Airway ManagementNCT04850976
Self-Assembled Modified Macintosh Videolaryngoscope Versus McGrath Macintosh (MAC®) Videolaryngoscope: Which is Better?
A study testing Endotracheal intubation in people with Airway Management, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Videolaryngoscopy highly improves success rate for endotracheal intubation in both normal and difficult airway. However, commercially available videolaryngoscope such as McGrath MAC® can be costly. The. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2020to 31 Aug 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adult patients (18-65 years old), American Society of Anesthesiologists (ASA) physical status of I - II, Body Mass Index (BMI) of 18 - 30 kg/m2, scheduled for elective surgical procedures under general anesthesia
Who cannot join
- ASA III or above, difficult airway, pregnancy, cardiac condition, neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
University of Indonesia and Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Videolaryngoscopy highly improves success rate for endotracheal intubation in both normal and difficult airway. However, commercially available videolaryngoscope such as McGrath MAC® can be costly.
The. investigators aim to study a more economical alternative by comparing the intubation time, first attempt success rate, laryngeal visualization, complications, and user satisfaction between our self-assembled modified macintosh videolaryngoscope (SAM-VL) and McGrath MAC® (McGrath).
The study shows that endotracheal intubation using self-assembled modified videolaryngoscope is faster, had more successful first attempts, and allowed better glottis visualization compared with McGrath MAC®. It is a suitable alternative for videolaryngoscope in low resource setting.
Read the detailed description
Background and Aims: Videolaryngoscopy highly improves success rate for endotracheal intubation in both normal and difficult airway. However, commercially available videolaryngoscope such as McGrath MAC® can be costly. The investigators aim to study a more economical alternative by comparing the intubation time, first attempt success rate, laryngeal visualization, complications, and user satisfaction between our self-assembled modified macintosh videolaryngoscope (SAM-VL) and McGrath MAC® (McGrath).
Settings and Design: This was a single-blind randomized clinical trial with 62 adult subjects. The investigators exclude patients with difficult airway, cardiac disease, and neuromuscular disease. The results were calculated using the Statistical Package for Social Scientists (SPSS) 24 Results: Median total intubation time was 63 s (27 - 114 s) in SAM-VL group, compared with 74 s (40 - 133 s), (p = 0,032) in McGrath group. The rate of successful first attempt in SAM-VL group was slightly higher than McGrath group at 90,3% vs 87.1%. Glottic visualization was more satisfactory in SAM-VL group with 67.7% of subjects having score of 100 and 29% of subject having score of 75. Complications found in this study were tachycardia (12.9% SAM-VL group vs 29% in McGrath group) and minimal airway mucosal laceration (9.7% in SAM-VL vs 3.2% in McGrath group). SAM-VL users rate the device high in ease of blade insertion and manoeuvrability, providing good laryngeal visualisation, and overall satisfaction rating.
Conclusions: Endotracheal intubation using self-assembled modified videolaryngoscope is faster, had more successful first attempts, and allowed better glottis visualization compared with McGrath MAC®.
Key-words: endotracheal intubation, self-assembled videolaryngoscope, McGrath MAC®, intubation time, glottis visualization Key Messages: Endotracheal intubation using self-assembled modified videolaryngoscope is faster, had more successful first attempts, and allowed better glottis visualization compared with McGrath MAC®. It is a suitable alternative for videolaryngoscope in low resource setting.
