Ramped and Sniffing Position for Cesarean Section Intubation.

Intubation; Difficult or Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06107751
• Other study ID #: 05-2023/14
• Status: Completed
• Phase: N/A
• Start date: October 28, 2023
• Est. completion date: December 5, 2023

Study information

• Verified date: December 2023
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 5, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

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

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 = 8.	5 minutes after induction of general anesthesia
Secondary	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
Secondary	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
Secondary	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
Secondary	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