Medical Device ComplicationNCT03140215
Comparative Study of Baska & I-gel for Ventilation of Female Patients During Minor Procedures
A study testing laryngeal mask insertion (Baska) and laryngeal mask insertion (I-gel ) in people with Medical Device Complication, run by Cairo University.
Trial summary
The study aimed to compare safety of the 3rd generation Supra-glottic airway device (SAD) "Baska" to the I-Gel , regarding seal pressure, fitting on the larynx (detected by Fiberoptic) \& complications. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Medical Device Complication
- What is being tested?
- laryngeal mask insertion (Baska) and laryngeal mask insertion (I-gel )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female ASA1,2
- Age 18-55
- BMI<35
Who cannot join
- Anticipated upper airway problem
- GIT disease
- Pregnancy
- High risk of aspiration
About this study
Official title: Comparative Study of Baska & I-Gel for Spontaneously Ventilated Females During Minor Gynecological Procedures
The study aimed to compare safety of the 3rd generation Supra-glottic airway device (SAD) "Baska" to the I-Gel , regarding seal pressure, fitting on the larynx (detected by Fiberoptic) \& complications. The study will be done for females undergoing minor gynecological procedures under general anesthesia with spontaneous ventilation.
Read the detailed description
Population of study \& disease condition : 2 equal groups (n=30), female patients enrolled for minor gynecological procedures (D\&C or hysteroscopy), All patients received general anesthesia with spontaneous ventilation using Supra-glottic airway Device (SAD). Group A (Baska) \& group B ( I-gel).
Inclusion Criteria: Age: 18-55, American Society of Anesthesia (ASA) 1 or 2, BMI<35 \& Low risk of aspiration.
Exclusion Criteria: Anticipated upper airway problem, Gastrointestinal tract (GIT, disease, pregnancy \& High risk of aspiration.
Methodology: All patients received fentanyl 1 micro gram/Kg, Propofol(2-4mg/Kg) was titrated to induce anesthesia, followed by manual ventilation with sevoflurane (2-4%) in Oxygen.All devices were inserted by one of 2 investigators.
Data collection: 1- Demographic Data: age,weight,height.2-duration of anesthesia.3- Data related to device insertion: Time of insertion,duration of anesthesia, seal pressure,peak airway pressure, Fiberoptic (FO)view of the larynx ,vomiting or regurgitation, postoperative laryngeal spasm or blood on the device after removal.
Primary outcome: To detect seal pressure and fitting against laryngeal aperture detected by FO. Secondary outcome:To determine Peak pressure, incidence of complications: vomiting or regurgitation, blood on the device after removal (indicating trauma to the airway) or postoperative laryngeal spasm..
Statistical analysis: For analysis of continuous variables independent sample t-test will be applied and for categorical variables chi-square test will be used.value of p<0.05 will be considered significant.
Sample size:
Sample size was calculated using EpiCalc program using the following data : mean seal pressure for Baska :29.98 , mean seal pressure for I-Gel: 25.62. SD: 4.9
, study power 80% confidence interval . P value<0.05. the calculated sample size was found to be 19 for each group (overall 38), so the investigators will allocate 30 patient in each group to avoid drop out.
Statistical analysis:
Source of funding This study will be attributed to Department of Anesthesiology, Faculty of medicine, Cairo University. Support will be provided solely from departmental sources. Keywords: Baska, I-Gel, Supra-glottic airway devices, seal pressure
- Conditions
- Medical Device Complication
- Being tested
- laryngeal mask insertion (Baska), laryngeal mask insertion (I-gel )
- Keywords
- Baska, seal pressure, I-Gel, Supraglottic airway device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal mask insertion (Baska)Device
Also called Baska
laryngeal mask insertion (I-gel )Device
Also called I-gel
| Study group | Role | What they receive |
|---|---|---|
| Baska Device ventilation group | Active comparator | Device: laryngeal mask insertion (Baska) Receives: Device: laryngeal mask insertion (Baska); Device: laryngeal mask insertion (I-gel ) |
| I-Gel device ventilation group | Active comparator | Device: laryngeal mask insertion ( I-gel ) Receives: Device: laryngeal mask insertion (Baska); Device: laryngeal mask insertion (I-gel ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
seal pressure
Airway Sealing Pressure in cmH2O at 5 mins postplacement.The airway sealing pressure was the pressure at which leak starts. This leak pressure was calculated as the plateau airway pressure reached with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O..
Measured: seal pressure will be assessed 3minutes after induction of general anesthesia.
Secondary outcomes (3)
Fiberoptic view of the larynx.
The fiberoptic device will be introduced through the device to visualize \& record the view
Measured: Fiberoptic view will be assessed 5 minutes after induction of anesthesia.
Peak airway pressure in CmH2O
The peak airway pressure will be monitored during the operation time
Measured: during the operation the operation
incidence of vomiting and regurgitation
patients will be monitored to detect vomiting \& regurgitation.
