Anesthesia Intubation ComplicationPhase 4NCT01150838

Propofol for Pediatric Tracheal Intubation With Deep Anesthesia During Sevoflurane Induction

A Phase 4 study testing propofol in people with Anesthesia Intubation Complication, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the amount of propofol required to achieve 50% of patients obtaining a perfect ("excellent") intubation score of 5 on the Steyn modification of the Helbo-Hansen Intubation Score, when placing a tracheal tube in children 1-6 years and 6-12 years (division of age groups at 6th… Read more about this study

Who is it for?: Ages 1 year to 11 years
Conditions the study is for: Anesthesia Intubation Complication
What is being tested?: propofol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Jun 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 year to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Informed consent / assent
Ages 1-11 years (12 - 132 months)
American Society of Anesthesiology (ASA) physical status 1 or 2, which implies that the patient has no comorbidity that limits daily function.
Scheduled for non-emergent surgery/ procedure under general anesthesia in which the anesthesia team intends to place an endotracheal tube
Expected routine intubation according to physical exam and history
Weight under 50 kg

Who cannot join

Requires neuromuscular blocking agents
Emergent surgery / procedure
Expected difficult intubation
ASA physical status 3 or 4
Weight over 50 kg
Age under 12 months or over 132 months
Allergy to study drugs to be used

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia Health System
Charlottesville, Virginia, 22911

Other trials in United States

About this study

Official title: Propofol for Pediatric Tracheal Intubation With Deep Anesthesia During Sevoflurane Induction: Dosing According to Elapsed Time for Two Age Groups,IRB-HSR# 13666

Read the detailed description

The practice of tracheal intubation of children without neuromuscular blockade (TIWNB) is widespread in pediatric anesthesia practices. There are several different methods reported for TIWNB, most of which involve administration of an inhaled anesthetic in combination with an intravenous adjunctive medication. The technique of administering propofol IV, immediately after IV placement, after a sevoflurane induction is perhaps the most popular method for pediatric TIWNB in the United States and worldwide (personal communication, and personal practice of this technique). At the time this study was proposed, nobody had studied this technique, and therefore nobody had quantified the amount of propofol needed in this context, or considered that the amount may differ according to the time sevoflurane has been administered at the moment propofol is given. This study divides patients into two age categories, with the first age group starting at the 1 year birthday and going up to the 6th year birthday, and the second age group going from the 6th year birthday up to the 12th birthday. The study also divides participants according to time that they have received sevoflurane from the start of anesthetic induction until intravenous access is achieved and propofol immediately administered. That amount of time varies in clinical practice due to variable difficulty obtaining pediatric intravenous access, and the amount of propofol may vary according to the amount of sevoflurane administered (time administered) because depth of anesthesia will increase with increasing duration of sevoflurane administration. The purpose of this study is to determine for both age groups the amount of propofol required to achieve 50% of patients obtaining a perfect intubation score of 5 on the Steyn modification of the Helbo-Hansen Intubation Score (HH Score), when placing a tracheal tube after various time periods of administration of sevoflurane. The 3 different time windows for sevoflurane administration prior to the propofol bolus will be 2-4 minutes, 4-6 minutes, and 6-8 minutes, starting the time clock at the start of anesthetic induction and ending at the moment the propofol is given. The study therefore has 6 separate groups (2 age groups x 3 time period groups) each of which utilizes a Dixon's Up and Down Method, moving up or down on the amount of propofol administered according to the result of the previous patient in each group (HH Score of 5 labeled "excellent intubation" indicates allocation of predetermined (0.3 mg/kg) incrementally smaller amount of propofol and >5 labeled as "not-excellent intubation" an increase of 0.3 mg/kg of propofol. Linear regression will be used for each of the 6 groups to determine the amount of propofol required to achieve 50% perfect intubation, with 95% confidence intervals also calculated.

Conditions: Anesthesia Intubation Complication
Being tested: propofol
Keywords: intubation of children without neuromuscular blockade

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

propofolDrug
Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range

Study groups in NCT01150838
Study group	Role	What they receive
Propofol administration	Experimental	For each of the 6 groups, propofol 2 mg/kg will be administered to first subject. The propofol dose will move separately for each of the 6 groups, and be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent" and decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until there are 6 "crossovers" as described above. Receives: Drug: propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

Estimated Propofol Doses Producing 50% Excellent Intubation Conditions
Logistic regression utilized to measure the amount of propofol to obtain 50% excellent intubation conditions for each age/time group.
The quality of tracheal intubation will be graded according to the Steyn modification of the Helbo-Hansen scoring system for tracheal intubation, which includes evaluation of ease of laryngoscopy, position of the vocal cords, coughing, jaw relaxation and movement of limbs, each evaluated on a 1-4 scale, with 1 being the best possible condition and 4 the worst. The intubation conditions will be classified as either excellent or not-excellent. "Excellent" will be defined as a total score of 5, a score of 1 for each category, and "not-excellent" will be a total score of 6-20, meaning a score of >1 in any category. While the outcome measure of each intubation is "excellent" or "not excellent", the overall outcome being generated is the amount of propofol in mg/kg required for 50% excellent intubation score.
Measured: Amount of time it takes to intubate each patient; approximate time is 15-45 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Jun 2010

