IntubationNCT04628611
Comparison Between Rigid Video Assisted Laryngoscopy vs Flexible Laryngoscopy in Anticipated Difficult Intubation
A study testing Video laryngoscopy and Flexible intubating laryngoscopy in people with Intubation, run by National Cancer Institute, Egypt.
Trial summary
This is a randomized control study where adult patients had been divided randomly into two equal groups using video laryngoscope in group (V) and flexible intubating laryngoscope in group (F) Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Intubation
- What is being tested?
- Video laryngoscopy and Flexible intubating laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Feb 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- El-Ganzouri score: 2, 3, 4 (Table 1)
- American Society of Anesthesiology (ASA) I, II, III
- Elective surgeries
Who cannot join
- Refusal of participation
- Patients who need a surgical airway (e.g. patients with highly obstructing laryngeal lesions such as cancer tongue, larynx\& maxilla).
- Patients with laryngeal trauma, especially in those with suspected cricotracheal separation.
- Patients with craniofacial trauma.
About this study
This is a randomized control study where adult patients had been divided randomly into two equal groups using video laryngoscope in group (V) and flexible intubating laryngoscope in group (F)
Read the detailed description
Routine pre-operative assessment including history taking, clinical examination, and laboratory tests. Patients were admitted to the operating room with a small 20G IV cannula after applying inclusion \& exclusion criteria and airway assessment by applying El Ganzuri multivariate risk index for difficult intubation which include assessment of the following : inter-incisor gap, Mallampati classification, head \&neck movement, buck teeth prognathism, thyromental distance, body weight and history of difficult intubation.
Operating room was prepared using :
Difficult airway cart that includes different size oral airways, endotracheal tubes, different sizes face masks \& laryngeal airway masks Suction apparatus to be ready for use Video laryngoscopy The flexible intubating laryngoscopy with the tube mounted over the fiberscope before the procedure.
Standard monitoring devices were applied including ECG, non invasive blood pressure. pulse oximetry and capnography after intubation Patients were then pre-oxygenated via face mask for three minutes and using 0.01 mic/kg atropine then general anesthesia is induced using fentanyl 1-2 mic/kg followed by propofol 2 mg/kg and esmeron 0.5 mg/kg.
The patient is mechanically ventilated using face mask until full relaxation is established after 3-5 minutes. The intubation is done using video laryngoscope in group (v) or using flexible intubating laryngoscopy in group (f) In the first group (v) The video laryngoscope was introduced with the patient appropriately positioned, the operator used the left hand to introduce the video laryngoscope into the midline of the Oropharynx and gently advances until the blade tip pass the posterior portion of the tongue. Using video visualization, the ETT was then advanced on a smooth curve through the glottis and intubation proceeds. Viewing the entire insertion step on the video screen allows the operator to quickly become facile with the motion of gently rotating or angling the tube using the right hand to redirect as necessary.
In the second group(f) patients positioned supine with the operator standing at the head of the bed. Simple chin lift and jaw thrust may improve the view through the flexible laryngoscopy and also help to prevent airway obstruction. The endotracheal tube should be lubricant to facilitate its subsequent advancement into the trachea. Once the endotracheal tube is in place, the scope is removed, and the patient is ventilated. Flexible intubating laryngoscopy is often performed with the operator looking through the eyepiece. However, connecting the flexible laryngoscopy to a monitor is often advantageous.
After collecting demographic data of the patient (age, sex, body mass index \& ASA) The following parameters will be measured :
Intubation time, Hemodynamic parameters, success rate and number of attempts \& incidence of complications.
