Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence InductionNCT03912935
Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction.
A study testing comparison between two different intubating position in people with Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study is aimed to conduct a randomised controlled trial comparing endotracheal intubation (ETI) in bed up head elevation BUHE position versus sniffing position in simulated rapid sequence induction (RSI). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction
- What is being tested?
- comparison between two different intubating position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMalaysia
- Study dates
- 24 Aug 2018to 30 Jun 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old.
Who cannot join
- Patients with airway obstruction
- Patients with contraindication to neck extension
- BMI> 35kg/m2
- Patient with history of difficult airway from previous intubation history
- Only single intubation will be included if patients had multiple surgery during their hospital stay
- Patients with ischaemic heart disease, cerebrovascular diseases and respiratory disease
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Shahmini Ganesh, MD, 0379492052, shahminig2805@gmail.com
Samuel Tsan Ern Hung, MD, 0379492052, samuel.tsan@gmail.com
About this study
Official title: Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial
This study is aimed to conduct a randomised controlled trial comparing endotracheal intubation (ETI) in bed up head elevation BUHE position versus sniffing position in simulated rapid sequence induction (RSI).
Objective is to determine if the time taken for intubation in the bed up head elevated position is non-inferior to time taken for intubation in the sniffing position.
Read more
The hypotheses:
- In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position is non inferior to time required for DL and successful ETI in the sniffing position.
- In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position improve POGO score.
- In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position reduces airway related complications.
Terminology:
Direct laryngoscopy (DL) and Endotracheal intubation (ETI): Is a method of inserting a breathing tube into the trachea (windpipe) once patient undergo general anaesthesia.
Bed up head elevation (BUHE): Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch.
Sniffing position: Maintaining supine position with head elevation with head rest.
Rapid sequence induction (RSI): An established method of inducing anaesthesia in patients who are at risk of aspiration of gastric contents into the lungs. It involves loss of consciousness during cricoid pressure followed by intubation without face mask ventilation. The aim is to intubate the trachea as quickly and as safely as possible.
POGO score: Percentage of glottic opening
Cricoid Pressure (CP): Maneuvre to prevent regurgitation of gastric contents during induction of anaesthesia by temporary occlusion of the upper end of the esophagus by backward pressure of cricoid cartilage against bodies of cervical vertebrae.
Read the detailed description
All patients from age 18 years old to 75 years old undergoing elective surgery under general anaesthesia in operating theater of University Malaya Medical Centre over a period of 15 months, from April 2018 to June 2019 will be included and recruited based on inclusion and exclusion criteria.
Those patient that fulfilled the criteria and consented for the study will be randomized to 2 group.
- BUHE group: Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch. ii) Sniffing group: Maintaining supine position with head elevation with head rest (foam donut).
Induction of anaesthesia starts with:
- preoxygenation with 100% oxygen for 3-5 min performed until end tidal oxygen of 85% achieved.
- A pre-calculated dose of induction agent is administered, followed immediately by a neuromuscular blocking agent. (IV Fentanyl 2mcg/kg,IV Propofol 2-3mg/kg,IV Rocuronium 1mg/kg).
- Cricoid pressure at 10 Newton is applied increasing to 30 Newton once consciousness is lost.
- After adequate neuromuscular blockade,both group patients will be intubated by one investigator via direct laryngoscopy using Macintosh blade size 3 or 4.
- Time taken from insertion of Macintosh blade into oral cavity till confirmation of endotracheal tube placement via detection of CO2 on the end tidal CO2 monitor will be recorded.
