Ramped and Sniffing Position for Cesarean Section Intubation.

Sponsor
Karaman Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06107751
Collaborator
(none)
60
1
2
1.2
48.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ramped position group
  • Other: Sniffing position group
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant, Care Provider)
Masking Description:
Due to the nature of the study, patients and care providers will be blind
Primary Purpose:
Treatment
Official Title:
Comparison of Ramped and Sniffing Positions in Video-laryngoscopy-guided Tracheal Intubation for Elective Cesarean Section: a Prospective Randomized Study.
Actual Study Start Date :
Oct 28, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

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
Other Names:
  • Ramped position
  • Sham Comparator: Sniffing position group

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

    Other: Sniffing position group
    This position will be achieved by placing a 7 cm pillow under the occiput.
    Other Names:
  • Sniffing group
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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 = ∞.

    2. 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

    3. 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.

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karaman Training and Research Hospital Karaman Turkey 70200

    Sponsors and Collaborators

    • Karaman Training and Research Hospital

    Investigators

    • Principal Investigator: Muhammet Korkusuz, MD, Karamanoğlu Mehmetbey University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    muhammet korkusuz, Principal Investigator, MD, Karaman Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT06107751
    Other Study ID Numbers:
    • 05-2023/14
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 31, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by muhammet korkusuz, Principal Investigator, MD, Karaman Training and Research Hospital

    Study Results

    No Results Posted as of Oct 31, 2023