- Conditions
- Intubation
- Being tested
- Video laryngoscopy, Flexible intubating laryngoscopy
- Keywords
- video laryngoscopy, Flexible intubating bronchoscope, Anticipated difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video laryngoscopyDevice
Also called Storz c-mac laryngoscopy
Endotracheal intubation using video laryngoscopy
Flexible intubating laryngoscopyDevice
Also called Storz flexible intubation video endoscope set
Endotracheal intubation using flexible intubating laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Video laryngoscopy Group (V) using Storz c-mac laryngoscope | Active comparator | video laryngoscope without a channel used for endotracheal intubation, the device used to obtain a view of the larynx, and the endotracheal tube is passed through the vocal cords independent of the device. The device is connected to the monitor via connecting cable Receives: Device: Video laryngoscopy |
| The flexible intubating laryngoscopy Group (F) using Storz flexible intubation video endoscope set | Active comparator | The flexible intubating scope is used to locate the vocal cords and acts as a stylet for the endotracheal tube once the scope is placed into the trachea.This device consists of a flexible insertion cord that contains a small camera at the tip, used to transmit images to camera head. The cord includes a channel for a light source, a working channel for suction or administration of oxygen or local anesthetic, and a cable that allows the operator to flex the tip of the scope. The cord attaches to a handle with a light source,camera head control lever for flexion/extension of the tip, and a working channel port. The device is connected to the monitor via connecting table Receives: Device: Flexible intubating laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
time from initiation of intubation (application of the laryngoscope into mouth) to ETCO2 detection from the ETT. In cases with failed intubation it was considered from initiationof intubation till failure. Measured by seconds
Measured: Through study completion (Assessment done at the same time of doing intubation) within 60 seconds
Secondary outcomes (4)
Heart rate
Measured by(beat/ minute). measured during baseline (just before induction of anesthesia), 3 minutes \& 10 minutes after intubation.
Measured: At the same time of doing the intubation within 15 minutes
Number of attempts
Airway instrumentation will be interrupted if oxygen saturation decreases below 92% and patients are ventilated via a face mask. After 3 failed trials the procedure is considered unsuccessful with insertion of classical LMA of appropriate size, correct placement should be confirmed by capnography, manual ventilation with 100% oxygen should be done and awaken the patient
Measured: AT the same time of doing the intubation within 30 minutes
Incidence of complications
sore throat, mucosal or pharyngeal injury, and esophageal intubation, marked desaturation and unsatisfactory blood gases
Measured: From time of intubation till end of surgery and extubation within 10 hours
Blood pressure
Measured by mm/Hg measured during baseline (just before induction of anesthesia), 3 minutes \& 10 minutes after intubation.
Measured: At the same time of intubation within 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Mar 2016
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- Model description
- two equal groups; group (V) using video laryngoscope(53) and group (F) using flexible intubating laryngoscopy(53).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Essam AH Mahran, MD, Study director, Assistant Professor of Anesthesia, ICU, and Pain Management, NCI, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628611
- Sponsor's protocol ID
- IORG000381
- Status last verified
- Nov 2020
- First submitted
- 15 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Rigid Video Assisted Laryngoscopy vs Flexible Laryngoscopy in Anticipated Difficult Intubation
- ClinicalTrials.gov ID
- NCT04628611
- Acronym / sponsor ID
- IORG000381
- Conditions
- Intubation
- Keywords
- video laryngoscopy, Flexible intubating bronchoscope, Anticipated difficult intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 13 Nov 2020 (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 is a randomized control study where adult patients had been divided randomly into two equal groups using video laryngoscope in group (V) and flexible intubating laryngoscope in group (F)
Detailed description
Routine pre-operative assessment including history taking, clinical examination, and laboratory tests. Patients were admitted to the operating room with a small 20G IV cannula after applying inclusion \& exclusion criteria and airway assessment by applying El Ganzuri multivariate risk index for difficult intubation which include assessment of the following : inter-incisor gap, Mallampati classification, head \&neck movement, buck teeth prognathism, thyromental distance, body weight and history of difficult intubation.
Operating room was prepared using :
Difficult airway cart that includes different size oral airways, endotracheal tubes, different sizes face masks \& laryngeal airway masks Suction apparatus to be ready for use Video laryngoscopy The flexible intubating laryngoscopy with the tube mounted over the fiberscope before the procedure.
Standard monitoring devices were applied including ECG, non invasive blood pressure. pulse oximetry and capnography after intubation Patients were then pre-oxygenated via face mask for three minutes and using 0.01 mic/kg atropine then general anesthesia is induced using fentanyl 1-2 mic/kg followed by propofol 2 mg/kg and esmeron 0.5 mg/kg.