- Conditions
- Airway Management
- Being tested
- Endotracheal intubation
- Keywords
- endotracheal intubation, self-assembled videolaryngoscope, McGrath MAC®, intubation time, glottis visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationDevice
Every eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation
| Study group | Role | What they receive |
|---|---|---|
| Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group | Experimental | The self-assembled modified Macintosh videolaryngoscope (SAM-VL) used in this study was constructed from a portable video camera with Wi-fi connection (Wi-fi Endoscope Video Camera model YPC99) attached to a no. 4 Macintosh Laryngoscope blade (Riester® no.7040). The video signal is transmitted to an Android-based mobile phone (Android version 7.0). The portable 2 megapixels video camera is 8 mm in diameter with 8 Light Emitting Diode (LED) lights for adjustable lighting level and 3 meters cable length. Video resolution output is 640x480 pixels (VGA) and 1280x720 pixels (HD). The camera has 70º visual angle with focus length of 4- 6cm and is water-resistant. The camera was taped to the Macintosh blade at a distance of 5 cm from the distal end of the blade, using transparent waterproof Leukofix® tape. Receives: Device: Endotracheal intubation |
| McGrath MAC® videolaryngoscope (McGrath) group | Active comparator | The McGrath MAC® videolaryngoscope used in this study was equipped with disposable blade no.4 Receives: Device: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time needed for Intubation "A"
The time needed for Intubation "A" recording began when the tip of the laryngoscope blade passed through the incisors until the operator was able to achieve best visualization of the glottis. Measured in seconds (s).
Measured: After endotracheal intubation completed
Time needed for Intubation "B"
The time needed for Intubation"B" recording began when the operator received visualization of the glottis and ended after the endotracheal tube tube was confirmed to enter the trachea. Measured in seconds (s).
Measured: After the endotracheal intubation completed
Total time needed for intubation
The sum total of time needed for Intubation A+B. Measured in seconds (s).
Measured: After the endotracheal intubation completed
Secondary outcomes (4)
Successful first attempt
Measuring intubation's first attempt success rate between the two groups. Success rate defined in number (%).
Measured: After the endotracheal intubation completed
Laryngeal visualization
Measuring laryngeal visualization using Percentage of Glottic Opening (POGO) score: 100,75, 50, 25, 0.
Measured: After the endotracheal intubation completed
Complications
Documenting complications generated by each device. Complications recorded are: Hypertension, hypotension, tachycardia, bradycardia, mucosal laceration, and esophageal intubation. Incidence are presented in numbers (%).
Measured: After the endotracheal intubation completed
Laryngoscope User Satisfaction
Documenting laryngoscope user satisfaction in terms of blade insertion (very easy, easy, reasonable, difficult), device maneuverability (very easy, easy, reasonable, difficult), glottic visualization (very good, good, enough, poor), and overall satisfaction rating (very good, good, enough, poor).
Measured: After the endotracheal intubation completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Jun 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Model description
- There were 2 intervention groups: (1) the Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group or (2) the McGrath MAC ® videolaryngoscope (McGrath) group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raden Besthadi Sukmono, Universitas Indonesia
- Investigators
- Besthadi Sukmono, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850976
- Sponsor's protocol ID
- IndonesiaUniv
- Status last verified
- May 2021
- First submitted
- 8 Apr 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Statistical Analysis Plan
Publications
Griesdale DE, Bosma TL, Kurth T, Isac G, Chittock DR. Complications of endotracheal intubation in the critically ill. Intensive Care Med. 2008 Oct;34(10):1835-42. doi: 10.1007/s00134-008-1205-6. Epub 2008 Jul 5.
PubMed 18604519Rosenblatt WH, Sukhupragarn W. Airway management. In: Barash PG, editor. Barash Clinical Anesthesia, 7th ed. Philadelphia:Lippincott William & Wilkins. 2013;27:763-778.
Shin M, Bai SJ, Lee KY, Oh E, Kim HJ. Comparing McGRATH(R) MAC, C-MAC(R), and Macintosh Laryngoscopes Operated by Medical Students: A Randomized, Crossover, Manikin Study. Biomed Res Int. 2016;2016:8943931. doi: 10.1155/2016/8943931. Epub 2016 Sep 15.
PubMed 27703983Liu ZJ, Yi J, Guo WJ, Ma C, Huang YG. Comparison of McGrath Series 3 and Macintosh Laryngoscopes for Tracheal Intubation in Patients With Normal Airway by Inexperienced Anesthetists: A Randomized Study. Medicine (Baltimore). 2016 Jan;95(2):e2514. doi: 10.1097/MD.0000000000002514.
