Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

About this trial

Cesarean section under general anesthesia requires intubation (insertion of a tube through the mouth into the breathing pipe to support breathing during the surgery). A device called a video laryngoscope is used, which has a smooth, curved, or less curved component called 'a blade' that helps the doctor gently see the voice box and guide the breathing tube safely into place during anesthesia; it is not a sharp tool blade.

There are two types of video laryngoscopes blades: a Macintosh- style blade with a gentle curve, approximately 90 degrees) and a hyperangulated blade (with a more pronounced curve).

Although video laryngoscopes are safe and both types have been used for around 20 years, it is not known whether one type works better that the other in patients undergoing cesarean delivery under general anesthesia. Because general anesthesia is used in only a small proportion (about 5%) of all cesarean deliveries, research in this area is limited.

The main purpose of the study is to assess if a study comparing these two types of blades in the obstetric population is feasible. This is also known as a feasibility study, which aims to test the study plan and determine whether enough participants will join a larger study and accept the study procedures. The results will be used as a guide for a larger study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

No tracheal intubation performed and (ii) patient refusal of consent.

Patients not receiving general anesthesia.

Patients that previously participated in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Macintosh Style Blade

    Device

    Macintosh- style blade with a gentle curve, approximately 90 degrees

  • Hyperangulated blade

    Device

    hyperangulated blade (with a more pronounced curve

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Macintosh style bladeActive comparator 1 intervention
Group B: Hyperangulated bladeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient Enrollment

Percentage of eligible cesarean deliveries under general anesthesia in which patients are recruited and consented

Time frame
3 days
2

Intervention Adherence

Percentage of cases in which the assigned time-block blade was used for the first intubation attempt, with documentation of crossovers and reasons

Time frame
3 days
3

Data Completeness

Percentage of patients with complete data on key airway and perioperative outcomes including postoperatively 3-day follow-up data.

Time frame
3 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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