The patient is mechanically ventilated using face mask until full relaxation is established after 3-5 minutes. The intubation is done using video laryngoscope in group (v) or using flexible intubating laryngoscopy in group (f) In the first group (v) The video laryngoscope was introduced with the patient appropriately positioned, the operator used the left hand to introduce the video laryngoscope into the midline of the Oropharynx and gently advances until the blade tip pass the posterior portion of the tongue. Using video visualization, the ETT was then advanced on a smooth curve through the glottis and intubation proceeds. Viewing the entire insertion step on the video screen allows the operator to quickly become facile with the motion of gently rotating or angling the tube using the right hand to redirect as necessary.
In the second group(f) patients positioned supine with the operator standing at the head of the bed. Simple chin lift and jaw thrust may improve the view through the flexible laryngoscopy and also help to prevent airway obstruction. The endotracheal tube should be lubricant to facilitate its subsequent advancement into the trachea. Once the endotracheal tube is in place, the scope is removed, and the patient is ventilated. Flexible intubating laryngoscopy is often performed with the operator looking through the eyepiece. However, connecting the flexible laryngoscopy to a monitor is often advantageous.
After collecting demographic data of the patient (age, sex, body mass index \& ASA) The following parameters will be measured :
Intubation time, Hemodynamic parameters, success rate and number of attempts \& incidence of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two equal groups; group (V) using video laryngoscope(53) and group (F) using flexible intubating laryngoscopy(53).
| Arm | Type | Receives |
|---|---|---|
| Video laryngoscopy Group (V) using Storz c-mac laryngoscope | Active comparator | Device: Video laryngoscopyvideo laryngoscope without a channel used for endotracheal intubation, the device used to obtain a view of the larynx, and the endotracheal tube is passed through the vocal cords independent of the device. The device is connected to the monitor via connecting cable |
| The flexible intubating laryngoscopy Group (F) using Storz flexible intubation video endoscope set | Active comparator | Device: Flexible intubating laryngoscopyThe flexible intubating scope is used to locate the vocal cords and acts as a stylet for the endotracheal tube once the scope is placed into the trachea.This device consists of a flexible insertion cord that contains a small camera at the tip, used to transmit images to camera head. The cord includes a channel for a light source, a working channel for suction or administration of oxygen or local anesthetic, and a cable that allows the operator to flex the tip of the scope. The cord attaches to a handle with a light source,camera head control lever for flexion/extension of the tip, and a working channel port. The device is connected to the monitor via connecting table |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- El-Ganzouri score: 2, 3, 4 (Table 1)
- American Society of Anesthesiology (ASA) I, II, III
- Elective surgeries
Key exclusion criteria (4 listed)
- Refusal of participation
- Patients who need a surgical airway (e.g. patients with highly obstructing laryngeal lesions such as cancer tongue, larynx\& maxilla).
- Patients with laryngeal trauma, especially in those with suspected cricotracheal separation.
- Patients with craniofacial trauma.
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 |
|---|---|---|
| Video laryngoscopyAlso: Storz c-mac laryngoscopyEndotracheal intubation using video laryngoscopy | Device | Video laryngoscopy Group (V) using Storz c-mac laryngoscope |
| Flexible intubating laryngoscopyAlso: Storz flexible intubation video endoscope setEndotracheal intubation using flexible intubating laryngoscope | Device | The flexible intubating laryngoscopy Group (F) using Storz flexible intubation video endoscope set |
Primary outcome
Intubation time
Time frame: Through study completion (Assessment done at the same time of doing intubation) within 60 seconds
time from initiation of intubation (application of the laryngoscope into mouth) to ETCO2 detection from the ETT. In cases with failed intubation it was considered from initiationof intubation till failure. Measured by seconds
4 secondary outcomes
Heart rate
Time frame: At the same time of doing the intubation within 15 minutes
Number of attempts
Time frame: AT the same time of doing the intubation within 30 minutes
Incidence of complications
Time frame: From time of intubation till end of surgery and extubation within 10 hours
Blood pressure
Time frame: At the same time of intubation within 15 minutes
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 13 Nov 2020.
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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.
Essam AH Mahran, MD study director
Assistant Professor of Anesthesia, ICU, and Pain Management, NCI, Cairo
Questions about this trial
What is this clinical trial studying?
A study testing Video laryngoscopy and Flexible intubating laryngoscopy in people with Intubation, run by National Cancer Institute, 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 13 Nov 2020. 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?
Intubation time (time frame: Through study completion (Assessment done at the same time of doing intubation) within 60 seconds). 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 13 Nov 2020.