Intubation ComplicationNCT05494463
Miller Blade for Intubation in Adults
A study testing Miller blade in people with Intubation Complication, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The study compares laryngeal view obtained with standard Macintosh blade laryngoscope and Miller blade laryngoscope in adult patients. After introduction to general anesthesia anesthesiologist will perform laryngoscopy with one chosen blade and after evaluation of visualisation of entrance to larynx will change blade… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Miller blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,130 participants
- Where
- 1 sitePoland
- Study dates
- 20 May 2022to 1 Feb 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients scheduled for elective procedures under general anesthesia with endotracheal intubation
Who cannot join
- patients with expected difficutl intubation requiring advanced intubation techniques
- with injuries of the cervical spine, or for surgery in the cervical spine
- patients with increased intracranial and intraocular pressure, with vascular changes in the CNS and other parts of the body
- patients with ASA III and above
- patients who do not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Miller Laryngoscope and the Macintosh Laryngoscope During Endotracheal Intubation in Adult Patients
The study compares laryngeal view obtained with standard Macintosh blade laryngoscope and Miller blade laryngoscope in adult patients. After introduction to general anesthesia anesthesiologist will perform laryngoscopy with one chosen blade and after evaluation of visualisation of entrance to larynx will change blade to second one and repeat evaluation.
Read the detailed description
Tracheal intubation is the gold standard of the airway in the operating theater in patients undergoing general anesthesia for surgery, in intensive care and emergency medicine, in patients with severe respiratory failure, which is life-threatening. The laryngoscope is a device used to visualize the entrance to the airway and the subsequent insertion of the tracheal tube into the trachea and main bronchus. Macintosh and Miller laryngoscopes have been used in clinical practice for several decades. The Macintosh laryngoscope is most commonly used for the intubation of adult patients, and the Miller laryngoscope for the intubation of newborns, including premature babies and pediatric patients. Currently, when we are dealing with the sars covid-19 virus epidemic and a large number of patients with respiratory failure requiring endotracheal intubation and replacement ventilation, searching for a device that facilitates endotracheal intubation, especially by people with little experience in using it, in the absence of anesthesiologists, seems to be justified. The aim of the study will be to assess the possibility of using the Miller's laryngoscope for intubation of adult patients and to compare it with the most frequently used Macintosh laryngoscope in this group of patients. The study will include patients scheduled for elective surgery under general endotracheal anesthesia. After a typical induction of anesthesia with the use of short-term intravenous anesthetics, opioids and muscle relaxants, appropriate for the planned surgery and a specific patient, after obtaining complete neuromuscular blockade, a Macintosh laryngoscope will be inserted to perform direct laryngoscopy and assess the exit to the respiratory tract with the help of the Cormack scale. Then the laryngoscope will be removed, the patient will receive active oxygen therapy to increase blood oxygenation to the value of 99-100%, and then an additional dose of intravenous anesthetic will be administered and a second direct laryngoscopy will be performed with the Miller's laryngoscope with a subsequent assessment of airway entry using the scale Cormack. The patient will then be intubated and connected to an anesthesia machine.
- Conditions
- Intubation Complication
- Being tested
- Miller blade
- Keywords
- laryngoscopy, endotracheal intubation, Miller blade, Macintosh blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miller bladeDevice
After laryngoscopy with Macintosh blade patient will be evaluated in laryngoscopy with Miller blade
| Study group | Role | What they receive |
|---|---|---|
| Macintosh blade | No intervention | laryngoscopy with Macintosh blade |
| Miller blade | Active comparator | laryngoscopy with Miller blade in the same patient Receives: Device: Miller blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Grade of view of entrance to larynx
Laryngoscopy with Macintosh blade and then with Miller blade in the same patient, grade of view estimated in Cormack-lehane scale and POGO - percentage of glottis opening
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start20 May 2022
- Primary completion1 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- First laryngoscopy with randomly choosed blade and then laryngoscopy wiht second choosen blade in the same patient
- Masking
- None (open label)
- Enrolment
- 1,130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494463
- Sponsor's protocol ID
- RNN/103/22/KE
- Status last verified
- Jul 2022
- First submitted
- 8 Aug 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ratajczyk P, Kluj P, Szmyd B, Resch J, Hogendorf P, Durczynski A, Gaszynski T. A Comparison of Miller Straight Blade and Macintosh Blade Laryngoscopes for Intubation in Morbidly Obese Patients. J Clin Med. 2024 Jan 24;13(3):681. doi: 10.3390/jcm13030681.
