Intubation; Difficult or FailedNCT06405672
The Effect of Endotracheal Tube With Stylet in Morbidly Obese Patients
A study testing Endotracheal tube with stylet and Endotracheal tube alone in people with Intubation; Difficult or Failed and Obesity, Morbid, run by Antalya Training and Research Hospital.
Trial summary
The investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation; Difficult or Failed, Obesity, Morbid
- What is being tested?
- Endotracheal tube with stylet and Endotracheal tube alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 30 Sep 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index over 30 ASA physical status I-III Undergoing laparoscopic sleeve gastrectomy -
Who cannot join
- Body mass index under 30 ASA physical status IV Unable to cooperate Refused to give writtten informed consent-
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Using an Endotracheal Tube With Stylet Versus an Endotracheal Tube Alone in Morbidly Obese Patients
The investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.
Read the detailed description
Different intubation techniques have been used in morbidly obese patients undergoing general anesthesia. No study comparing the use of endotracheal tube with or without stylet was found in literature. Thus, the investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.
- Conditions
- Intubation; Difficult or Failed, Obesity, Morbid
- Being tested
- Endotracheal tube with stylet, Endotracheal tube alone
- Keywords
- different intubation techniques, endotracheal tube, obesity, stylet
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tube with styletProcedure or surgery
The obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy
Endotracheal tube aloneProcedure or surgery
The obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal tube with stylet | Other | The obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy Receives: Procedure: Endotracheal tube with stylet |
| Endotracheal tube alone | Other | The obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy Receives: Procedure: Endotracheal tube alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
from handling laryngoscope to first vision of end-tidal CO2 waveform
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
Intubation success
success or failure of first intubation attempt
Measured: through study completion, an average of 6 months
complications
Undesirable complications such as laryngospazm, hoarseness will be recorded at postoperative period
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kerem İnanoğlu, MD, Principal investigator, Antalya TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405672
- Sponsor's protocol ID
- 1/17
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaszynski T, Pietrzyk M, Szewczyk T, Gaszynska E. A comparison of performance of endotracheal intubation using the Levitan FPS optical stylet or Lary-Flex videolaryngoscope in morbidly obese patients. ScientificWorldJournal. 2014;2014:207591. doi: 10.1155/2014/207591. Epub 2014 May 20.
PubMed 24967423Nicholson A, Smith AF, Lewis SR, Cook TM. Tracheal intubation with a flexible intubation scope versus other intubation techniques for obese patients requiring general anaesthesia. Cochrane Database Syst Rev. 2014 Jan 17;2014(1):CD010320. doi: 10.1002/14651858.CD010320.pub2.
PubMed 24443105
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Using an Endotracheal Tube With Stylet Versus an Endotracheal Tube Alone in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT06405672
- Acronym / sponsor ID
- 1/17
- Conditions
- Intubation; Difficult or Failed, Obesity, Morbid
- Keywords
- different intubation techniques, endotracheal tube, obesity, stylet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 8 May 2024 (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.
The investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.
Detailed description
Different intubation techniques have been used in morbidly obese patients undergoing general anesthesia. No study comparing the use of endotracheal tube with or without stylet was found in literature. Thus, the investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal tube with stylet | Other | Procedure: Endotracheal tube with styletThe obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy |
| Endotracheal tube alone | Other | Procedure: Endotracheal tube aloneThe obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index over 30 ASA physical status I-III Undergoing laparoscopic sleeve gastrectomy -
Key exclusion criteria (1 listed)
- Body mass index under 30 ASA physical status IV Unable to cooperate Refused to give writtten informed consent-
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 |
|---|---|---|
| Endotracheal tube with styletThe obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy | Procedure or surgery | Endotracheal tube with stylet |
| Endotracheal tube aloneThe obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy | Procedure or surgery | Endotracheal tube alone |
Primary outcome
Intubation time
Time frame: through study completion, an average of 6 months
from handling laryngoscope to first vision of end-tidal CO2 waveform
2 secondary outcomes
Intubation success
Time frame: through study completion, an average of 6 months
complications
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 24967423Gaszynski T, Pietrzyk M, Szewczyk T, Gaszynska E. A comparison of performance of endotracheal intubation using the Levitan FPS optical stylet or Lary-Flex videolaryngoscope in morbidly obese patients. ScientificWorldJournal. 2014;2014:207591. doi: 10.1155/2014/207591. Epub 2014 May 20.
- Background: PubMed 24443105Nicholson A, Smith AF, Lewis SR, Cook TM. Tracheal intubation with a flexible intubation scope versus other intubation techniques for obese patients requiring general anaesthesia. Cochrane Database Syst Rev. 2014 Jan 17;2014(1):CD010320. doi: 10.1002/14651858.CD010320.pub2.
- Individual participant dataSharing planned: No
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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.
Kerem İnanoğlu, MD principal investigator
Antalya TRH
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal tube with stylet and Endotracheal tube alone in people with Intubation; Difficult or Failed and Obesity, Morbid, run by Antalya Training and Research Hospital.
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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerem İnanoğlu, MD (+902422494400, kinanoglu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation time (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06405672, which also lists 2 linked publications.
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 8 May 2024.