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Ramped and Sniffing Position for Cesarean Section Intubation.

NCT ID: NCT06107751

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-28

Study Completion Date

2023-12-05

Brief Summary

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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

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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.

Conditions

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Intubation; Difficult or Failed

Keywords

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Cesarean section Intubation Videolaryngoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Due to the nature of the study, patients and care providers will be blind

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ramped position group

Intervention Type OTHER

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.

Group Type SHAM_COMPARATOR

Sniffing position group

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Sniffing position group

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

Intervention Type OTHER

Other Intervention Names

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Ramped position Sniffing group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karaman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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muhammet korkusuz

Principal Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammet Korkusuz, MD

Role: PRINCIPAL_INVESTIGATOR

Karamanoğlu Mehmetbey University

Locations

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Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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05-2023/14

Identifier Type: -

Identifier Source: org_study_id