First posted28 Jun 2010 (estimated)
Study startJul 2008
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
More trials run by University of VirginiaThe 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 4
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single study with 6 parallel groups as noted in the description. With Dixon's Up and Down Method for determining a 50th percentile of a dichotomous outcome, the number of patients required is not known prior to starting a study. Data from Paul and Fisher demonstrated that 6 "crossovers" (change in the dichotomous outcome from one patient to another, indicating change from increasing the dose of the study drug to decreasing it, or visa-versa). When choosing a meaningful starting point near the 50th percentile, the number required is typically 15-20 patients. With 6 study groups, the estimated number of patients required would be 90-120. Please Note: This is not a study where one can perform a power analysis and determine a required N.
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01150838
Sponsor's protocol ID: 13666
Status last verified: Jan 2021
First submitted: 2 Jun 2010
Last updated: 8 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Politis GD, Tobin JR, Morell RC, James RL, Cantwell MF. Tracheal intubation of healthy pediatric patients without muscle relaxant: a survey of technique utilization and perceptions of safety. Anesth Analg. 1999 Apr;88(4):737-41. doi: 10.1097/00000539-199904000-00009.
PubMed 10195514
Politis GD, Frankland MJ, James RL, ReVille JF, Rieker MP, Petree BC. Factors associated with successful tracheal intubation of children with sevoflurane and no muscle relaxant. Anesth Analg. 2002 Sep;95(3):615-20, table of contents. doi: 10.1097/00000539-200209000-00022.
PubMed 12198047
Simon L, Boucebci KJ, Orliaguet G, Aubineau JV, Devys JM, Dubousset AM. A survey of practice of tracheal intubation without muscle relaxant in paediatric patients. Paediatr Anaesth. 2002 Jan;12(1):36-42. doi: 10.1046/j.1460-9592.2002.00727.x.
PubMed 11849573
Blair JM, Hill DA, Bali IM, Fee JP. Tracheal intubating conditions after induction with sevoflurane 8% in children. A comparison with two intravenous techniques. Anaesthesia. 2000 Aug;55(8):774-8. doi: 10.1046/j.1365-2044.2000.01470.x.
PubMed 10947692
Dixon WJ. Quantal response to variable experimentation: the up-and-down method. In: McArthur JW, Colton T, eds. Statistics in Endocrionolgy. Cambridge: MIT Press, 1967: 251-264.
Viby-Mogensen J, Engbaek J, Eriksson LI, Gramstad L, Jensen E, Jensen FS, Koscielniak-Nielsen Z, Skovgaard LT, Ostergaard D. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand. 1996 Jan;40(1):59-74. doi: 10.1111/j.1399-6576.1996.tb04389.x.
PubMed 8904261
Steyn MP, Quinn AM, Gillespie JA, Miller DC, Best CJ, Morton NS. Tracheal intubation without neuromuscular block in children. Br J Anaesth. 1994 Apr;72(4):403-6. doi: 10.1093/bja/72.4.403.
PubMed 8155439
Paul M, Fisher DM. Are estimates of MAC reliable? Anesthesiology. 2001 Dec;95(6):1362-70. doi: 10.1097/00000542-200112000-00014.
PubMed 11748393
Hansen D, Schaffartzik W, Dopjans D, Heitz E, Striebel HW. Halothane-propofol anaesthesia for tracheal intubation in young children. Br J Anaesth. 1997 Apr;78(4):366-9. doi: 10.1093/bja/78.4.366.
PubMed 9135352
Min SK, Kwak YL, Park SY, Kim JS, Kim JY. The optimal dose of remifentanil for intubation during sevoflurane induction without neuromuscular blockade in children. Anaesthesia. 2007 May;62(5):446-50. doi: 10.1111/j.1365-2044.2007.05037.x.
PubMed 17448054
Nishina K, Mikawa K, Shiga M, Maekawa N, Obara H. Oral clonidine premedication reduces minimum alveolar concentration of sevoflurane for tracheal intubation in children. Anesthesiology. 1997 Dec;87(6):1324-7. doi: 10.1097/00000542-199712000-00010.
PubMed 9416716
Inomata S, Nishikawa T. Determination of end-tidal sevoflurane concentration for tracheal intubation in children with the rapid method. Can J Anaesth. 1996 Aug;43(8):806-11. doi: 10.1007/BF03013033.
PubMed 8840060
Inomata S, Yamashita S, Toyooka H, Yaguchi Y, Taguchi M, Sato S. Anaesthetic induction time for tracheal intubation using sevoflurane or halothane in children. Anaesthesia. 1998 May;53(5):440-5. doi: 10.1046/j.1365-2044.1998.00338.x.
PubMed 9659016
Mencke T, Echternach M, Kleinschmidt S, Lux P, Barth V, Plinkert PK, Fuchs-Buder T. Laryngeal morbidity and quality of tracheal intubation: a randomized controlled trial. Anesthesiology. 2003 May;98(5):1049-56. doi: 10.1097/00000542-200305000-00005.
PubMed 12717124
Vakkuri A, Yli-Hankala A, Sarkela M, Lindgren L, Mennander S, Korttila K, Saarnivaara L, Jantti V. Sevoflurane mask induction of anaesthesia is associated with epileptiform EEG in children. Acta Anaesthesiol Scand. 2001 Aug;45(7):805-11. doi: 10.1034/j.1399-6576.2001.045007805.x.
PubMed 11472278

