Clinical trial NCT06107751: Ramped and Sniffing Position for Cesarean Section Intubation.
Official title: Comparison of Ramped and Sniffing Positions in Video-laryngoscopy-guided Tracheal Intubation for Elective Cesarean Section: a Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Keywords: Cesarean section
Intubation
Videolaryngoscopy
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 1. Total intubation time
timeFrame: 5 minutes after induction of general anesthesia
Secondary outcomes:
measure: Incidence of difficult intubation
timeFrame: 5 minutes after induction of general anesthesia
measure: Incidence of difficult mask ventilation
timeFrame: 5 minutes after induction of general anesthesia
measure: Laryngoscopy time
timeFrame: 5 minutes after induction of general anesthesia
measure: Tube insertion time
timeFrame: 5 minutes after induction of general anesthesia
measure: Complications related to intubation
timeFrame: postoperative 4th hour
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karamanoğlu Mehmetbey University
name: Muhammet Korkusuz, MD
role: PRINCIPAL_INVESTIGATOR
References: