Intubation; Difficult or FailedNCT06107751
Ramped and Sniffing Position for Cesarean Section Intubation.
A study testing Ramped position group and Sniffing position group in people with Intubation; Difficult or Failed, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Ramped position group and Sniffing position group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Oct 2023to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: Comparison of Ramped and Sniffing Positions in Video-laryngoscopy-guided Tracheal Intubation for Elective Cesarean Section: a Prospective Randomized Study.
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.
Read the 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.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Ramped position group, Sniffing position group
- Keywords
- Cesarean section, Intubation, Videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramped position groupOther
Also called Ramped position
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 groupOther
Also called Sniffing group
This position will be achieved by placing a 7 cm pillow under the occiput.
| Study group | Role | What they receive |
|---|---|---|
| Ramped position group | Active comparator | This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus Receives: Other: Ramped position group |
| Sniffing position group | Sham comparator | This position will be achieved by placing a 7 cm pillow under the occiput. Receives: Other: Sniffing position group |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Total intubation time
Total intubation time will be calculated by adding up the laryngoscopy time and tube insertion time.
Measured: 5 minutes after induction of general anesthesia
Secondary outcomes (5)
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 = ∞.
Measured: 5 minutes after induction of general anesthesia
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
Measured: 5 minutes after induction of general anesthesia
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.
Measured: 5 minutes after induction of general anesthesia
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.
Measured: 5 minutes after induction of general anesthesia
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.
Measured: postoperative 4th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start28 Oct 2023
- Primary completion30 Nov 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muhammet korkusuz, Karaman Training and Research Hospital
- Investigators
- Muhammet Korkusuz, MD, Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107751
- Sponsor's protocol ID
- 05-2023/14
- Status last verified
- Dec 2023
- First submitted
- 20 Oct 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ramped and Sniffing Positions in Video-laryngoscopy-guided Tracheal Intubation for Elective Cesarean Section: a Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT06107751
- Acronym / sponsor ID
- 05-2023/14
- Conditions
- Intubation; Difficult or Failed
- Keywords
- Cesarean section, Intubation, Videolaryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ramped position group | Active comparator | Other: Ramped position groupThis 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 | Sham comparator | Other: Sniffing position groupThis position will be achieved by placing a 7 cm pillow under the occiput. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramped position groupAlso: Ramped positionThis 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 |
| Sniffing position groupAlso: Sniffing groupThis position will be achieved by placing a 7 cm pillow under the occiput. | Other | Sniffing position group |
Primary outcome
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.
5 secondary outcomes
Incidence of difficult intubation
Time frame: 5 minutes after induction of general anesthesia
Incidence of difficult mask ventilation
Time frame: 5 minutes after induction of general anesthesia
Laryngoscopy time
Time frame: 5 minutes after induction of general anesthesia
Tube insertion time
Time frame: 5 minutes after induction of general anesthesia
Complications related to intubation
Time frame: postoperative 4th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammet Korkusuz, MD principal investigator
Karamanoğlu Mehmetbey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ramped position group and Sniffing position group in people with Intubation; Difficult or Failed, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Total intubation time (time frame: 5 minutes after induction of general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.