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anesthesia Intubation Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Propofol for Pediatric Tracheal Intubation With Deep Anesthesia During Sevoflurane Induction: Dosing According to Elapsed Time for Two Age Groups,IRB-HSR# 13666
ClinicalTrials.gov ID: NCT01150838
Acronym / sponsor ID: 13666
Conditions: Anesthesia Intubation Complication
Keywords: intubation of children without neuromuscular blockade
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Study start: Jul 2008
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 28 Jun 2010 (estimated)
Results: Posted 8 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single study with 6 parallel groups as noted in the description. With Dixon's Up and Down Method for determining a 50th percentile of a dichotomous outcome, the number of patients required is not known prior to starting a study. Data from Paul and Fisher demonstrated that 6 "crossovers" (change in the dichotomous outcome from one patient to another, indicating change from increasing the dose of the study drug to decreasing it, or visa-versa). When choosing a meaningful starting point near the 50th percentile, the number required is typically 15-20 patients. With 6 study groups, the estimated number of patients required would be 90-120. Please Note: This is not a study where one can perform a power analysis and determine a required N.

Arm	Type	Receives
Propofol administration	Experimental	Drug: propofolFor each of the 6 groups, propofol 2 mg/kg will be administered to first subject. The propofol dose will move separately for each of the 6 groups, and be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent" and decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until there are 6 "crossovers" as described above.

Who may qualify

Ages: 1 year to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Informed consent / assent
Ages 1-11 years (12 - 132 months)
American Society of Anesthesiology (ASA) physical status 1 or 2, which implies that the patient has no comorbidity that limits daily function.
Scheduled for non-emergent surgery/ procedure under general anesthesia in which the anesthesia team intends to place an endotracheal tube
Expected routine intubation according to physical exam and history

Key exclusion criteria (7 listed)

Requires neuromuscular blocking agents
Emergent surgery / procedure
Expected difficult intubation
ASA physical status 3 or 4
Weight over 50 kg

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
propofolInitial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range	Drug	Propofol administration

Primary outcome

Estimated Propofol Doses Producing 50% Excellent Intubation Conditions
Time frame: Amount of time it takes to intubate each patient; approximate time is 15-45 seconds
Logistic regression utilized to measure the amount of propofol to obtain 50% excellent intubation conditions for each age/time group. The quality of tracheal intubation will be graded according to the Steyn modification of the Helbo-Hansen scoring system for tracheal intubation, which includes evaluation of ease of laryngoscopy, position of the vocal cords, coughing, jaw relaxation and movement of limbs, each evaluated on a 1-4 scale, with 1 being the best possible condition and 4 the worst. The intubation conditions will be classified as either excellent or not-excellent. "Excellent" will be defined as a total score of 5, a score of 1 for each category, and "not-excellent" will be a total score of 6-20, meaning a score of >1 in any category. While the outcome measure of each intubation is "excellent" or "not excellent", the overall outcome being generated is the amount of propofol in mg/kg required for 50% excellent intubation score.

Results and safety

Results posted to the registry on 8 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Age 1-6 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration	19	19
Age 1-6 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration	26	26
Age 1-6 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration	24	24
Age 6-11 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration	15	15
Age 6-11 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration	16	16
Age 6-11 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration	2	2

Primary outcome: Estimated Propofol Doses Producing 50% Excellent Intubation Conditions

Time frame: Amount of time it takes to intubate each patient; approximate time is 15-45 seconds. Mean (95% Confidence Interval). Unit: mg/kg

Measure	Age 1-6 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration n = 19	Age 1-6 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration n = 26	Age 1-6 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration n = 24	Age 6-11 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration n = 15	Age 6-11 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration n = 16
Value	1.48 (0.8 to 2.03)	0.00 (0.00 to 0.38)	0.07 (0.00 to 0.68)	2.35 (1.97 to 2.45)	2.33 (1.59 to 2.45)

Population analysed: Two patients in Age 6-11 years, 6-8 minutes, did not appear in baseline analysis population due to inadequate numbers collected in that age group and time range to be able to analyze; IV access always achieved earlier that 6 minutes due to ease of IV access.

