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Completed

NCT Number: NCT06107751

Ramped and Sniffing Position for Cesarean Section Intubation.

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.

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Key information

Conditions

Intubation; Difficult or Failed

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ramped position group

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

Other names: Ramped position

Sniffing position group

Other

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

Other names: Sniffing group

Primary outcomes

  1. 1. Total intubation time

    Time frame: 5 minutes after induction of general anesthesia

    Total intubation time will be calculated by adding up the laryngoscopy time and tube insertion time.

Secondary outcomes

  1. Incidence of difficult intubation

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2023
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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