- Being tested
- comparison between two different intubating position
- Keywords
- Rapid sequence induction, Bed up head elevation, sniffing position, cricoid pressure, time taken for intubation in seconds, percentage of glottic opening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison between two different intubating positionOther
Comparing to different position (sniffing and BUHE) in endotracheal intubation for rapid sequence induction in simulated emergency cases
| Study group | Role | What they receive |
|---|---|---|
| Sniffing position | No intervention | Subject will be maintained in standard intubation position which is supine position with head elevation with head rest (foam donut). |
| Bed up head elevation position | Experimental | Subject will be maintained at bed up 20-30 degree aiming alignment between the external auditory meatus with sternal notch Receives: Other: comparison between two different intubating position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
Measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
Measured: Intraoperatively , during induction of anaesthesia
Secondary outcomes (7)
Number of laryngoscopy and intubation attempt
Number of attempts taken by investigator to obtain successful endotracheal intubation in both arms
Measured: Intraoperatively , during induction of anaesthesia
Laryngeal exposure measured via POGO score
Percentage of glottic opening during laryngoscopy
Measured: Intraoperatively , during induction of anaesthesia
Occurrence of difficult intubation
Defined as ≥3 attempts at intubation
Measured: Intraoperatively , during induction of anaesthesia
Occurrence of hypoxia
Hypoxia defined as pulse oximetry reading less than 95 percents
Measured: Intraoperatively , during induction of anaesthesia
The use of any other airway adjunct or external laryngeal manipulation to assist in intubation
Change of blade size, bougie, magill forcep, video assisted laryngoscope,external laryngeal manipulation (Use of any airway adjunct is grouped as one)
Measured: Intraoperatively , during induction of anaesthesia
Occurrence of esophageal intubation
Unsuccessful intubation into esophagus
Measured: Intraoperatively , during induction of anaesthesia
Occurrence of airway trauma
broken tooth, bleeding or injury from oral cavity, tongue or lips, etc
Measured: Intraoperatively , during induction of anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start24 Aug 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence InductionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old selected. * Written informed consent will be obtained prior to enrolment. * Randomisation into 2 groups (BUHE and sniffing position) will be done via computer generated sequences. Subsequently, will be placed into sealed envelopes. * The next available envelope will be selected and open for that particular patient at the time of enrolment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Shahmini a/p Ganesh, University of Malaya
- Investigators
- Shahmini Ganesh, MD, Principal investigator, UMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912935
- Sponsor's protocol ID
- MREC ID NO: 2018222-6042
- Status last verified
- Apr 2019
- First submitted
- 9 Mar 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data that already summarized and analysed in the form of schematic diagram will be available to other researchers
Publications
Brodsky JB. Positioning the morbidly obese patient for anesthesia. Obes Surg. 2002 Dec;12(6):751-8. doi: 10.1381/096089202320995510.
PubMed 12568178SELLICK BA. Cricoid pressure to control regurgitation of stomach contents during induction of anaesthesia. Lancet. 1961 Aug 19;2(7199):404-6. doi: 10.1016/s0140-6736(61)92485-0. No abstract available.
PubMed 13749923Vanner RG, Pryle BJ. Nasogastric tubes and cricoid pressure. Anaesthesia. 1993 Dec;48(12):1112-3. doi: 10.1111/j.1365-2044.1993.tb07560.x. No abstract available.
PubMed 8068068Smith KJ, Ladak S, Choi PT, Dobranowski J. The cricoid cartilage and the esophagus are not aligned in close to half of adult patients. Can J Anaesth. 2002 May;49(5):503-7. doi: 10.1007/BF03017931.
PubMed 11983669Rice MJ, Mancuso AA, Gibbs C, Morey TE, Gravenstein N, Deitte LA. Cricoid pressure results in compression of the postcricoid hypopharynx: the esophageal position is irrelevant. Anesth Analg. 2009 Nov;109(5):1546-52. doi: 10.1213/ane.0b013e3181b05404.
PubMed 19843793Robinson JS, Thompson JM. Fatal aspiration (Mendelson's) syndrome despite antacids and cricoid pressure. Lancet. 1979 Aug 4;2(8136):228-30. doi: 10.1016/s0140-6736(79)90240-x.
PubMed 89335Williamson R. Cricoid pressure. Can J Anaesth. 1989 Sep;36(5):601. doi: 10.1007/BF03005396. No abstract available.
PubMed 2791184Kluger MT, Short TG. Aspiration during anaesthesia: a review of 133 cases from the Australian Anaesthetic Incident Monitoring Study (AIMS). Anaesthesia. 1999 Jan;54(1):19-26. doi: 10.1046/j.1365-2044.1999.00642.x.
PubMed 10209365Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. Anesthesiology. 1995 Feb;82(2):367-76. doi: 10.1097/00000542-199502000-00007.
PubMed 7856895Thibodeau LG, Verdile VP, Bartfield JM. Incidence of aspiration after urgent intubation. Am J Emerg Med. 1997 Oct;15(6):562-5. doi: 10.1016/s0735-6757(97)90157-1.
PubMed 9337361Tomkinson J, Turnbull A, Robson G, Cloake E, Adelstein AM, Weatherall J. Report on confidential enquiries into maternal deaths in England and Wales 1973-1975. Rep Health Soc Subj (Lond). 1979;14:1-166. No abstract available.
PubMed 493710Guirro UB, Martins CR, Munechika M. Assessment of anesthesiologists' rapid sequence induction technique in an university hospital. Rev Bras Anestesiol. 2012 May-Jun;62(3):335-45. doi: 10.1016/S0034-7094(12)70134-4.
