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Comparison of C-MAC D-blade video laryngoscope with C-MAC and Macintosh laryngoscope: A randomised, controlled trial in patients with normal airways

Clinical evaluation of C-MAC D-blade videolaryngoscope. Randomised comparison to C-MAC and direct laryngoscopy in patients with normal airways

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000154404
Enrollment
180
Registered
2016-02-09
Start date
2013-07-16
Completion date
2014-05-19
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The major goal of endotracheal intubation is to secure the airway during reanimation and anaesthesia. To ensure adequate laryngeal view during intubation we use devices called laryngoscopes. Many conditions in medical practice complicate that process and produce conditions known as difficult airway which can have severe consequences if intubation is not possible. Because of the problems that can arise from difficult airway, new technologies were developed and video laryngoscopy has a major role in it. The main objective of this research is to compare intubation characteristics of the C-MAC D-Blade video laryngoscope with C-MAC video laryngoscope and direct laryngoscopy. The hypothesis of our research is that more curved design of D-blade will assure better laryngeal view compared to other devices and consequently intubation would be less difficult and total time to successful intubation would be comparable.

Interventions

We recruited 180 patients of ASA physical status 1-3 who were scheduled for elective surgery under general anaesthesia requiring endotracheal intubation. After obtaining written informed consent, patients were assigned, by using a computer-generated randomisation code, to laryngoscopy with either C-MAC D-blade, C-MAC with Macintosh blade or Macintosh laryngoscope. All tracheal intubations were performed by anesthesiologists who had used all the devices more than 60 times in practice. Standard m

We recruited 180 patients of ASA physical status 1-3 who were scheduled for elective surgery under general anaesthesia requiring endotracheal intubation. After obtaining written informed consent, patients were assigned, by using a computer-generated randomisation code, to laryngoscopy with either C-MAC D-blade, C-MAC with Macintosh blade or Macintosh laryngoscope. All tracheal intubations were performed by anesthesiologists who had used all the devices more than 60 times in practice. Standard monitoring devices were attached before induction of anaesthesia (pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff). After the pre-oxygenation with 100% oxygen in order to achieve end-tidal oxygen >80%,anesthesia was induced with intravenous sufentanil 0.2-0.3 µg.kg-1 and propofol 2-3 mg.kg-1. Rocuronium 0.6-0.9 mg.kg-1 was administered for neuromuscular blockade after confirmation of successful manual bag-mask ventilation with patients placed in „sniffing“ head position. A size 7.0 mm tracheal tube was used to intubate the trachea in female patients, and a size 7.5 mm tube was used for all male patients. If more than one intubation attempt was required, the patient received bag-and mask ventilation between attempts and various manoeuvres were employed, including external laryngeal pressure, readjustment of the stylet and use of a bougie. Failure of the procedure was declared if intubation was not achieved within 120s, if more than three intubation attempts were required or if oxygen saturation dropped below 95%.. Intubation attempt was defined as commencing with placement of the device past the level of upper incisors (or upper lip if patient had no teeth) and similarly ending with removal of the device past the level of upper incisors(or upper lip if patient had no teeth). The failed attempt was subsequently managed at the discretion of the attending anaesthesiologist and the chosen technique was recorded. Correct placement of the tracheal tube was confirmed by capnography and bilateral chest auscultation. Data were collected by one independent observer.

Sponsors

University Clinical Hospital Sestre milosrdnice
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

patients with normal airway set for general anaesthesia with endotracheal intubation needed

Exclusion criteria

history of known difficult airway, non-fasting, ASA status IV and above, known airway pathology

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026