Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients

NCT07667010 | Not Yet Recruiting

• 1 other identifier: 1599
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstetric; Cesarean Birth; Airway Anesthesia; Intubation; General Anesthesia; Tracheal Intubation; Video Laryngoscopy; Obstetric Anesthesia; Obstetric Anesthesia Problems; General Anesthesia

Keywords

obstetric; obstetric anesthesia; intubation; airway safety in OB patients; video laryngoscopy; cesarean delivery; general anesthesia in cesarean delivery; macintosh blade; hyperangulated blade; intubation in OB patients; general anesthesia

Outcome Measures

Primary Outcomes (3)

• Patient Enrollment

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

  3 days

• 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

  3 days

• Data Completeness

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

  3 days

Study Arms (2)

Macintosh style blade

ACTIVE COMPARATOR

Study patients in this arm will be intubated using a Macintosh style blade

Device: Macintosh Style Blade

Hyperangulated blade

ACTIVE COMPARATOR

Study patients in this arm will be intubated using a Hyperangulated style blade

Device: Hyperangulated blade

Interventions

Macintosh Style Blade DEVICE

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

Macintosh style blade

Hyperangulated blade DEVICE

hyperangulated blade (with a more pronounced curve

Hyperangulated blade

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Pregnant patients undergoing emergency or urgent cesarean delivery under general anesthesia requiring tracheal intubation.

You may not qualify if:

• No tracheal intubation performed and (ii) patient refusal of consent.
• Patients not receiving general anesthesia.
• Patients that previously participated in the study.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Central Study Contacts

Fabricio B Zasso, MD

CONTACT

(416) 586-4800; fabricio.zasso@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The statistician, responsible for randomization, will remain blinded to outcome data during data collection and will perform the prespecified statistical analyses after database lock.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomization study, with a parallel interventional study model. Participants undergoing a Cesarean delivery (CD) under general anesthesia are assigned to intubation with either a Macintosh- or Hyperangulated-style blade. This assignment of participants is based on the 4-month time block at Mount Sinai Hospital's anesthesia department, which uses either the Macintosh- or Hyperangulated-style blade for airway intubation. Participants undergo general anesthesia (and airway intubation) based on the blade strategy that is in place during their procedure at Mount Sinai Hospital.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 24, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)