PubMed 26765472Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC((R)) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4.
PubMed 26336853Normand KC, Vargas LA, Burnett T, Sridhar S, Cai C, Zhang X, et al. Use of the McGRATH TM MAC : To view or not to view ?
Ng I, Hill AL, Williams DL, Lee K, Segal R. Randomized controlled trial comparing the McGrath videolaryngoscope with the C-MAC videolaryngoscope in intubating adult patients with potential difficult airways. Br J Anaesth. 2012 Sep;109(3):439-43. doi: 10.1093/bja/aes145. Epub 2012 Jun 7.
PubMed 22677878Thong S, Teoh WH. Videolaryngoscopy and Indirect Intubating Aids in Airway Management. In: Khan Z, editor. Airway Management. 1st ed. Springer International Publishing Switzerland; 2014. p. 25-63
Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
PubMed 19399574Karippacheril JG, Umesh G, Ramkumar V. Inexpensive video-laryngoscopy guided intubation using a personal computer: initial experience of a novel technique. J Clin Monit Comput. 2014 Jun;28(3):261-4. doi: 10.1007/s10877-013-9522-x. Epub 2013 Oct 17.
PubMed 24132806Latuconsina FW, Dedi Fitri Yadi S. Perbandingan intubasi endotrakea menggunakan clip-on smartphone camera videolaryngoscope dengan laringoskop Macintosh pada manekin. J Anestesi Perioper [Internet]. 2018;6(1):27-33
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Assembled Modified Macintosh Videolaryngoscope Versus McGrath Macintosh (MAC®) Videolaryngoscope: Which is Better?
- ClinicalTrials.gov ID
- NCT04850976
- Acronym / sponsor ID
- IndonesiaUniv
- Conditions
- Airway Management
- Keywords
- endotracheal intubation, self-assembled videolaryngoscope, McGrath MAC®, intubation time, glottis visualization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 20 Apr 2021 (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.
Videolaryngoscopy highly improves success rate for endotracheal intubation in both normal and difficult airway. However, commercially available videolaryngoscope such as McGrath MAC® can be costly.
The. investigators aim to study a more economical alternative by comparing the intubation time, first attempt success rate, laryngeal visualization, complications, and user satisfaction between our self-assembled modified macintosh videolaryngoscope (SAM-VL) and McGrath MAC® (McGrath).
The study shows that endotracheal intubation using self-assembled modified videolaryngoscope is faster, had more successful first attempts, and allowed better glottis visualization compared with McGrath MAC®. It is a suitable alternative for videolaryngoscope in low resource setting.
Detailed description
Background and Aims: Videolaryngoscopy highly improves success rate for endotracheal intubation in both normal and difficult airway. However, commercially available videolaryngoscope such as McGrath MAC® can be costly. The investigators aim to study a more economical alternative by comparing the intubation time, first attempt success rate, laryngeal visualization, complications, and user satisfaction between our self-assembled modified macintosh videolaryngoscope (SAM-VL) and McGrath MAC® (McGrath).
Settings and Design: This was a single-blind randomized clinical trial with 62 adult subjects. The investigators exclude patients with difficult airway, cardiac disease, and neuromuscular disease. The results were calculated using the Statistical Package for Social Scientists (SPSS) 24 Results: Median total intubation time was 63 s (27 - 114 s) in SAM-VL group, compared with 74 s (40 - 133 s), (p = 0,032) in McGrath group. The rate of successful first attempt in SAM-VL group was slightly higher than McGrath group at 90,3% vs 87.1%. Glottic visualization was more satisfactory in SAM-VL group with 67.7% of subjects having score of 100 and 29% of subject having score of 75. Complications found in this study were tachycardia (12.9% SAM-VL group vs 29% in McGrath group) and minimal airway mucosal laceration (9.7% in SAM-VL vs 3.2% in McGrath group). SAM-VL users rate the device high in ease of blade insertion and manoeuvrability, providing good laryngeal visualisation, and overall satisfaction rating.
