AnesthesiaPhase 2LRvsCPAPNCT02502279
Lung Recruitment and Postoperative CPAP
A Phase 2 study testing Engström Datex-Ohmeda ICU Ventilator and Postoperative CPAP mask in people with Anesthesia, run by Assiut University at 1 site in Egypt.
Trial summary
General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation. Read more about this study
- Who is it for?
- Ages 6 months to 6 years, men only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Engström Datex-Ohmeda ICU Ventilator and Postoperative CPAP mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2015to Feb 2016
- Phase
- Phase 2
- 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 6 months to 6 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients undergoing laparoscopic surgery for abdominal cryptorchidism.
Who cannot join
- Cardio-respiratory illness.
- Unsatisfactory preoperative peripheral arterial oxygen saturation.
- Unsatisfactory preoperative hemoglobin level.
- Neurological or psychiatric disease.
- Children with a BMI >95th percentile for age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Recruitment and Postoperative CPAP in Pediatric Laparoscopic Surgery
General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation.
Read the detailed description
General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation. However, the effect of recruitment manoeuvre is short lasting and does not extend to the post operative period. Postoperative CPAP keeps the lung open and can improve oxygenation in the early postoperative period.
- Conditions
- Anesthesia
- Being tested
- Engström Datex-Ohmeda ICU Ventilator, Postoperative CPAP mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engström Datex-Ohmeda ICU VentilatorDevice
patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation.
Postoperative CPAP maskDevice
patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation and a CPAP mask will be applied immediately postoperative.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters with 0 PEEP/CPAP. |
| Lung Recruitment- PEEP group | Active comparator | Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters plus lung recruitment manoeuvre with peak inflation pressure 35 cmH2O for 15 seconds followed by PEEP until extubation delivered by the ventilator. Receives: Device: Engström Datex-Ohmeda ICU Ventilator |
| Lung Recruitment- PEEP and CPAP group | Active comparator | Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters plus
1. lung recruitment manoeuvre with peak inflation pressure 35 cmH2O for 15 seconds followed by PEEP until extubation delivered by the ventilator.
2. Postoperative CPAP mask immediately after extubation Receives: Device: Engström Datex-Ohmeda ICU Ventilator; Device: Postoperative CPAP mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
(A-a) DO2
arterial blood gas will be withdrawn 1 hour after extubation and the alveolar minus arterial oxygen difference will be calculated for assessment of oxygenation
Measured: 1 hour after extubation
Secondary outcomes (7)
PaO2
arterial blood gas samples will be withdrawn to assess Pa O2.
Measured: intra-operative and 1hour postoperative
PaCO2
arterial blood gas samples will be withdrawn to assess PaCO2.
Measured: intra-operative and 1hour postoperative
PH
arterial blood gas samples will be withdrawn to assess PH.
Measured: intra-operative and 1hour postoperative
Respiratory mechanics
intra-operative ventilator data will be recorded to measure respiratory mechanics such as dynamic and statistic compliance
Measured: Intraoperative
non invasive mean arterial pressure
non invasive mean arterial pressure will be recorded before and after recruitment manouvre, after pneumoperitonium and after pneumoperitonium deflation
Measured: intraoperative and 1hour postoperative
Heart rate
the heart rate will be recorded before and after recruitment manoeuvre, after pneumoperitonium, and after pneumoperitonium deflation and early postoperative..
Measured: intraoperative and 1hour postoperative
Peripheral arterial oxygenation SPO2%
The SPO2% will be recorded before and after recruitment manouvre, after peumoperitoneum inflation and after pneumoperitoneum deflation and early postoperative
Measured: intraoperative and 1hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 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, Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502279
- Sponsor's protocol ID
- IRB00008718/ refer.34
- Acronym
- LRvsCPAP
- Status last verified
- Mar 2017
- First submitted
- 11 Jul 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Recruitment and Postoperative CPAP in Pediatric Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02502279
- Acronym / sponsor ID
- LRvsCPAP / IRB00008718/ refer.34
- Conditions
- Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Jul 2015 (estimated)
- 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.
General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation.
Detailed description
General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation. However, the effect of recruitment manoeuvre is short lasting and does not extend to the post operative period. Postoperative CPAP keeps the lung open and can improve oxygenation in the early postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters with 0 PEEP/CPAP. |
| Lung Recruitment- PEEP group | Active comparator | Device: Engström Datex-Ohmeda ICU VentilatorEngström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters plus lung recruitment manoeuvre with peak inflation pressure 35 cmH2O for 15 seconds followed by PEEP until extubation delivered by the ventilator. |
| Lung Recruitment- PEEP and CPAP group | Active comparator | Device: Engström Datex-Ohmeda ICU Ventilator, Device: Postoperative CPAP maskEngström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters plus 1. lung recruitment manoeuvre with peak inflation pressure 35 cmH2O for 15 seconds followed by PEEP until extubation delivered by the ventilator. 2. Postoperative CPAP mask immediately after extubation |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients undergoing laparoscopic surgery for abdominal cryptorchidism.
Key exclusion criteria (5 listed)
- Cardio-respiratory illness.
- Unsatisfactory preoperative peripheral arterial oxygen saturation.
- Unsatisfactory preoperative hemoglobin level.
- Neurological or psychiatric disease.
- Children with a BMI >95th percentile for age.
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 |
|---|---|---|
| Engström Datex-Ohmeda ICU Ventilatorpatients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation. | Device | Lung Recruitment- PEEP and CPAP group, Lung Recruitment- PEEP group |
| Postoperative CPAP maskpatients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation and a CPAP mask will be applied immediately postoperative. | Device | Lung Recruitment- PEEP and CPAP group |
Primary outcome
(A-a) DO2
Time frame: 1 hour after extubation
arterial blood gas will be withdrawn 1 hour after extubation and the alveolar minus arterial oxygen difference will be calculated for assessment of oxygenation
7 secondary outcomes
PaO2
Time frame: intra-operative and 1hour postoperative
PaCO2
Time frame: intra-operative and 1hour postoperative
PH
Time frame: intra-operative and 1hour postoperative
Respiratory mechanics
Time frame: Intraoperative
non invasive mean arterial pressure
Time frame: intraoperative and 1hour postoperative
Heart rate
Time frame: intraoperative and 1hour postoperative
Peripheral arterial oxygenation SPO2%
Time frame: intraoperative and 1hour 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 28 Mar 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.
Hala S Abdel-Ghaffar, MD principal investigator
Assisstant professor in Anesthesia and intensive care department, 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 Phase 2 study testing Engström Datex-Ohmeda ICU Ventilator and Postoperative CPAP mask in people with Anesthesia, 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 1 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 28 Mar 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
(A-a) DO2 (time frame: 1 hour after extubation). 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 28 Mar 2017.