PubMed 22656679Schmidt A, Akeson J. Practice and knowledge of cricoid pressure in southern Sweden. Acta Anaesthesiol Scand. 2001 Nov;45(10):1210-4. doi: 10.1034/j.1399-6576.2001.451006.x.
PubMed 11736671Brimacombe J, White A, Berry A. Effect of cricoid pressure on ease of insertion of the laryngeal mask airway. Br J Anaesth. 1993 Dec;71(6):800-2. doi: 10.1093/bja/71.6.800.
PubMed 8280541Vanner RG, Clarke P, Moore WJ, Raftery S. The effect of cricoid pressure and neck support on the view at laryngoscopy. Anaesthesia. 1997 Sep;52(9):896-900. doi: 10.1111/j.1365-2044.1997.181-az0315.x.
PubMed 9349075
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03912935
- Acronym / sponsor ID
- MREC ID NO: 2018222-6042
- Keywords
- Rapid sequence induction, Bed up head elevation, sniffing position, cricoid pressure, time taken for intubation in seconds, percentage of glottic opening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 11 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 is aimed to conduct a randomised controlled trial comparing endotracheal intubation (ETI) in bed up head elevation BUHE position versus sniffing position in simulated rapid sequence induction (RSI).
Objective is to determine if the time taken for intubation in the bed up head elevated position is non-inferior to time taken for intubation in the sniffing position.
The hypotheses:
- In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position is non inferior to time required for DL and successful ETI in the sniffing position.
- In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position improve POGO score.
- In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position reduces airway related complications.
Terminology:
Direct laryngoscopy (DL) and Endotracheal intubation (ETI): Is a method of inserting a breathing tube into the trachea (windpipe) once patient undergo general anaesthesia.
Bed up head elevation (BUHE): Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch.
Sniffing position: Maintaining supine position with head elevation with head rest.
Rapid sequence induction (RSI): An established method of inducing anaesthesia in patients who are at risk of aspiration of gastric contents into the lungs. It involves loss of consciousness during cricoid pressure followed by intubation without face mask ventilation. The aim is to intubate the trachea as quickly and as safely as possible.
POGO score: Percentage of glottic opening
Cricoid Pressure (CP): Maneuvre to prevent regurgitation of gastric contents during induction of anaesthesia by temporary occlusion of the upper end of the esophagus by backward pressure of cricoid cartilage against bodies of cervical vertebrae.
Detailed description
All patients from age 18 years old to 75 years old undergoing elective surgery under general anaesthesia in operating theater of University Malaya Medical Centre over a period of 15 months, from April 2018 to June 2019 will be included and recruited based on inclusion and exclusion criteria.
Those patient that fulfilled the criteria and consented for the study will be randomized to 2 group.
- BUHE group: Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch. ii) Sniffing group: Maintaining supine position with head elevation with head rest (foam donut).
Induction of anaesthesia starts with:
- preoxygenation with 100% oxygen for 3-5 min performed until end tidal oxygen of 85% achieved.
- A pre-calculated dose of induction agent is administered, followed immediately by a neuromuscular blocking agent. (IV Fentanyl 2mcg/kg,IV Propofol 2-3mg/kg,IV Rocuronium 1mg/kg).
- Cricoid pressure at 10 Newton is applied increasing to 30 Newton once consciousness is lost.
- After adequate neuromuscular blockade,both group patients will be intubated by one investigator via direct laryngoscopy using Macintosh blade size 3 or 4.
- Time taken from insertion of Macintosh blade into oral cavity till confirmation of endotracheal tube placement via detection of CO2 on the end tidal CO2 monitor will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old selected. * Written informed consent will be obtained prior to enrolment. * Randomisation into 2 groups (BUHE and sniffing position) will be done via computer generated sequences. Subsequently, will be placed into sealed envelopes. * The next available envelope will be selected and open for that particular patient at the time of enrolment.
| Arm | Type | Receives |
|---|---|---|
| Sniffing position | No intervention | –Subject will be maintained in standard intubation position which is supine position with head elevation with head rest (foam donut). |
| Bed up head elevation position | Experimental | Other: comparison between two different intubating positionSubject will be maintained at bed up 20-30 degree aiming alignment between the external auditory meatus with sternal notch |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old.
