Ramped and Sniffing Position for Cesarean Section Intubation.

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed
• Interventions: Other: Ramped position group; Other: Sniffing position group

• Registration Number: NCT06107751
• Lead Sponsor: Karaman Training and Research Hospital

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.

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 Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-25
• Study Start: 2023-10-28
• Study First Posted: 2023-10-30
• Primary Completion: 2023-11-30
• Status Verified: 2023-12
• Study Completion: 2023-12-05
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ramped position group	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
Sniffing position group	Sniffing position group	This position will be achieved by placing a 7 cm pillow under the occiput.

Primary Outcome Measures

Name	Time	Method
1. Total intubation time	5 minutes after induction of general anesthesia	Total intubation time will be calculated by adding up the laryngoscopy time and tube insertion time.

Secondary Outcome Measures

Name	Time	Method
Incidence of difficult intubation	5 minutes after induction of general anesthesia	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 = ∞.
Incidence of difficult mask ventilation	5 minutes after induction of general anesthesia	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
Laryngoscopy time	5 minutes after induction of general anesthesia	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.
Tube insertion time	5 minutes after induction of general anesthesia	The timing measurements will begin when the endotracheal tube first passes between the teeth and ended when the tube passes through the glottis.
Complications related to intubation	postoperative 4th hour	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.

Trial Locations

Locations (1)

Karaman Training and Research Hospital; 🇹🇷 Karaman, Turkey