Conclusions: Endotracheal intubation using self-assembled modified videolaryngoscope is faster, had more successful first attempts, and allowed better glottis visualization compared with McGrath MAC®.
Key-words: endotracheal intubation, self-assembled videolaryngoscope, McGrath MAC®, intubation time, glottis visualization Key Messages: Endotracheal intubation using self-assembled modified videolaryngoscope is faster, had more successful first attempts, and allowed better glottis visualization compared with McGrath MAC®. It is a suitable alternative for videolaryngoscope in low resource setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- There were 2 intervention groups: (1) the Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group or (2) the McGrath MAC ® videolaryngoscope (McGrath) group.
| Arm | Type | Receives |
|---|---|---|
| Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group | Experimental | Device: Endotracheal intubationThe self-assembled modified Macintosh videolaryngoscope (SAM-VL) used in this study was constructed from a portable video camera with Wi-fi connection (Wi-fi Endoscope Video Camera model YPC99) attached to a no. 4 Macintosh Laryngoscope blade (Riester® no.7040). The video signal is transmitted to an Android-based mobile phone (Android version 7.0). The portable 2 megapixels video camera is 8 mm in diameter with 8 Light Emitting Diode (LED) lights for adjustable lighting level and 3 meters cable length. Video resolution output is 640x480 pixels (VGA) and 1280x720 pixels (HD). The camera has 70º visual angle with focus length of 4- 6cm and is water-resistant. The camera was taped to the Macintosh blade at a distance of 5 cm from the distal end of the blade, using transparent waterproof Leukofix® tape. |
| McGrath MAC® videolaryngoscope (McGrath) group | Active comparator | Device: Endotracheal intubationThe McGrath MAC® videolaryngoscope used in this study was equipped with disposable blade no.4 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (18-65 years old), American Society of Anesthesiologists (ASA) physical status of I - II, Body Mass Index (BMI) of 18 - 30 kg/m2, scheduled for elective surgical procedures under general anesthesia
Key exclusion criteria (1 listed)
- ASA III or above, difficult airway, pregnancy, cardiac condition, neuromuscular disease
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 intubationEvery eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation | Device | McGrath MAC® videolaryngoscope (McGrath) group, Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group |
Primary outcome
Time needed for Intubation "A"
Time frame: After endotracheal intubation completed
The time needed for Intubation "A" recording began when the tip of the laryngoscope blade passed through the incisors until the operator was able to achieve best visualization of the glottis. Measured in seconds (s).
Time needed for Intubation "B"
Time frame: After the endotracheal intubation completed
The time needed for Intubation"B" recording began when the operator received visualization of the glottis and ended after the endotracheal tube tube was confirmed to enter the trachea. Measured in seconds (s).
Total time needed for intubation
Time frame: After the endotracheal intubation completed
The sum total of time needed for Intubation A+B. Measured in seconds (s).
4 secondary outcomes
Successful first attempt
Time frame: After the endotracheal intubation completed
Laryngeal visualization
Time frame: After the endotracheal intubation completed
Complications
Time frame: After the endotracheal intubation completed
Laryngoscope User Satisfaction
Time frame: After the endotracheal intubation completed
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 May 2021.
- Background: PubMed 18604519Griesdale DE, Bosma TL, Kurth T, Isac G, Chittock DR. Complications of endotracheal intubation in the critically ill. Intensive Care Med. 2008 Oct;34(10):1835-42. doi: 10.1007/s00134-008-1205-6. Epub 2008 Jul 5.
- BackgroundRosenblatt WH, Sukhupragarn W. Airway management. In: Barash PG, editor. Barash Clinical Anesthesia, 7th ed. Philadelphia:Lippincott William & Wilkins. 2013;27:763-778.
- Background: PubMed 27703983Shin M, Bai SJ, Lee KY, Oh E, Kim HJ. Comparing McGRATH(R) MAC, C-MAC(R), and Macintosh Laryngoscopes Operated by Medical Students: A Randomized, Crossover, Manikin Study. Biomed Res Int. 2016;2016:8943931. doi: 10.1155/2016/8943931. Epub 2016 Sep 15.
