Airway MorbidityNCT02877940
Comparison of ProSeal Laryngeal Mask Airway, LTS-D and I-gel in Mechanically Ventilated Patients
A study testing ProSeal Laryngeal mask airway, Laryngeal Tube Suction- Disposable and i-gel in people with Airway Morbidity, run by Government Medical College, Haldwani.
Trial summary
The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation undergoing elective surgical procedure. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- ProSeal Laryngeal mask airway, Laryngeal Tube Suction- Disposable and i-gel
- 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
- Dec 2014to Aug 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) class I/II.
- Age 20-60years of either sex.
- Weight between 40-60 kg of either sex.
- Elective Surgical procedures of duration of 1-1½ hour with no need for endotracheal intubation.
Who cannot join
- Patient with risk factors for difficult airway. (Mouth opening of <2cm, Mallampati class 4, limited neck extension, history of previous difficult intubation)
- Any known pulmonary and cardiovascular diseases.
- Risk of aspiration. (Full stomach, hiatus hernia, gastro-oesophageal reflex disease, emergency surgery)
About this study
Official title: A Randomized Controlled Trial Comparing Proseal Laryngeal Mask Airway, I-gel Airway and Laryngeal Tube Suction-D in Mechanically Ventilated Patients
The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation undergoing elective surgical procedure.
Read the detailed description
The study aims to draw a comparison between ProSeal LMA, i-gel and LTS-D supraglottic airway devices in terms of the efficacy and safety in anaesthetised patient on Mechanical ventilation undergoing elective surgical procedure.
Methodology: A prospective randomized control study conducted on 150 patients undergoing elective surgical procedure under general anaesthesia at Dr Sushila Tiwari Hospital and Government medical college, Haldwani.
Following detailed pre-anaesthetic check-up, informed written consent was taken from patient fulfilling the required criteria. Patients were randomly allocated into 3 groups namely Group I (i-gel, n=50), Group P (p-LMA, n=50) and Group L (LTS-D, n=50) by online generated randomization.
Standard general anaesthesia protocol was followed and once adequate depth was achieved i-gel or p-LMA or LTS-D appropriate for weight or / and height was selected and inserted. An effective airway was confirmed and device was fixed from maxilla to maxilla.
The three groups were compared with respect to number of Insertion attempts, ease of insertion of device, time taken for placement of device, airway sealing pressure, ease and number of attempts of gastric tube placement and complications noted if any.
- Conditions
- Airway Morbidity
- Being tested
- ProSeal Laryngeal mask airway, Laryngeal Tube Suction- Disposable, i-gel
- Keywords
- ProSeal LMA, LTS-D, i-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSeal Laryngeal mask airwayDevice
ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.
Laryngeal Tube Suction- DisposableDevice
LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.
i-gelDevice
i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.
| Study group | Role | What they receive |
|---|---|---|
| ProSeal Laryngeal mask airway | Active comparator | ProSeal will be inserted in mechanically ventilated patients undergoing elective surgeries. Receives: Device: ProSeal Laryngeal mask airway |
| Laryngeal Tube Suction- Disposable | Active comparator | LTS-D will be inserted in mechanically ventilated patients undergoing elective surgeries. Receives: Device: Laryngeal Tube Suction- Disposable |
| Group I | Active comparator | i-gel will be inserted in mechanically ventilated patients undergoing elective surgeries.. Receives: Device: i-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Insertion attempts
Measured: 10 mins
Secondary outcomes (5)
Grading of insertion of device by Easy or Difficult
Easy insertion is defined as no resistance to insert in first attempt. Any repeat attempt or resistance to insertion is defined as Difficult.
