Difficult IntubationNCT03310866
Macintosh Laryngoscope Assisted Fiberoptic Intubation
A study testing fiberoptic, airway and fiberoptic, Machintosh in people with Difficult Intubation, run by Mansoura University at 1 site in Egypt.
Trial summary
During fiberoptic endotracheal intubation, the perfect airway exposure produced by the classic curved Macintosh laryngoscope in place of head tilt -chin lift-jaw thrust maneuver may increase the accuracy and produce rapid direct vocal cord access in a short time under Inhalation anesthesia to maintain the respiratory… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- fiberoptic, airway and fiberoptic, Machintosh
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2017to 30 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with Modified Mallampati (NT-MMT) airway score III,VI
- American Society of Anaesthesiologists (ASA) physical class I-III
- Scheduled for elective cancer surgery under general anesthesia
Who cannot join
- Modified Mallampati I,II Airway scored patients.
- History of upper airway surgery.
- Patients with serious deformities of the mandible, maxilla, tongue, pharynx or larynx.
- Patients with a history of significant cardiac and pulmonary diseases,
- Obesity with BMI >40,
- Epilepsy, pregnancy, mental disease, neurological psychological disorders.
- Communication barrier.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oncolgy Center, Mansoura University,
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Macintosh Laryngoscope Assisted Flexible Fiber Optic Endotracheal Intubation Versus Classic Fiber Optic Laryngoscope Alone Endotracheal Intubation for Modified Mallampati III&IV Patients : A Prospective Randomized Controlled Study
During fiberoptic endotracheal intubation, the perfect airway exposure produced by the classic curved Macintosh laryngoscope in place of head tilt -chin lift-jaw thrust maneuver may increase the accuracy and produce rapid direct vocal cord access in a short time under Inhalation anesthesia to maintain the respiratory drive for grade III\&VI Modified Mallampati .
Read the detailed description
Managing difficult airway is critical for anesthesia-related morbidity and mortality. Fiberoptic laryngoscope is a reliable tool for endotracheal intubation in difficult airway cases (Modified Mallampatti III\&IV), but always there is difficulty to visualize the glottis due to airway tendency to collapse, classically a specific fiberoptic airway with a side way is used and it may added head tilt chin lift jaw thrust. A new technique utilizing sevoflurane anesthesia to maintain the respiratory drive without exposing the patient to the stress of the awake airway instrumentation. Simultaneous utilization of both Macintosh curved laryngoscope and Fiberoptic bronchoscope during Endotracheal intubation (ETT) will be examined for the efficacy during difficult airway management.
All patients should be examined preoperatively for the scoring Modified Mallampati or non tongue protrusion mallampati (NT-MMT) airway score. The pharyngeal structures were then evaluated and the best view (lowest class) was recorded. The classification follows m-MMT and is as follows: class 1, full visibility of tonsils, uvula, and soft palate; class 2, visibility of hard and soft palate, upper portion of tonsils and uvula; class 3, visibility of the soft and hard palate and base of the uvula; and class 4, visibility of only the hard palate, class III or IV patients were included in the study. Inhalational anesthesia use maintains the respiratory drive of the patient allowing less stressful technique.
- Conditions
- Difficult Intubation
- Being tested
- fiberoptic, airway, fiberoptic, Machintosh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic, airwayDevice
classic fiberoptic bronchoscope, fenstrated airway
fiberoptic, MachintoshDevice
oral fiberoptic brochoscopic, Machintosh laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| fiberoptic, airway | Active comparator | Classical fiberoptic intubation assisted by side fenestrated airway and head tilt- chin lift- jaw thrust by 2 anesthetist Receives: Device: fiberoptic, airway |
| fiberoptic, Machintosh | Experimental | oral Fiberoptic bronchoscopic intubation assisted by Macintosh Laryngoscope, by 2 anesthetist Receives: Device: fiberoptic, Machintosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
time from introduction of the tip of the fiber optic laryngoscope till insertion of the tube in the laryngeal inlet down in the trachea in seconds.
