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An assessment of critical care intubations requiring an airway introducer with the two existing endotracheal tip designs : the INTUBATE study

INTUBATE: INTubation Using a Bougie with Alternative Tips Evaluation - An assessment of the perceived difficulty during critical care intubations requiring an airway introducer with the two existing endotracheal tip designs

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000363381
Acronym
INTUBATE
Enrollment
106
Registered
2026-03-24
Start date
2023-05-19
Completion date
2024-03-23
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We are conducting this research study because in sick people requiring help with breathing, the insertion of a breathing tube with the assistance of an airway introducer is frequently done. Often the breathing tube (endotracheal tube or ETT) will catch on the voicebox as it goes into the windpipe, requiring extra steps. There are two designs of endotracheal tube in common use, one has the tip with a side facing bevel, and the other with a front to back facing bevel. It is theorised that the direction of the bevel at the end of the endotracheal tube influences the ease of insertion, making it less likely to ‘catch’ when an airway introducer is routinely used. There are no studies that show this is the case with the current available combinations. This trial will address this lack of knowledge, and assist our departments to decide which design of tube to use. Currently we use both designs.

Interventions

To determine whether intubations using an Antero-Posterior (AP) bevel design with the Genesis or Parkerflex endotracheal tube compared to left-facing bevel of the Portex endotracheal tube results in significantly fewer observed difficulties in passing the ETT through the cords. critical care intubations are most frequently done using a airway introducer ("bougie") to intubate the trachea initially and then passing an endotracheal tube over the bougie into the airway. The design of the tip may i

To determine whether intubations using an Antero-Posterior (AP) bevel design with the Genesis or Parkerflex endotracheal tube compared to left-facing bevel of the Portex endotracheal tube results in significantly fewer observed difficulties in passing the ETT through the cords. critical care intubations are most frequently done using a airway introducer ("bougie") to intubate the trachea initially and then passing an endotracheal tube over the bougie into the airway. The design of the tip may influence the ease of passage and influence the time and the complications that are recognised. These intubations in critical care are done by emergency, intensive care and anaesthetic doctors in various stages of training. in a fully monitored hospital environment, supported by senior doctors and nurses. There are on average 5 critical care intubations in either ICU or Emergency departments per week. the trial is approved for a waiver of consent prior to randomisation, so there will be minimal or no delay before intubation, but later requires a consent to continue to collect data. The time taken for each intubation is typically 1-2 minutes for most intubations. The video-laryngosope used are either a C-MAC or a Glidescope with a blade of the clinicians choice and video recording, and will be mandated for all critical care intubations in our institution. A videolaryngoscope is a piece of equipment that has a small camera on the tip of a laryngoscope with a corresponding screen at the bedside to view the image. a laryngoscope is a handle with a curved "blade" that goes over the tongue to reach near the voicebox to allow a clear view of the voicebox (A.k.a. the larynx) so that a breathing tube or similar adjunct can be placed accurately. Fidelity or adherence to the protocol will be ensured by an Intubation Checklist which is performed involving all staff, and used for all critical care intubations and specifically updated for this study. If initial technique fails - the operators can use whatever device or adjunct or technique that will maximise their success - if the tube selection is changed it will be regarded as a response to one of the outcome questions of " did the tube size or type have to be changed". if the patient is intubated again on a separate occasion ( separate in time or place ) the patient may be included as a new event and randomised again - if there is appropriate time to randomise and the operators are agreeable to inclusion in the study. they would be excluded from randomisation if the operator decides beforehand that they require a different technique or opinion.

Sponsors

Sunshine Coast University Hospital Intensive Care Unit (SCUH ICU)
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients (> 17 years) requiring intubation in the Emergency Department or Intensive Care of The Sunshine Coast Health Service District.

Exclusion criteria

Patients where ‘emergent’ intubation is required will be excluded, as defined by: 1. cardiac or respiratory arrest where there is not time enough to complete the usual practice of performing the departmental Verbal Intubation Checklist and staff briefing. 2. Patients where a non-standard tube size or design is requested (for example sizes below 7 mm overall diameter (OD), and reinforced or RAE tubes).

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026