Ramped and Sniffing Position for Cesarean Section Intubation.

NCT06107751 | Completed

• 1 other identifier: 05-2023/14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will include pregnants who preferred to undergo general anesthesia for elective cesarean section. Ramped and sniffing positions of pregnant women during ventilation and intubation will be compared. The aim of this study is to investigate which position provides easier and faster intubation in pregnant women for cesarean section.

Conditions

Intubation; Difficult or Failed

Keywords

Cesarean section; Intubation; Videolaryngoscopy

Outcome Measures

Primary Outcomes (1)

• 1. Total intubation time

  Total intubation time will be calculated by adding up the laryngoscopy time and tube insertion time.

  5 minutes after induction of general anesthesia

Secondary Outcomes (5)

• Incidence of difficult intubation

  5 minutes after induction of general anesthesia

• Incidence of difficult mask ventilation

  5 minutes after induction of general anesthesia

• Laryngoscopy time

  5 minutes after induction of general anesthesia

• Tube insertion time

  5 minutes after induction of general anesthesia

• Complications related to intubation

  postoperative 4th hour

Study Arms (2)

Ramped position group

ACTIVE COMPARATOR

This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus

Other: Ramped position group

Sniffing position group

SHAM COMPARATOR

This position will be achieved by placing a 7 cm pillow under the occiput.

Other: Sniffing position group

Interventions

Ramped position group OTHER

This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus

Also known as: Ramped position

Ramped position group

Sniffing position group OTHER

This position will be achieved by placing a 7 cm pillow under the occiput.

Also known as: Sniffing group

Sniffing position group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Since intubation time for cesarean section will be evaluated, only female patients will be studied.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with American Society of Anesthesiologists physical status classification of II-III, who are planned for elective cesarean section, who are between the ages of 18 and 40, and who prefer general anesthesia will be included.

You may not qualify if:

• Patients who refuse to participate in the study, have orientation and cooperation disorders, have undergone head and neck surgery, have a history of difficult intubation, have a cervical spine defect, and have a risk of pulmonary aspiration will be excluded from the study.

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Study Officials

• Muhammet Korkusuz, MD

  Karamanoğlu Mehmetbey University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Due to the nature of the study, patients and care providers will be blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Model Details: There are two group; 1. Experimental Group: Group R; Ramped Group; Pillows will be placed under the patient's upper body and head, with the external auditory canal and sternal notch horizontal. 2. Sham Comparator: Group S; Sniffing Group; A 7 cm high pillow will be placed under the occiput while the patient is in the supine position.

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 30, 2023
• Study Start: October 28, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 5, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

TU (1)