PubMed 38337375
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Miller Laryngoscope and the Macintosh Laryngoscope During Endotracheal Intubation in Adult Patients
- ClinicalTrials.gov ID
- NCT05494463
- Acronym / sponsor ID
- RNN/103/22/KE
- Conditions
- Intubation Complication
- Keywords
- laryngoscopy, endotracheal intubation, Miller blade, Macintosh blade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,130 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 10 Aug 2022 (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.
The study compares laryngeal view obtained with standard Macintosh blade laryngoscope and Miller blade laryngoscope in adult patients. After introduction to general anesthesia anesthesiologist will perform laryngoscopy with one chosen blade and after evaluation of visualisation of entrance to larynx will change blade to second one and repeat evaluation.
Detailed description
Tracheal intubation is the gold standard of the airway in the operating theater in patients undergoing general anesthesia for surgery, in intensive care and emergency medicine, in patients with severe respiratory failure, which is life-threatening. The laryngoscope is a device used to visualize the entrance to the airway and the subsequent insertion of the tracheal tube into the trachea and main bronchus. Macintosh and Miller laryngoscopes have been used in clinical practice for several decades. The Macintosh laryngoscope is most commonly used for the intubation of adult patients, and the Miller laryngoscope for the intubation of newborns, including premature babies and pediatric patients. Currently, when we are dealing with the sars covid-19 virus epidemic and a large number of patients with respiratory failure requiring endotracheal intubation and replacement ventilation, searching for a device that facilitates endotracheal intubation, especially by people with little experience in using it, in the absence of anesthesiologists, seems to be justified. The aim of the study will be to assess the possibility of using the Miller's laryngoscope for intubation of adult patients and to compare it with the most frequently used Macintosh laryngoscope in this group of patients. The study will include patients scheduled for elective surgery under general endotracheal anesthesia. After a typical induction of anesthesia with the use of short-term intravenous anesthetics, opioids and muscle relaxants, appropriate for the planned surgery and a specific patient, after obtaining complete neuromuscular blockade, a Macintosh laryngoscope will be inserted to perform direct laryngoscopy and assess the exit to the respiratory tract with the help of the Cormack scale. Then the laryngoscope will be removed, the patient will receive active oxygen therapy to increase blood oxygenation to the value of 99-100%, and then an additional dose of intravenous anesthetic will be administered and a second direct laryngoscopy will be performed with the Miller's laryngoscope with a subsequent assessment of airway entry using the scale Cormack. The patient will then be intubated and connected to an anesthesia machine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First laryngoscopy with randomly choosed blade and then laryngoscopy wiht second choosen blade in the same patient
| Arm | Type | Receives |
|---|---|---|
| Macintosh blade | No intervention | –laryngoscopy with Macintosh blade |
| Miller blade | Active comparator | Device: Miller bladelaryngoscopy with Miller blade in the same patient |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients scheduled for elective procedures under general anesthesia with endotracheal intubation
Key exclusion criteria (5 listed)
- patients with expected difficutl intubation requiring advanced intubation techniques
- with injuries of the cervical spine, or for surgery in the cervical spine
- patients with increased intracranial and intraocular pressure, with vascular changes in the CNS and other parts of the body
- patients with ASA III and above
- patients who do not consent 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 |
|---|---|---|
| Miller bladeAfter laryngoscopy with Macintosh blade patient will be evaluated in laryngoscopy with Miller blade | Device | Miller blade |
Primary outcome
Number of Grade of view of entrance to larynx
Time frame: immediate
Laryngoscopy with Macintosh blade and then with Miller blade in the same patient, grade of view estimated in Cormack-lehane scale and POGO - percentage of glottis opening
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 6 Jan 2026.
- Derived from this study: PubMed 38337375Ratajczyk P, Kluj P, Szmyd B, Resch J, Hogendorf P, Durczynski A, Gaszynski T. A Comparison of Miller Straight Blade and Macintosh Blade Laryngoscopes for Intubation in Morbidly Obese Patients. J Clin Med. 2024 Jan 24;13(3):681. doi: 10.3390/jcm13030681.
- Individual participant dataSharing planned: Undecided
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Recruiting
The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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 Miller blade in people with Intubation Complication, run by Medical University of Lodz at 1 site in Poland.
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 5 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 6 Jan 2026. 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 Poland. 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?
Number of Grade of view of entrance to larynx (time frame: immediate). 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 NCT05494463, which also lists 1 linked publication.
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 6 Jan 2026.