Ramped and Sniffing Position for Cesarean Section Intubation.

Study Overview
=================
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.

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

Conditions
-----------------
Intubation; Difficult or Failed

Intervention / Treatment
-----------------
* Other: Ramped position group
* Other: Sniffing position group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two group; 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. 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ramped position group<br>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<br>* This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus<br>* Other names: Ramped position;|
| Sham Comparator: Sniffing position group<br>This position will be achieved by placing a 7 cm pillow under the occiput. | Other: Sniffing position group<br>* This position will be achieved by placing a 7 cm pillow under the occiput.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean section, Intubation, Videolaryngoscopy