Key exclusion criteria (6 listed)
- Patients with airway obstruction
- Patients with contraindication to neck extension
- BMI> 35kg/m2
- Patient with history of difficult airway from previous intubation history
- Only single intubation will be included if patients had multiple surgery during their hospital stay
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 |
|---|---|---|
| comparison between two different intubating positionComparing to different position (sniffing and BUHE) in endotracheal intubation for rapid sequence induction in simulated emergency cases | Other | Bed up head elevation position |
Primary outcome
Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
Time frame: Intraoperatively , during induction of anaesthesia
Measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
7 secondary outcomes
Number of laryngoscopy and intubation attempt
Time frame: Intraoperatively , during induction of anaesthesia
Laryngeal exposure measured via POGO score
Time frame: Intraoperatively , during induction of anaesthesia
Occurrence of difficult intubation
Time frame: Intraoperatively , during induction of anaesthesia
Occurrence of hypoxia
Time frame: Intraoperatively , during induction of anaesthesia
The use of any other airway adjunct or external laryngeal manipulation to assist in intubation
Time frame: Intraoperatively , during induction of anaesthesia
Occurrence of esophageal intubation
Time frame: Intraoperatively , during induction of anaesthesia
Occurrence of airway trauma
Time frame: Intraoperatively , during induction of anaesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 12568178Brodsky JB. Positioning the morbidly obese patient for anesthesia. Obes Surg. 2002 Dec;12(6):751-8. doi: 10.1381/096089202320995510.
- Background: PubMed 13749923SELLICK BA. Cricoid pressure to control regurgitation of stomach contents during induction of anaesthesia. Lancet. 1961 Aug 19;2(7199):404-6. doi: 10.1016/s0140-6736(61)92485-0. No abstract available.
- Background: PubMed 8068068Vanner RG, Pryle BJ. Nasogastric tubes and cricoid pressure. Anaesthesia. 1993 Dec;48(12):1112-3. doi: 10.1111/j.1365-2044.1993.tb07560.x. No abstract available.
- Background: PubMed 11983669Smith KJ, Ladak S, Choi PT, Dobranowski J. The cricoid cartilage and the esophagus are not aligned in close to half of adult patients. Can J Anaesth. 2002 May;49(5):503-7. doi: 10.1007/BF03017931.
- Background: PubMed 19843793Rice MJ, Mancuso AA, Gibbs C, Morey TE, Gravenstein N, Deitte LA. Cricoid pressure results in compression of the postcricoid hypopharynx: the esophageal position is irrelevant. Anesth Analg. 2009 Nov;109(5):1546-52. doi: 10.1213/ane.0b013e3181b05404.
- Background: PubMed 89335Robinson JS, Thompson JM. Fatal aspiration (Mendelson's) syndrome despite antacids and cricoid pressure. Lancet. 1979 Aug 4;2(8136):228-30. doi: 10.1016/s0140-6736(79)90240-x.
- Background: PubMed 2791184Williamson R. Cricoid pressure. Can J Anaesth. 1989 Sep;36(5):601. doi: 10.1007/BF03005396. No abstract available.
- Background: PubMed 10209365Kluger MT, Short TG. Aspiration during anaesthesia: a review of 133 cases from the Australian Anaesthetic Incident Monitoring Study (AIMS). Anaesthesia. 1999 Jan;54(1):19-26. doi: 10.1046/j.1365-2044.1999.00642.x.
- Background: PubMed 7856895Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. Anesthesiology. 1995 Feb;82(2):367-76. doi: 10.1097/00000542-199502000-00007.
- Background: PubMed 9337361Thibodeau LG, Verdile VP, Bartfield JM. Incidence of aspiration after urgent intubation. Am J Emerg Med. 1997 Oct;15(6):562-5. doi: 10.1016/s0735-6757(97)90157-1.
- Background: PubMed 493710Tomkinson J, Turnbull A, Robson G, Cloake E, Adelstein AM, Weatherall J. Report on confidential enquiries into maternal deaths in England and Wales 1973-1975. Rep Health Soc Subj (Lond). 1979;14:1-166. No abstract available.
- Background: PubMed 22656679Guirro UB, Martins CR, Munechika M. Assessment of anesthesiologists' rapid sequence induction technique in an university hospital. Rev Bras Anestesiol. 2012 May-Jun;62(3):335-45. doi: 10.1016/S0034-7094(12)70134-4.
- Individual participant dataSharing planned: Undecided. Individual participant data that already summarized and analysed in the form of schematic diagram will be available to other researchers
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.
Shahmini Ganesh, MD principal investigator
UMMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison between two different intubating position in people with Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction, run by University of Malaya at 1 site in Malaysia.
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 6 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: status not confirmed, as of the sponsor's last update on 17 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahmini Ganesh, MD (0379492052, shahminig2805@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave (time frame: Intraoperatively , during induction of anaesthesia). 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 NCT03912935, which also lists 37 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 17 Apr 2019.