- Background: PubMed 26765472Liu ZJ, Yi J, Guo WJ, Ma C, Huang YG. Comparison of McGrath Series 3 and Macintosh Laryngoscopes for Tracheal Intubation in Patients With Normal Airway by Inexperienced Anesthetists: A Randomized Study. Medicine (Baltimore). 2016 Jan;95(2):e2514. doi: 10.1097/MD.0000000000002514.
- Background: PubMed 26336853Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC((R)) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4.
- BackgroundNormand KC, Vargas LA, Burnett T, Sridhar S, Cai C, Zhang X, et al. Use of the McGRATH TM MAC : To view or not to view ?
- Background: PubMed 22677878Ng I, Hill AL, Williams DL, Lee K, Segal R. Randomized controlled trial comparing the McGrath videolaryngoscope with the C-MAC videolaryngoscope in intubating adult patients with potential difficult airways. Br J Anaesth. 2012 Sep;109(3):439-43. doi: 10.1093/bja/aes145. Epub 2012 Jun 7.
- BackgroundThong S, Teoh WH. Videolaryngoscopy and Indirect Intubating Aids in Airway Management. In: Khan Z, editor. Airway Management. 1st ed. Springer International Publishing Switzerland; 2014. p. 25-63
- Background: PubMed 19399574Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
- Background: PubMed 24132806Karippacheril JG, Umesh G, Ramkumar V. Inexpensive video-laryngoscopy guided intubation using a personal computer: initial experience of a novel technique. J Clin Monit Comput. 2014 Jun;28(3):261-4. doi: 10.1007/s10877-013-9522-x. Epub 2013 Oct 17.
- BackgroundLatuconsina FW, Dedi Fitri Yadi S. Perbandingan intubasi endotrakea menggunakan clip-on smartphone camera videolaryngoscope dengan laringoskop Macintosh pada manekin. J Anestesi Perioper [Internet]. 2018;6(1):27-33
- Xue FS, Li HX, Liu YY, Yang GZ. Current evidence for the use of C-MAC videolaryngoscope in adult airway management: A review of the literature. Ther Clin Risk Manag \[Internet\]. 2017;13:831-41Link provided by the sponsor.
- Walker L, Brampton W, Halai M, Hoy C, Lee E, Scott I, et al. Randomized controlled trial of intubation with the McGrath w Series 5 videolaryngoscope by inexperienced anaesthetists. Br J Anaesth \[Internet\]. 2009;103(3):440-5.Link provided by the sponsor.
- Levitan RM, Heitz JW, Sweeney M, Cooper RM. The Complexities of Tracheal Intubation With Direct Laryngoscopy and Alternative Intubation Devices. YMEM \[Internet\]. 2011;57(3):240-7.Link provided by the sponsor.
- Luqmanmuhamed M, Devadas P. Comparison between custom made video laryngoscope and Macintosh laryngoscope aided endotracheal intubation : a simple and inexpensive digital tool. IOSR J Dent Med Sci \[Internet\]. 2017;16(9):45-51.Link provided by the sponsor.
- Hoshijima H, Mihara T, Maruyama K, Denawa Y, Takahashi M, Shiga T, et al. McGrath videolaryngoscope versus Macintosh laryngoscope for tracheal intubation: A systematic review and meta-analysis with trial sequential analysis. J Clin Anesth \[Internet\].Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study Protocol and Statistical Analysis Plan
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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.
Besthadi Sukmono, MD principal investigator
Universitas Indonesia
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 intubation in people with Airway Management, run by Universitas Indonesia at 1 site in Indonesia.
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 1 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 May 2021. 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 Indonesia. 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?
Time needed for Intubation "A" (time frame: After endotracheal intubation completed). The study lists 3 primary outcomes in all. 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 NCT04850976, which also lists 11 linked publications.
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 May 2021.