Measured: 10 min
Time taken for placement of device
Measured: 10 min
Airway sealing pressure
Measured: 10 min
Number of attempts of gastric tube placement
Measured: 20 min
Complication
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startDec 2014
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Haldwani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Subhro Mitra, Government Medical College, Haldwani
- Investigators
- Geeta Bhandari, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877940
- Sponsor's protocol ID
- 203/GMC/IEC/04/2014
- Status last verified
- Aug 2016
- First submitted
- 17 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Proseal Laryngeal Mask Airway, I-gel Airway and Laryngeal Tube Suction-D in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT02877940
- Acronym / sponsor ID
- 203/GMC/IEC/04/2014
- Conditions
- Airway Morbidity
- Keywords
- ProSeal LMA, LTS-D, i-gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Government Medical College, HaldwaniUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Aug 2016 (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.
The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation undergoing elective surgical procedure.
Detailed description
The study aims to draw a comparison between ProSeal LMA, i-gel and LTS-D supraglottic airway devices in terms of the efficacy and safety in anaesthetised patient on Mechanical ventilation undergoing elective surgical procedure.
Methodology: A prospective randomized control study conducted on 150 patients undergoing elective surgical procedure under general anaesthesia at Dr Sushila Tiwari Hospital and Government medical college, Haldwani.
Following detailed pre-anaesthetic check-up, informed written consent was taken from patient fulfilling the required criteria. Patients were randomly allocated into 3 groups namely Group I (i-gel, n=50), Group P (p-LMA, n=50) and Group L (LTS-D, n=50) by online generated randomization.
Standard general anaesthesia protocol was followed and once adequate depth was achieved i-gel or p-LMA or LTS-D appropriate for weight or / and height was selected and inserted. An effective airway was confirmed and device was fixed from maxilla to maxilla.
The three groups were compared with respect to number of Insertion attempts, ease of insertion of device, time taken for placement of device, airway sealing pressure, ease and number of attempts of gastric tube placement and complications noted if any.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ProSeal Laryngeal mask airway | Active comparator | Device: ProSeal Laryngeal mask airwayProSeal will be inserted in mechanically ventilated patients undergoing elective surgeries. |
| Laryngeal Tube Suction- Disposable | Active comparator | Device: Laryngeal Tube Suction- DisposableLTS-D will be inserted in mechanically ventilated patients undergoing elective surgeries. |
| Group I | Active comparator | Device: i-geli-gel will be inserted in mechanically ventilated patients undergoing elective surgeries.. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anaesthesiologists (ASA) class I/II.
- Age 20-60years of either sex.
- Weight between 40-60 kg of either sex.
- Elective Surgical procedures of duration of 1-1½ hour with no need for endotracheal intubation.
Key exclusion criteria (3 listed)
- Patient with risk factors for difficult airway. (Mouth opening of <2cm, Mallampati class 4, limited neck extension, history of previous difficult intubation)
- Any known pulmonary and cardiovascular diseases.
- Risk of aspiration. (Full stomach, hiatus hernia, gastro-oesophageal reflex disease, emergency surgery)
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 |
|---|---|---|
| ProSeal Laryngeal mask airwayProSeal was inserted in mechanically ventilated patients undergoing elective surgeries. | Device | ProSeal Laryngeal mask airway |
| Laryngeal Tube Suction- DisposableLTS-D was inserted in mechanically ventilated patients undergoing elective surgeries. | Device | Laryngeal Tube Suction- Disposable |
| i-geli-gel was inserted in mechanically ventilated patients undergoing elective surgeries. | Device | Group I |
Primary outcome
Number of Insertion attempts
Time frame: 10 mins
5 secondary outcomes
Grading of insertion of device by Easy or Difficult
Time frame: 10 min
Time taken for placement of device
Time frame: 10 min
Airway sealing pressure
Time frame: 10 min
Number of attempts of gastric tube placement
Time frame: 20 min
Complication
Time frame: 120 min
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 Aug 2016.
- 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.
Geeta Bhandari, MD principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
A study testing ProSeal Laryngeal mask airway, Laryngeal Tube Suction- Disposable and i-gel in people with Airway Morbidity, run by Government Medical College, Haldwani.
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 4 inclusion and 3 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 Aug 2016. 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?
Number of Insertion attempts (time frame: 10 mins). 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 24 Aug 2016.