Trial Outcomes & Findings for I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery (NCT NCT02923427)

NCT ID: NCT02923427

Last Updated: 2020-10-27

Results Overview

This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 112 participants
• Primary outcome timeframe: At baseline and at 15, 30 and 60 minutes
• Results posted on: 2020-10-27

Participant Flow

Participant milestones

Measure	Laryngeal Mask Supreme Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Overall Study STARTED	55	57
Overall Study COMPLETED	51	55
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Laryngeal Mask Supreme Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Overall Study convert to laparatomy	2	2
Overall Study destaturation	1	0
Overall Study can not replace LMA	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Laryngeal Mask Supreme n=51 Participants Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel n=55 Participants Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications	Total n=106 Participants Total of all reporting groups
Age, Continuous	34.55 years STANDARD_DEVIATION 9.34 • n=51 Participants	36.44 years STANDARD_DEVIATION 8.31 • n=55 Participants	35.49 years STANDARD_DEVIATION 8.82 • n=106 Participants
Sex: Female, Male Female	51 Participants n=51 Participants	55 Participants n=55 Participants	106 Participants n=106 Participants
Sex: Female, Male Male	0 Participants n=51 Participants	0 Participants n=55 Participants	0 Participants n=106 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	51 Participants n=51 Participants	55 Participants n=55 Participants	106 Participants n=106 Participants

PRIMARY outcome

Timeframe: At baseline and at 15, 30 and 60 minutes

This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice.

Outcome measures

Measure	Laryngeal Mask Supreme n=51 Participants Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel n=55 Participants Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Airway Seal Pressure Values baseline	31.20 cm H2O Standard Deviation 8.07	27.58 cm H2O Standard Deviation 7.16
Airway Seal Pressure Values at 15 min	30.10 cm H2O Standard Deviation 6.48	28.76 cm H2O Standard Deviation 7.33
Airway Seal Pressure Values at 30 min	29.92 cm H2O Standard Deviation 6.19	28.71 cm H2O Standard Deviation 6.65
Airway Seal Pressure Values at 60 min	30.31 cm H2O Standard Deviation 6.19	29.13 cm H2O Standard Deviation 6.47

SECONDARY outcome

Timeframe: during pneumoperitoneum

quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst).

Outcome measures

Measure	Laryngeal Mask Supreme n=51 Participants Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel n=55 Participants Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Visual Quality	3.941 units on a scale Standard Deviation 0.42	3.945 units on a scale Standard Deviation 0.40

SECONDARY outcome

Timeframe: following airway device insertion up to 5 minutes

Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult.

Outcome measures

Measure	Laryngeal Mask Supreme n=51 Participants Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel n=55 Participants Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Gastric Tube Insertion very easy	33 participants	12 participants
Gastric Tube Insertion easy	18 participants	27 participants
Gastric Tube Insertion difficult	0 participants	10 participants
Gastric Tube Insertion very difficult	0 participants	6 participants

SECONDARY outcome

Timeframe: postoperative first hour and 24th hour

Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - "no pain" and "worst pain". Total range provided"0 (no pain) to 10 (worst pain).

Outcome measures

Measure	Laryngeal Mask Supreme n=51 Participants Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel n=55 Participants Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Postoperative Pharyngolaryngeal Morbidity at first hour	0.43 units on a scale Standard Deviation 1.02	0.16 units on a scale Standard Deviation 0.06
Postoperative Pharyngolaryngeal Morbidity 24th hour	0.02 units on a scale Standard Deviation 0.140	0.00 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: baseline

Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire.

Outcome measures

Measure	Laryngeal Mask Supreme n=51 Participants Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel n=55 Participants Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Sufficiency of Pneumoperitoneum sufficient	50 Participants	55 Participants
Sufficiency of Pneumoperitoneum insufficient	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline and at 15, 30 and 60 minutes

Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma.

Outcome measures

Measure	Laryngeal Mask Supreme n=51 Participants Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel n=55 Participants Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Mean Airway Pressure Values baseline	5.84 cm H2O Standard Deviation 0.92	5.82 cm H2O Standard Deviation 1.09
Mean Airway Pressure Values at 15 min	7.84 cm H2O Standard Deviation 1.23	7.87 cm H2O Standard Deviation 1.47
Mean Airway Pressure Values at 30 min	7.45 cm H2O Standard Deviation 1.31	7.27 cm H2O Standard Deviation 1.39
Mean Airway Pressure Values at 60 min	6.51 cm H2O Standard Deviation 1.15	6.29 cm H2O Standard Deviation 1.21

SECONDARY outcome

Timeframe: postoperative first hour and 24th hour

We evaluated while a patient was talking with us that the patient has dysphonia or not .

Outcome measures

Measure	Laryngeal Mask Supreme n=51 Participants Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel n=55 Participants Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Dysphonia With Yes/no. at first hour-no	51 Number of Participants without Dysphonia	55 Number of Participants without Dysphonia
Dysphonia With Yes/no. at 24th hour-no	51 Number of Participants without Dysphonia	55 Number of Participants without Dysphonia

SECONDARY outcome

Timeframe: postoperative first hour and 24th hour

We asked the question that you have a pain while you were swallowing, yes or not.

Outcome measures

Measure	Laryngeal Mask Supreme n=51 Participants Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications	I-gel n=55 Participants Insertion of the "i-gel" and evaluation of its clinical performance i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications
Disphagia at first hour-no	47 Participants	54 Participants
Disphagia at 24th hour-no	51 Participants	55 Participants

Adverse Events

Laryngeal Mask Supreme

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

I-gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anaesthesiology and Intensive Care, Sule Ozbilgin

DorkuzEU

Phone: 905055252901

Email: ozbilginsule@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place