PediatricNCT03352375
Positive Pressure Ventilation Through a Laryngeal Mask Airway in Pediatrics
A study testing Orotracheally intubation and Laryngeal Mask Airway in people with Pediatric and Anesthesia, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
The investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 1 year to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric, Anesthesia
- What is being tested?
- Orotracheally intubation and Laryngeal Mask Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Oct 2016
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society of Anesthesiologists physical status I, being scheduled to undergo laparoscopic inguinal hernia.
Who cannot join
- Patients, who did not want to participate, patients with severe airway deformities, patients having increased gastroesophageal regurgitation risk, reactive airway hiatal hernia, peripheric vascular disease, mental retardation, neuropsychiatric illness or an lung infection during the last 6 weeks.
About this study
Official title: Can Positive Pressure Ventilation be Provided Through a Laryngeal Mask Airway in Pediatrics During Laparoscopic Inguinal Hernia Repair?
The investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair.
Read the detailed description
Considering blood gas analysis, end tidal carbon dioxide measurements and airway changes, the investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair in this study.
- Conditions
- Pediatric, Anesthesia
- Being tested
- Orotracheally intubation, Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orotracheally intubationDevice
Interventions used for airway safety and ventilation during surgical procedures
Laryngeal Mask AirwayDevice
Interventions used for airway safety and ventilation during surgical procedures
| Study group | Role | What they receive |
|---|---|---|
| Orotracheally Intubation | Active comparator | Intervention:orotracheally intubation Receives: Device: Orotracheally intubation |
| Laryngeal Mask Airway | Active comparator | Intervention: Laryngeal Mask Airway Receives: Device: Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
end tidal carbon dioxide
A parameter measured during positive pressure ventilation
Measured: up to 200 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startMay 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PediatricStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All pediatric patients, who were scheduled to undergo laparoscopic surgery
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Tulay ISIL, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Canan Tulay Isil, MD, Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352375
- Sponsor's protocol ID
- SEEAH 462/17.03.2015
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data can only be shared without patients names
Publications
Sinha A, Sharma B, Sood J. ProSeal as an alternative to endotracheal intubation in pediatric laparoscopy. Paediatr Anaesth. 2007 Apr;17(4):327-32. doi: 10.1111/j.1460-9592.2006.02127.x.
PubMed 17359400
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Positive Pressure Ventilation be Provided Through a Laryngeal Mask Airway in Pediatrics During Laparoscopic Inguinal Hernia Repair?
- ClinicalTrials.gov ID
- NCT03352375
- Acronym / sponsor ID
- SEEAH 462/17.03.2015
- Conditions
- Pediatric, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Nov 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.
The investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair.
Detailed description
Considering blood gas analysis, end tidal carbon dioxide measurements and airway changes, the investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All pediatric patients, who were scheduled to undergo laparoscopic surgery
| Arm | Type | Receives |
|---|---|---|
| Orotracheally Intubation | Active comparator | Device: Orotracheally intubationIntervention:orotracheally intubation |
| Laryngeal Mask Airway | Active comparator | Device: Laryngeal Mask AirwayIntervention: Laryngeal Mask Airway |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status I, being scheduled to undergo laparoscopic inguinal hernia.
Key exclusion criteria (1 listed)
- Patients, who did not want to participate, patients with severe airway deformities, patients having increased gastroesophageal regurgitation risk, reactive airway hiatal hernia, peripheric vascular disease, mental retardation, neuropsychiatric illness or an lung infection during the last 6 weeks.
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 |
|---|---|---|
| Orotracheally intubationInterventions used for airway safety and ventilation during surgical procedures | Device | Orotracheally Intubation |
| Laryngeal Mask AirwayInterventions used for airway safety and ventilation during surgical procedures | Device | Laryngeal Mask Airway |
Primary outcome
end tidal carbon dioxide
Time frame: up to 200 minutes
A parameter measured during positive pressure ventilation
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 24 Nov 2017.
- Background: PubMed 17359400Sinha A, Sharma B, Sood J. ProSeal as an alternative to endotracheal intubation in pediatric laparoscopy. Paediatr Anaesth. 2007 Apr;17(4):327-32. doi: 10.1111/j.1460-9592.2006.02127.x.
- Individual participant dataSharing planned: No. Study data can only be shared without patients names
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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.
Canan Tulay Isil, MD principal investigator
Sisli Hamidiye Etfal Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Orotracheally intubation and Laryngeal Mask Airway in people with Pediatric and Anesthesia, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 1 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
end tidal carbon dioxide (time frame: up to 200 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352375, which also lists 1 linked publication.
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 24 Nov 2017.