Measured: from the start of operation till 10 minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startJun 2016
- Primary completionDec 2016
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Device ComplicationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesrine El-Refai, Cairo University
- Investigators
- Nesrine A. El-Refai, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140215
- Sponsor's protocol ID
- UTF-8
- Status last verified
- May 2017
- First submitted
- 8 Jan 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Baska & I-Gel for Spontaneously Ventilated Females During Minor Gynecological Procedures
- ClinicalTrials.gov ID
- NCT03140215
- Acronym / sponsor ID
- UTF-8
- Conditions
- Medical Device Complication
- Keywords
- Baska, seal pressure, I-Gel, Supraglottic airway device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 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.
The study aimed to compare safety of the 3rd generation Supra-glottic airway device (SAD) "Baska" to the I-Gel , regarding seal pressure, fitting on the larynx (detected by Fiberoptic) \& complications. The study will be done for females undergoing minor gynecological procedures under general anesthesia with spontaneous ventilation.
Detailed description
Population of study \& disease condition : 2 equal groups (n=30), female patients enrolled for minor gynecological procedures (D\&C or hysteroscopy), All patients received general anesthesia with spontaneous ventilation using Supra-glottic airway Device (SAD). Group A (Baska) \& group B ( I-gel).
Inclusion Criteria: Age: 18-55, American Society of Anesthesia (ASA) 1 or 2, BMI<35 \& Low risk of aspiration.
Exclusion Criteria: Anticipated upper airway problem, Gastrointestinal tract (GIT, disease, pregnancy \& High risk of aspiration.
Methodology: All patients received fentanyl 1 micro gram/Kg, Propofol(2-4mg/Kg) was titrated to induce anesthesia, followed by manual ventilation with sevoflurane (2-4%) in Oxygen.All devices were inserted by one of 2 investigators.
Data collection: 1- Demographic Data: age,weight,height.2-duration of anesthesia.3- Data related to device insertion: Time of insertion,duration of anesthesia, seal pressure,peak airway pressure, Fiberoptic (FO)view of the larynx ,vomiting or regurgitation, postoperative laryngeal spasm or blood on the device after removal.
Primary outcome: To detect seal pressure and fitting against laryngeal aperture detected by FO. Secondary outcome:To determine Peak pressure, incidence of complications: vomiting or regurgitation, blood on the device after removal (indicating trauma to the airway) or postoperative laryngeal spasm..
Statistical analysis: For analysis of continuous variables independent sample t-test will be applied and for categorical variables chi-square test will be used.value of p<0.05 will be considered significant.
Sample size:
Sample size was calculated using EpiCalc program using the following data : mean seal pressure for Baska :29.98 , mean seal pressure for I-Gel: 25.62. SD: 4.9
, study power 80% confidence interval . P value<0.05. the calculated sample size was found to be 19 for each group (overall 38), so the investigators will allocate 30 patient in each group to avoid drop out.
Statistical analysis:
Source of funding This study will be attributed to Department of Anesthesiology, Faculty of medicine, Cairo University. Support will be provided solely from departmental sources. Keywords: Baska, I-Gel, Supra-glottic airway devices, seal pressure
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baska Device ventilation group | Active comparator | Device: laryngeal mask insertion (Baska), Device: laryngeal mask insertion (I-gel )Device: laryngeal mask insertion (Baska) |
| I-Gel device ventilation group | Active comparator | Device: laryngeal mask insertion (Baska), Device: laryngeal mask insertion (I-gel )Device: laryngeal mask insertion ( I-gel ) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female ASA1,2
- Age 18-55
- BMI<35
Key exclusion criteria (4 listed)
- Anticipated upper airway problem
- GIT disease
- Pregnancy
- High risk of aspiration
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 |
|---|---|---|
| laryngeal mask insertion (Baska)Also: Baska | Device | Baska Device ventilation group, I-Gel device ventilation group |
| laryngeal mask insertion (I-gel )Also: I-gel | Device | Baska Device ventilation group, I-Gel device ventilation group |
Primary outcome
seal pressure
Time frame: seal pressure will be assessed 3minutes after induction of general anesthesia.
Airway Sealing Pressure in cmH2O at 5 mins postplacement.The airway sealing pressure was the pressure at which leak starts. This leak pressure was calculated as the plateau airway pressure reached with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O..
3 secondary outcomes
Fiberoptic view of the larynx.
Time frame: Fiberoptic view will be assessed 5 minutes after induction of anesthesia.
Peak airway pressure in CmH2O
Time frame: during the operation the operation
incidence of vomiting and regurgitation
Time frame: from the start of operation till 10 minutes postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Nesrine A. El-Refai, M.D principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing laryngeal mask insertion (Baska) and laryngeal mask insertion (I-gel ) in people with Medical Device Complication, run by Cairo University.
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 4 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: status not confirmed, as of the sponsor's last update on 4 May 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?
Results are not available in the source record.
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?
seal pressure (time frame: seal pressure will be assessed 3minutes after 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 4 May 2017.