Intubation;DifficultNCT03929445
Bougie Assisted Endotracheal Intubation in Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask
A study testing Endotracheal tube introducers in people with Intubation;Difficult and Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Suez Canal University at 1 site in Egypt.
Trial summary
This study aims to compare using bougie as an assistant for endotracheal intubation through Air-Q and Fastrach intubating laryngeal mask devices when blind intubation fails as attempt to increase its success rate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intubation;Difficult, Endotracheal Tube Wrongly Placed During Anesthetic Procedure
- What is being tested?
- Endotracheal tube introducers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Nov 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged >18 years old.
- Gender both male and female.
- Patients are ASA I (American Society of Anesthesiologists' physical status Grade I) normal healthy patients or ASA II patients with mild systemic disease and no functional limitations
Who cannot join
- Any disorder of the cardiovascular, pulmonary, hepatic, renal, or gastrointestinal systems known from history or general examination.
- Patients with unstable cervical spine
- Any medical disease that may affect airway as Rheumatoid arthritis.
- Patient refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask By Using Bougie Assisted Endotracheal Intubation
This study aims to compare using bougie as an assistant for endotracheal intubation through Air-Q and Fastrach intubating laryngeal mask devices when blind intubation fails as attempt to increase its success rate.
Read the detailed description
The investigators hypothesis that using bougie with its smaller caliber or lesser size can facilitate intubation and improve success rate when blind intubation through both devices fails.
Study objectives
- To make a comparison between Air-Q intubating laryngeal mask and Fastrach intubating laryngeal mask by using bougie assisted endotracheal intubation through both devices in patients undergoing elective surgeries in Suez Canal Hospitals.
- To assess the first trial success rate, the total success rate, time to tracheal intubation, the number of attempts, hemodynamics and adverse events.
- Being tested
- Endotracheal tube introducers
- Keywords
- Bougie, Air Q, Fastrach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tube introducersDevice
Also called The Gum Elastic Bougie
Endotracheal tube introducers (gum elastic bougie) for emergency intubation The endotracheal tube introducer (ETI) is an effective and inexpensive adjunct to difficult airway management that is easy to use.
ETI is solid introducer 60-70 cm long with a 35 - 40 distally angulated (Coude) tip. They are easy to use, widely available, and have been used as adjuncts to difficult direct laryngoscopy for many decades.
The gum elastic bougie is usually guided by tactile clicks as the device passes the cartilage rings of the trachea. After Supraglottic devices are removed, an ETT can subsequently be railroaded over the bougie.
| Study group | Role | What they receive |
|---|---|---|
| AIR-Q group | Active comparator | the group which selected randomly to try AIR-Q device Receives: Device: Endotracheal tube introducers |
| I-LMA group | Active comparator | the group which selected randomly to try I-LMA device Receives: Device: Endotracheal tube introducers |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach
If the blind intubation is failed through Air Q or Fastrack Intubating laryngeal mask the investigator will use gum elastic bougie to facilitate introducing an endotracheal tube estimation of success rate of endotracheal intubation on the first, second and third attempts
Measured: 180 seconds after anethesia induction
The time needed for devices insertion (Air Q and Fastrach Intubating Laryngeal mask)
- Air Q and Fastrach Intubating laryngeal mask insertion time in seconds will be measured (device time).
- Endotracheal tube (ETT) insertion time will be measured ( ETT time).
- Total insertion time will be estimated (Device Time + ETT Time )
Measured: !80 seconds after anesthesia induction
Secondary outcomes (1)
Incidence of adverse events
Incidence of adverse events and complications during and after the procedure will be also recorded. Complications, including laryngospasm, bleeding, false passage, and sore throat will be recorded intraoperatively and in the first 48 postoperative hours.
Measured: Intraoperative and in the first 48 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study startJan 2017
- Primary completionJul 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada A.Kamhawy, Suez Canal University
- Investigators
- Ghada A. Kamhawy, Lecturer, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929445
- Sponsor's protocol ID
- Ghada
- Status last verified
- Mar 2019
- First submitted
- 8 Nov 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask By Using Bougie Assisted Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT03929445
- Acronym / sponsor ID
- Ghada
- Keywords
- Bougie, Air Q, Fastrach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 26 Apr 2019 (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.
This study aims to compare using bougie as an assistant for endotracheal intubation through Air-Q and Fastrach intubating laryngeal mask devices when blind intubation fails as attempt to increase its success rate.
Detailed description
The investigators hypothesis that using bougie with its smaller caliber or lesser size can facilitate intubation and improve success rate when blind intubation through both devices fails.
Study objectives
- To make a comparison between Air-Q intubating laryngeal mask and Fastrach intubating laryngeal mask by using bougie assisted endotracheal intubation through both devices in patients undergoing elective surgeries in Suez Canal Hospitals.
- To assess the first trial success rate, the total success rate, time to tracheal intubation, the number of attempts, hemodynamics and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIR-Q group | Active comparator | Device: Endotracheal tube introducersthe group which selected randomly to try AIR-Q device |
| I-LMA group | Active comparator | Device: Endotracheal tube introducersthe group which selected randomly to try I-LMA device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged >18 years old.
- Gender both male and female.
- Patients are ASA I (American Society of Anesthesiologists' physical status Grade I) normal healthy patients or ASA II patients with mild systemic disease and no functional limitations
Key exclusion criteria (4 listed)
- Any disorder of the cardiovascular, pulmonary, hepatic, renal, or gastrointestinal systems known from history or general examination.
- Patients with unstable cervical spine
- Any medical disease that may affect airway as Rheumatoid arthritis.
- Patient refusal to participate in the study.
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 |
|---|---|---|
| Endotracheal tube introducersAlso: The Gum Elastic BougieEndotracheal tube introducers (gum elastic bougie) for emergency intubation The endotracheal tube introducer (ETI) is an effective and inexpensive adjunct to difficult airway management that is easy to use. ETI is solid introducer 60-70 cm long with a 35 - 40 distally angulated (Coude) tip. They are easy to use, widely available, and have been used as adjuncts to difficult direct laryngoscopy for many decades. The gum elastic bougie is usually guided by tactile clicks as the device passes the cartilage rings of the trachea. After Supraglottic devices are removed, an ETT can subsequently be railroaded over the bougie. | Device | AIR-Q group, I-LMA group |
Primary outcome
success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach
Time frame: 180 seconds after anethesia induction
If the blind intubation is failed through Air Q or Fastrack Intubating laryngeal mask the investigator will use gum elastic bougie to facilitate introducing an endotracheal tube estimation of success rate of endotracheal intubation on the first, second and third attempts
The time needed for devices insertion (Air Q and Fastrach Intubating Laryngeal mask)
Time frame: !80 seconds after anesthesia induction
1. Air Q and Fastrach Intubating laryngeal mask insertion time in seconds will be measured (device time). 2. Endotracheal tube (ETT) insertion time will be measured ( ETT time). 3. Total insertion time will be estimated (Device Time + ETT Time )
1 secondary outcome
Incidence of adverse events
Time frame: Intraoperative and in the first 48 postoperative hours
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 30 Apr 2019.
- 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.
Ghada A. Kamhawy, Lecturer principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal tube introducers in people with Intubation;Difficult and Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Suez Canal 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 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: finished, as of the sponsor's last update on 30 Apr 2019. 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.
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?
success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach (time frame: 180 seconds after anethesia induction). The study lists 2 primary outcomes in all. 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 30 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.