Comparison of Laryngeal Mask Airway Supreme and Endotracheal Tube In Patients Undergoing Gynecological Laparoscopy Surgery

NCT02127632 | Completed Results

• 1 other identifier: 533-GOA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Endotracheal Tube (ETT) is still preferred for laparoscopic surgeries because of the fear of pulmonary aspiration and inadequate ventilation. Laryngeal mask Supreme (LM-S) is a single use device and the presence of a drain tube allows to separate the gastrointestinal and respiratory tracts. We planned to compare ventilation parameters and gastric distension scores of with LM-S vs ETT during laparoscopic gynecological surgery.

Conditions

Anaesthesia

Keywords

laryngeal mask Supreme; laparoscopic gynecologic surgery; Laryngeal mask during surgery

Outcome Measures

Primary Outcomes (1)

• Mean Airway Pressures

  The measure is the mean airway pressure (cmH2O): T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device

  At first and last 10 minutes of pneumoperitoneum

Secondary Outcomes (2)

• Evaluation of Gastric Distention

  Baseline

• Throat Pain According to Visual Analogue Scale

  postoperative 1st and 24th hours

Study Arms (2)

Group ETT (endo tracheal tube)

ACTIVE COMPARATOR

Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482

Device: Endotracheal Tube

Group LM-S(Laryngeal mask supreme Group)

EXPERIMENTAL

Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For \<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.

Device: Laryngeal Mask Airway-Supreme

Interventions

Endotracheal Tube DEVICE

ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482

Also known as: Device: Endotracheal Tube (ETT)

Group ETT (endo tracheal tube)

Laryngeal Mask Airway-Supreme DEVICE

Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson \& Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted. Other Names: LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7

Also known as: Group LM-S (laryngeal mask group).

Group LM-S(Laryngeal mask supreme Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA classification group I-II
• Between 18-65 years
• Undergoing elective laparoscopic gynecological surgery

You may not qualify if:

• Individuals with any neck and upper respiratory pathology
• Individuals at risk of gastric content regurgitation/aspiration (previous upper gastrointestinal surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)
• Individuals with low pulmonary compliance or high airway resistance (chronic lung diseases)
• Obese patients (BMI \>35)
• Individuals with sore throat, dysphagia and dysphonia
• Individuals with possibility or history of difficult airway
• Operation time planned for more than 4 hours

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Sule Ozbilgin

Izmi̇r, Narlıdere, 35320, Turkey (Türkiye)

Location

Related Publications (1)

• Kuvaki B, Ozbilgin S, Gunenc SF, Kucuk BA. Comparison of LM-Supreme and endotracheal tube in patients undergoing gynecological laparoscopic surgery. J Clin Monit Comput. 2020 Apr;34(2):295-301. doi: 10.1007/s10877-019-00310-2. Epub 2019 Apr 9.

  PMID: 30968326 DERIVED

Limitations and Caveats

We studied a female population with normal airways undergoing elective gynaecological laparoscopic surgery. Second, we only studied non-obese patients. Third we excluded cases with difficult airway.

Results Point of Contact

• Title: Anaesthesiology and Reanimation
• Organization: DorkuzEU

ozbilginsule@gmail.com

90.505.525.29.01

Study Officials

• BAHAR KUVAKİ, M.D.

  Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiology and Reanimation

Study Record Dates

• First Submitted: April 26, 2014
• First Posted: May 1, 2014
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 21, 2017
• Results First Posted: December 21, 2017

Record last verified: 2017-12

Locations

TU (1)