without recruitment but with PEEP 5cm H2O.
Lung ultrasound (LUS) 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).13,14 Each hemithorax will be assessed using the two-dimensional classical view placing the probe parallel to the ribs .24 (fig. 1).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.
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 immediately before induction of anesthesia, 5, 15 minutes following induction of general anesthesia, before extubation and after extubation at recovery room to detect and monitor 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.
The sum of surface area of atelectatic regions and the number of recruitment attempts to recruit atelectatic areas will be recorded.
Other data as heart rate, systolic, diastolic and mean arterial blood pressure will be recorded at same measuring points and during recruitment.
Assessment for incidence of pneumothorax and postoperative pulmonary complications like; postoperative lung collapse and postoperative pneumonia.
Assessment the duration of postoperative hospital stay.
- Conditions
- Anesthesia Induced Atelectasis
- Being tested
- lung recruitment maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung recruitment maneuverProcedure or surgery
lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O
| Study group | Role | What they receive |
|---|---|---|
| Without lung recruitment maneuver | No intervention | patient ventilation will be maintained After induction of anesthesia all patients will be ventilated using pressure controlled mode targeting tidal volume 6-8 ml/kg with inspiratory to expiratory ( I: E) ratio 1:1.5 without recruitment but with PEEP 5cm H2O. |
| recruitment group | Active comparator | lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O. Receives: Procedure: lung recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
The lung aeration score 5minutes following induction of general anesthesia
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
Measured: Lung ultrasound examinations will be performed 5minutes following induction of general anesthesia
Secondary outcomes (1)
•The sum of surface area of atelectatic regions
The sum of surface area of atelectatic regions and the number of recruitment attempts to recruit atelectatic areas will be recorded
Measured: It will be measured at different time-points immediately before induction of anesthesia, 5, 15 minutes following induction of general anesthesia,5 min before extubation and 5 min after extubation at recovery room to detect and monitor atelectasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start8 Mar 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Induced AtelectasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ahmed nabih youssef, Kasr El Aini Hospital
- Investigators
- Iman R Abdel- Aal, Professor, Study director, Anesthesia department , Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069157
- Sponsor's protocol ID
- N-33-2016
- Status last verified
- Jan 2018
- First submitted
- 10 Feb 2017
- Last updated
- 25 Jan 2018
- Results posted
- 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 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Lung Recruitment and Positive End- Expiratory Pressure (PEEP) on Anesthesia Induced Atelectasis Using Lung Ultrasound in Children Undergoing Major Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT03069157
- Acronym / sponsor ID
- N-33-2016
- Conditions
- Anesthesia Induced Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 3 Mar 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.
Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages.1-3 The reported incidence of anesthesia- induced atelectasis in children varies, ranging from 12 to 42% in sedated and nonintubated patients 5, 6 and from 68 to 100% in children with general anesthesia with tracheal intubation or laryngeal mask.
The aim of this work is to evaluate the effect of lung recruitment on anesthesia induced atelectasis using intraoperative lung ultrasound.
Objectives
- To determine the effect of recruitment on anesthesia induced atelectasis using lung ultrasound.
- To Estimate the change of Pao2 with anesthesia induced lung atelectasis.
- To Estimate the change of Pao2 with lung recruitment.
- To evaluate the feasibility of use of lung ultrasound as a tool to guide optimum lung recruitment.
Detailed description
This a randomized control trial is designed to include 40 children aged from one to four years presented for major abdominal surgery.
Forty patients meeting the inclusion criteria will be randomly assigned into to two equal groups:
Group C (n= 20): Without recruitment maneuver (control group)
Group REC (n= 20): recruitment 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 2%. After deepening of the anesthesia, intravenous (I.V.) line will be inserted and fentanyl 2μg/kg, muscle relaxant will be given in the form of atracurium 0.5mg/kg and patients will be intubated by appropriate size of endotracheal tube.
After induction of anesthesia all patients will be ventilated using pressure controlled mode targeting tidal volume 6-8 ml/kg with inspiratory to expiratory ( I: E) ratio 1:1.5, and Fio2 1, baseline arterial blood gas will be withdrawn. Patients will be divided into two groups. Group (REC) recruitment group; in this group, lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O22,23. In next assessment time, if still there are atelectatic areas recruitment will be repeated and patient will be maintained at PEEP 10 cm H2O till the end of surgery. In group (C) non recruitment group, patient ventilation will be maintained on aforementioned tidal volume without recruitment but with PEEP 5cm H2O.
Lung ultrasound (LUS) 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).13,14 Each hemithorax will be assessed using the two-dimensional classical view placing the probe parallel to the ribs .24 (fig. 1).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.
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 immediately before induction of anesthesia, 5, 15 minutes following induction of general anesthesia, before extubation and after extubation at recovery room to detect and monitor 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.
The sum of surface area of atelectatic regions and the number of recruitment attempts to recruit atelectatic areas will be recorded.
Other data as heart rate, systolic, diastolic and mean arterial blood pressure will be recorded at same measuring points and during recruitment.
Assessment for incidence of pneumothorax and postoperative pulmonary complications like; postoperative lung collapse and postoperative pneumonia.
Assessment the duration of postoperative hospital stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without lung recruitment maneuver | No intervention | –patient ventilation will be maintained After induction of anesthesia all patients will be ventilated using pressure controlled mode targeting tidal volume 6-8 ml/kg with inspiratory to expiratory ( I: E) ratio 1:1.5 without recruitment but with PEEP 5cm H2O. |
| recruitment group | Active comparator | Procedure: lung recruitment maneuverlung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O. |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status I-II.
- Age (1-4) years.
- Patients undergoing major abdominal surgery in supine position (eg. Splenectomy, exploration, kasai etc.,).
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 recruitment maneuverlung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O | Procedure or surgery | recruitment group |
Primary outcome
The lung aeration score 5minutes following induction of general anesthesia
Time frame: Lung ultrasound examinations will be performed 5minutes following induction of general anesthesia
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
1 secondary outcome
•The sum of surface area of atelectatic regions
Time frame: It will be measured at different time-points immediately before induction of anesthesia, 5, 15 minutes following induction of general anesthesia,5 min before extubation and 5 min after extubation at recovery room to detect and monitor atelectasis
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 Jan 2018.
- 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.
Iman R Abdel- Aal, Professor study director
Anesthesia department , 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 lung recruitment maneuver in people with Anesthesia Induced Atelectasis, run by Kasr El Aini Hospital 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 3 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 Jan 2018. 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?
The lung aeration score 5minutes following induction of general anesthesia (time frame: Lung ultrasound examinations will be performed 5minutes 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 25 Jan 2018.