The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic SurgeryNCT02462915
A Study Comparing the Supraglottic Airway Devices and Endotracheal Tube During Controlled Ventilation for Laparoscopic Surgery
A study testing i-gel, endotracheal tube and lidocaine, propofol, fentanyl and cisatracurium in people with The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery. The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic Surgery
- What is being tested?
- i-gel, endotracheal tube and lidocaine, propofol, fentanyl and cisatracurium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2015to Dec 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.
Who cannot join
- presence of any significant lung, heart, brain disease
- pathology of the neck or upper respiratory tract
- Potential difficult intubation
- an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,
- Obese (BMI>30),
- pregnant woman, who were confirmed by patient history and medical chart
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, National Taiwan University Hospital
Taipei
Shou-Zen Fan, MD,PhD, 886-2-23123456 ext. 62157, shouzen@gmail.com
About this study
In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.
The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.
In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.
Read the detailed description
In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.
Our patient receive i-gel or endotracheal tube by draw. These patients were Included by the criteria:1.ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.
The excluding criteria was: 1.presence of any significant lung, heart, brain disease 2. pathology of the neck or upper respiratory tract 3.Potential difficult intubation 4.an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,Obese (BMI>30), and pregnant woman, who were confirmed by patient history and medical chart.
Preoxygenation was maintained for three minutes to avoid bag and mask ventilation. Anesthesia was induced with the routine medication, such as lidocaine、 propofol, fentanyl and cisatracurium. The i-gel or endotracheal tubes were inserted. The lungs were ventilated at the tidal volume (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.
In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.
- Being tested
- i-gel, endotracheal tube, lidocaine, propofol, fentanyl and cisatracurium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gelDevice
a supraglottic airway devices without cuff and the material was Styrene Ethylene Butadiene Styrene.
gastric channel to the The gastric suction channel can facilitate venting and reduce the aspiration.
endotracheal tubeDevice
traditional and regularly use in many surgeries for maintaining the airway.
lidocaine, propofol, fentanyl and cisatracuriumDrug
| Study group | Role | What they receive |
|---|---|---|
| i-gel, an brand of supraglottic airway device | Experimental | a supraglottic airway devices with a gastric suction channel Receives: Device: i-gel; Drug: lidocaine, propofol, fentanyl and cisatracurium |
| endotracheal tube | Experimental | traditional use for protect airway during the surgery Receives: Device: endotracheal tube; Drug: lidocaine, propofol, fentanyl and cisatracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
leak fraction
(inspiratory volume-expiratory volume)/inspiratory volume
Measured: intraoperative
Secondary outcomes (1)
leak volume
inspiratory volume-expiratory volume
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462915
- Sponsor's protocol ID
- 201502043RINC
- Status last verified
- Nov 2015
- First submitted
- 1 Jun 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Uppal V, Fletcher G, Kinsella J. Comparison of the i-gel with the cuffed tracheal tube during pressure-controlled ventilation. Br J Anaesth. 2009 Feb;102(2):264-8. doi: 10.1093/bja/aen366.
PubMed 19151051Lai CJ, Liu CM, Wu CY, Tsai FF, Tseng PH, Fan SZ. I-Gel is a suitable alternative to endotracheal tubes in the laparoscopic pneumoperitoneum and trendelenburg position. BMC Anesthesiol. 2017 Jan 6;17(1):3. doi: 10.1186/s12871-016-0291-1.
PubMed 28125979
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing the Supraglottic Airway Devices and Endotracheal Tube During Controlled Ventilation for Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02462915
- Acronym / sponsor ID
- 201502043RINC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Jun 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.
In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.
The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.
In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.
Detailed description
In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.
Our patient receive i-gel or endotracheal tube by draw. These patients were Included by the criteria:1.ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.
The excluding criteria was: 1.presence of any significant lung, heart, brain disease 2. pathology of the neck or upper respiratory tract 3.Potential difficult intubation 4.an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,Obese (BMI>30), and pregnant woman, who were confirmed by patient history and medical chart.
Preoxygenation was maintained for three minutes to avoid bag and mask ventilation. Anesthesia was induced with the routine medication, such as lidocaine、 propofol, fentanyl and cisatracurium. The i-gel or endotracheal tubes were inserted. The lungs were ventilated at the tidal volume (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.
In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-gel, an brand of supraglottic airway device | Experimental | Device: i-gel, Drug: lidocaine, propofol, fentanyl and cisatracuriuma supraglottic airway devices with a gastric suction channel |
| endotracheal tube | Experimental | Device: endotracheal tube, Drug: lidocaine, propofol, fentanyl and cisatracuriumtraditional use for protect airway during the surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.
Key exclusion criteria (6 listed)
- presence of any significant lung, heart, brain disease
- pathology of the neck or upper respiratory tract
- Potential difficult intubation
- an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,
- Obese (BMI>30),
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 |
|---|---|---|
| i-gela supraglottic airway devices without cuff and the material was Styrene Ethylene Butadiene Styrene. gastric channel to the The gastric suction channel can facilitate venting and reduce the aspiration. | Device | i-gel, an brand of supraglottic airway device |
| endotracheal tubetraditional and regularly use in many surgeries for maintaining the airway. | Device | endotracheal tube |
| lidocaine, propofol, fentanyl and cisatracurium | Drug | endotracheal tube, i-gel, an brand of supraglottic airway device |
Primary outcome
leak fraction
Time frame: intraoperative
(inspiratory volume-expiratory volume)/inspiratory volume
1 secondary outcome
leak volume
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Background: PubMed 19151051Uppal V, Fletcher G, Kinsella J. Comparison of the i-gel with the cuffed tracheal tube during pressure-controlled ventilation. Br J Anaesth. 2009 Feb;102(2):264-8. doi: 10.1093/bja/aen366.
- Derived from this study: PubMed 28125979Lai CJ, Liu CM, Wu CY, Tsai FF, Tseng PH, Fan SZ. I-Gel is a suitable alternative to endotracheal tubes in the laparoscopic pneumoperitoneum and trendelenburg position. BMC Anesthesiol. 2017 Jan 6;17(1):3. doi: 10.1186/s12871-016-0291-1.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-gel, endotracheal tube and lidocaine, propofol, fentanyl and cisatracurium in people with The Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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 16 Nov 2015. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shou-Zen Fan, PhD,doctor (886-23123456 ext. 65523, shouzen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leak fraction (time frame: intraoperative). 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 NCT02462915, which also lists 2 linked publications.
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 16 Nov 2015.