The Effect of Endotracheal Tube With Stylet in Morbidly Obese Patients

Obesity, Morbid Clinical Trial

Official title:

Comparison of Using an Endotracheal Tube With Stylet Versus an Endotracheal Tube Alone in Morbidly Obese Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405672
• Other study ID #: 1/17
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Antalya Training and Research Hospital
• Contact: Kerem Inanoglu, MD
• Phone: +902422494400
• Email: kinanoglu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Body mass index over 30 ASA physical status I-III Undergoing laparoscopic sleeve gastrectomy -

Exclusion Criteria:

Body mass index under 30 ASA physical status IV Unable to cooperate Refused to give writtten informed consent-

Related Conditions & MeSH terms

• Intubation; Difficult or Failed
• Obesity, Morbid

Intervention

Procedure:
• Endotracheal tube with stylet
The obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy
• Endotracheal tube alone
The obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

References & Publications (2)

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. — View Citation

Nicholson 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;(1):CD010320. doi: 10.1002/14651858.CD010320.pub2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation time	from handling laryngoscope to first vision of end-tidal CO2 waveform	through study completion, an average of 6 months
Secondary	Intubation success	success or failure of first intubation attempt	through study completion, an average of 6 months
Secondary	complications	Undesirable complications such as laryngospazm, hoarseness will be recorded at postoperative period	through study completion, an average of 6 months