Measured: during intubation
Secondary outcomes (9)
lower jaw relaxation
(Relaxed= 0, not fully=1, poor= 2)
Measured: during intubation
Vocal cord position
(Abducted= 0, Intermediate opening= 1, Closed= 2)
Measured: during intubation
Neck movements
for endotracheal tube or cuff inflation (no=0, slight= 1, vigorous= 2),
Measured: during intubation and cuff inflation
Cough
(absent= 0, present=1)
Measured: during intubation and cuff inflation
1st trial success rate
in percent
Measured: during intubation
the number of trails
(1st trial=1, 2nd trial= 2, 3rd trial= 3)
Measured: during intubation
mean arterial Blood pressure (MBP)
basal, every minute during intubation, 1, 3, 5 minutes after intubation
Measured: during intubation till 5 minutes after intubation
mean heart rate (HR)
basal, every minute during intubation, 1, 3, 5 minutes after intubation
Measured: during intubation till 5 minutes after intubation
desaturation (SpO2)
oxygen saturation <90% .(Yes=1, No= 0)
Measured: during intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start15 Dec 2017
- Primary completion15 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310866
- Sponsor's protocol ID
- R/17.08.102
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2017
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macintosh Laryngoscope Assisted Flexible Fiber Optic Endotracheal Intubation Versus Classic Fiber Optic Laryngoscope Alone Endotracheal Intubation for Modified Mallampati III&IV Patients : A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03310866
- Acronym / sponsor ID
- R/17.08.102
- Conditions
- Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 16 Oct 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.
During fiberoptic endotracheal intubation, the perfect airway exposure produced by the classic curved Macintosh laryngoscope in place of head tilt -chin lift-jaw thrust maneuver may increase the accuracy and produce rapid direct vocal cord access in a short time under Inhalation anesthesia to maintain the respiratory drive for grade III\&VI Modified Mallampati .
Detailed description
Managing difficult airway is critical for anesthesia-related morbidity and mortality. Fiberoptic laryngoscope is a reliable tool for endotracheal intubation in difficult airway cases (Modified Mallampatti III\&IV), but always there is difficulty to visualize the glottis due to airway tendency to collapse, classically a specific fiberoptic airway with a side way is used and it may added head tilt chin lift jaw thrust. A new technique utilizing sevoflurane anesthesia to maintain the respiratory drive without exposing the patient to the stress of the awake airway instrumentation. Simultaneous utilization of both Macintosh curved laryngoscope and Fiberoptic bronchoscope during Endotracheal intubation (ETT) will be examined for the efficacy during difficult airway management.
All patients should be examined preoperatively for the scoring Modified Mallampati or non tongue protrusion mallampati (NT-MMT) airway score. The pharyngeal structures were then evaluated and the best view (lowest class) was recorded. The classification follows m-MMT and is as follows: class 1, full visibility of tonsils, uvula, and soft palate; class 2, visibility of hard and soft palate, upper portion of tonsils and uvula; class 3, visibility of the soft and hard palate and base of the uvula; and class 4, visibility of only the hard palate, class III or IV patients were included in the study. Inhalational anesthesia use maintains the respiratory drive of the patient allowing less stressful technique.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fiberoptic, airway | Active comparator | Device: fiberoptic, airwayClassical fiberoptic intubation assisted by side fenestrated airway and head tilt- chin lift- jaw thrust by 2 anesthetist |
| fiberoptic, Machintosh | Experimental | Device: fiberoptic, Machintoshoral Fiberoptic bronchoscopic intubation assisted by Macintosh Laryngoscope, by 2 anesthetist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with Modified Mallampati (NT-MMT) airway score III,VI
- American Society of Anaesthesiologists (ASA) physical class I-III
- Scheduled for elective cancer surgery under general anesthesia
Key exclusion criteria (7 listed)
- Modified Mallampati I,II Airway scored patients.
- History of upper airway surgery.
- Patients with serious deformities of the mandible, maxilla, tongue, pharynx or larynx.
- Patients with a history of significant cardiac and pulmonary diseases,
- Obesity with BMI >40,
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 |
|---|---|---|
| fiberoptic, airwayclassic fiberoptic bronchoscope, fenstrated airway | Device | fiberoptic, airway |
| fiberoptic, Machintoshoral fiberoptic brochoscopic, Machintosh laryngoscope | Device | fiberoptic, Machintosh |
Primary outcome
intubation time
Time frame: during intubation
time from introduction of the tip of the fiber optic laryngoscope till insertion of the tube in the laryngeal inlet down in the trachea in seconds.
9 secondary outcomes
lower jaw relaxation
Time frame: during intubation
Vocal cord position
Time frame: during intubation
Neck movements
Time frame: during intubation and cuff inflation
Cough
Time frame: during intubation and cuff inflation
1st trial success rate
Time frame: during intubation
the number of trails
Time frame: during intubation
mean arterial Blood pressure (MBP)
Time frame: during intubation till 5 minutes after intubation
mean heart rate (HR)
Time frame: during intubation till 5 minutes after intubation
desaturation (SpO2)
Time frame: during intubation
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 5 Oct 2018.
- Individual participant dataSharing planned: Yes. after publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fiberoptic, airway and fiberoptic, Machintosh in people with Difficult Intubation, run by Mansoura 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 7 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 5 Oct 2018. 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?
intubation time (time frame: during intubation). 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 5 Oct 2018.