Trial Outcomes & Findings for Comparison of Laryngeal Mask Airway Supreme and Endotracheal Tube In Patients Undergoing Gynecological Laparoscopy Surgery (NCT NCT02127632)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

At first and last 10 minutes of pneumoperitoneum

Results posted on

2017-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Group ETT (Endo Tracheal Tube) 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 Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel 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	Group LM-S(Laryngeal Mask Supreme Group) 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. Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group ETT (Endo Tracheal Tube) n=50 Participants 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 Laryngeal Mask Airway-Supreme: 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	Group LM-S(Laryngeal Mask Supreme Group) n=50 Participants 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. Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482	Total n=100 Participants Total of all reporting groups
Age, Continuous	39.36 years STANDARD_DEVIATION 11.52 • n=5 Participants	38.86 years STANDARD_DEVIATION 11.48 • n=7 Participants	39.11 years STANDARD_DEVIATION 11.45 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Turkey	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: At first and last 10 minutes of pneumoperitoneum

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

Outcome measures

Outcome measures
Measure	Group ETT (Endo Tracheal Tube) n=50 Participants 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 Laryngeal Mask Airway-Supreme: 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	Group LM-S(Laryngeal Mask Supreme Group) n=50 Participants 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. Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Mean Airway Pressures T1	7 cmH20 Interval 5.0 to 9.0	6 cmH20 Interval 4.0 to 9.0
Mean Airway Pressures T2	8 cmH20 Interval 6.0 to 12.0	8 cmH20 Interval 6.0 to 19.0
Mean Airway Pressures T3	8 cmH20 Interval 6.0 to 12.0	8 cmH20 Interval 4.0 to 17.0
Mean Airway Pressures T4	7 cmH20 Interval 5.0 to 11.0	7 cmH20 Interval 5.0 to 12.0

SECONDARY outcome

Timeframe: Baseline

To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)

Outcome measures

Outcome measures
Measure	Group ETT (Endo Tracheal Tube) n=50 Participants 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 Laryngeal Mask Airway-Supreme: 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	Group LM-S(Laryngeal Mask Supreme Group) n=50 Participants 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. Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Evaluation of Gastric Distention	3.24 units on a scale Standard Deviation 1.99	2.02 units on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: postoperative 1st and 24th hours

Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, 1 hr and 24 hr after the end of surgery according to Visual Analogue Scale. (range min. 0, max.10; \>4 analgesia planned)

Outcome measures

Outcome measures
Measure	Group ETT (Endo Tracheal Tube) n=50 Participants 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 Laryngeal Mask Airway-Supreme: 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	Group LM-S(Laryngeal Mask Supreme Group) n=50 Participants 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. Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Throat Pain According to Visual Analogue Scale postoperative 1st hour	2.04 point Standard Deviation 1.61	0.32 point Standard Deviation 0.76
Throat Pain According to Visual Analogue Scale postoperative 24th hours	0 point Standard Deviation 0	0 point Standard Deviation 0

Adverse Events

Group ETT (Endo Tracheal Tube)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group LM-S(Laryngeal Mask Supreme Group)

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 Reanimation

DorkuzEU

Phone: 90.505.525.29.01

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place