Adverse events

Time frame: Adverse events data was collected only on day 0, starting at the time of anesthetic induction through the remaining time in the operating room, and through the recovery period, until time of discharge from the post-anesthetic care unit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propofol Administration	0 of 106 (0%)	0 of 106 (0%)	0 of 106

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10195514Politis GD, Tobin JR, Morell RC, James RL, Cantwell MF. Tracheal intubation of healthy pediatric patients without muscle relaxant: a survey of technique utilization and perceptions of safety. Anesth Analg. 1999 Apr;88(4):737-41. doi: 10.1097/00000539-199904000-00009.
Background: PubMed 12198047Politis GD, Frankland MJ, James RL, ReVille JF, Rieker MP, Petree BC. Factors associated with successful tracheal intubation of children with sevoflurane and no muscle relaxant. Anesth Analg. 2002 Sep;95(3):615-20, table of contents. doi: 10.1097/00000539-200209000-00022.
Background: PubMed 11849573Simon L, Boucebci KJ, Orliaguet G, Aubineau JV, Devys JM, Dubousset AM. A survey of practice of tracheal intubation without muscle relaxant in paediatric patients. Paediatr Anaesth. 2002 Jan;12(1):36-42. doi: 10.1046/j.1460-9592.2002.00727.x.
Background: PubMed 10947692Blair JM, Hill DA, Bali IM, Fee JP. Tracheal intubating conditions after induction with sevoflurane 8% in children. A comparison with two intravenous techniques. Anaesthesia. 2000 Aug;55(8):774-8. doi: 10.1046/j.1365-2044.2000.01470.x.
BackgroundDixon WJ. Quantal response to variable experimentation: the up-and-down method. In: McArthur JW, Colton T, eds. Statistics in Endocrionolgy. Cambridge: MIT Press, 1967: 251-264.
Background: PubMed 8904261Viby-Mogensen J, Engbaek J, Eriksson LI, Gramstad L, Jensen E, Jensen FS, Koscielniak-Nielsen Z, Skovgaard LT, Ostergaard D. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand. 1996 Jan;40(1):59-74. doi: 10.1111/j.1399-6576.1996.tb04389.x.
Background: PubMed 8155439Steyn MP, Quinn AM, Gillespie JA, Miller DC, Best CJ, Morton NS. Tracheal intubation without neuromuscular block in children. Br J Anaesth. 1994 Apr;72(4):403-6. doi: 10.1093/bja/72.4.403.
Background: PubMed 11748393Paul M, Fisher DM. Are estimates of MAC reliable? Anesthesiology. 2001 Dec;95(6):1362-70. doi: 10.1097/00000542-200112000-00014.
Background: PubMed 9135352Hansen D, Schaffartzik W, Dopjans D, Heitz E, Striebel HW. Halothane-propofol anaesthesia for tracheal intubation in young children. Br J Anaesth. 1997 Apr;78(4):366-9. doi: 10.1093/bja/78.4.366.
Background: PubMed 17448054Min SK, Kwak YL, Park SY, Kim JS, Kim JY. The optimal dose of remifentanil for intubation during sevoflurane induction without neuromuscular blockade in children. Anaesthesia. 2007 May;62(5):446-50. doi: 10.1111/j.1365-2044.2007.05037.x.
Background: PubMed 9416716Nishina K, Mikawa K, Shiga M, Maekawa N, Obara H. Oral clonidine premedication reduces minimum alveolar concentration of sevoflurane for tracheal intubation in children. Anesthesiology. 1997 Dec;87(6):1324-7. doi: 10.1097/00000542-199712000-00010.
Background: PubMed 8840060Inomata S, Nishikawa T. Determination of end-tidal sevoflurane concentration for tracheal intubation in children with the rapid method. Can J Anaesth. 1996 Aug;43(8):806-11. doi: 10.1007/BF03013033.
Individual participant dataSharing planned: No

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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.

George D Politis, MD principal investigator

UVA Department of Anesthesiology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing propofol in people with Anesthesia Intubation Complication, run by University of Virginia at 1 site in United States.

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 6 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 8 Feb 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 United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Estimated Propofol Doses Producing 50% Excellent Intubation Conditions (time frame: Amount of time it takes to intubate each patient; approximate time is 15-45 seconds). 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 NCT01150838, which also lists 15 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 8 Feb 2021.