Ramped and Sniffing Position for Cesarean Section Intubation.

Comparison of Ramped and Sniffing Positions in Video-laryngoscopy-guided Tracheal Intubation for Elective Cesarean Section: a Prospective Randomized Study.

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed
• Intervention / Treatment: Other: Ramped position group; Other: Sniffing position group

Detailed Description

Estimates of the frequency of difficult and failed intubation in the obstetric population vary within a wide range of percentiles. Several times higher than those reported for the general surgery population. Functional Residual Capacity decreases by 10% - 25% in Pregnant women. Pregnant women are more susceptible to hypoxia as a result of this decline, which also encourages intubation to occur more rapidly. Intubation success and shortening of intubation time have improved positively with videolaryngoscopes. On the other hand, the position of the patient during intubation contributes to the speed and success of intubation. It has been shown that intubation is faster and first-pass success is higher in the ramped position in morbidly obese patients.This study will compare the effectiveness of ramp and sniffing positions on intubation time and success in obese patients and pregnant women with similar physical changes.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ramped position group; 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; 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 Names: Ramped position
Sham Comparator: Sniffing position group; This position will be achieved by placing a 7 cm pillow under the occiput.	Other: Sniffing position group; This position will be achieved by placing a 7 cm pillow under the occiput.; Other Names: Sniffing group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of difficult intubation	The Intubation Difficulty Scale (IDS) will be used to define the intubation difficulty. Intubation is considered easy if IDS=0, slight difficulty if 0 < IDS < 5, Moderate to Major Difficulty if 5 < IDS, impossible if IDS = ∞.	5 minutes after induction of general anesthesia
Incidence of difficult mask ventilation	The Warters Scale will be used to define the mask ventilation difficulty. Difficult mask ventilation is defined as a score ≥ 4 on the Warters scale	5 minutes after induction of general anesthesia
Laryngoscopy time	The timing measurements will begin when the videolaryngoscope blade first passes between the teeth and will end when the best glottic view is obtained on the videolaryngoscopy monitor.	5 minutes after induction of general anesthesia
Tube insertion time	The timing measurements will begin when the endotracheal tube first passes between the teeth and ended when the tube passes through the glottis.	5 minutes after induction of general anesthesia
Complications related to intubation	A postoperative follow-up assessment will be performed approximately 4 hr after surgery by a co-investigator blinded to the intubation position to evaluate the presence and severity of sore throat, any changes in voice, trauma to the lip, tongue, palate, or teeth.	postoperative 4th hour

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Muhammet Korkusuz, MD, Karamanoğlu Mehmetbey University

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cesarean section; Videolaryngoscopy; Intubation
• Other Study ID Numbers: 05-2023/14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No