N/A
N=108
Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery
Anaesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02125838 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Asses to Ventilation Parameters — 451.8; 437.1; 457.2; 443.6 ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laryngeal Mask Airway-Supreme (Device); Endotracheal Tube (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dokuz Eylul University
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asses to Ventilation Parameters |
451.8; 437.1; 457.2; 443.6; 462; 451.3 | — |
| PRIMARY Asses to Peak Pressure |
13.1; 11.8; 19.5; 18.5; 18.7; 17.5 | — |
| PRIMARY Asses to Mean Pressure |
6.2; 5.9; 8.5; 8.1; 8.0; 7.5 | — |
| SECONDARY Quality of View According to Surgeon by Rate Scale |
0; 0; 4; 2; 20; 22 | — |
| SECONDARY Evaluation of Gastric Distention |
2.98; 3.144 | — |
| SECONDARY Ease of Orogastric Tube Placement Classification |
19; 38; 23; 10; 7; 2 | — |
| SECONDARY Haemodynamic Response to Insertion of Airway Device |
— | — |
| SECONDARY Incidence of Post-operative Sore Throat |
— | — |
Summary
Laryngeal mask (LM) use in gynecological laparoscopy, contrary to widespread opinion, does not increase the incidence of gastric aspiration, the failure of ventilation or the risk of pulmonary aspiration . LM is presented as an alternative to endo tracheal tube (ETT) in spontaneous or positive pressure ventilation (PPV) . LM has gained widespread popularity in England for gynecological laparoscopic procedures. In addition in many previous studies LM has been successfully shown to provide appropriate lung ventilation in laparoscopic surgical interventions .Miller et al. compared the use of ETT, LM-P laparoscopic gynecological interventions and identified advantages to LM use. The most important of these advantages was that, contrary to tracheal tube techniques for laparoscopic surgeries, use of supraglottic laryngeal devices or neuromuscular blocker agents (NBA) were not required during placement. Thus for laparoscopic surgeries, compared with the ETT technique, without the need for supraglottic laryngeal devices or muscular relaxants, it is easily placed and reduces the time spent in the operating room.
Our aim; to compare the use of LM-S and ETT without neuromuscular agents for laparoscopic gynecological intervention with positive pressure ventilation from a surgical viewpoint and in terms of effect on ventilation parameters.
Secondary aim, comparison of airway morbidity with endotracheal intubation and supraglottic.
Eligibility Criteria
Inclusion Criteria
- ASA classification group I-II
- Between 18-65 years
- Undergoing elective laparoscopic gynecological surgery
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02125838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.