Trial Outcomes & Findings for Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery (NCT NCT02125838)
NCT ID: NCT02125838
Last Updated: 2017-03-28
Results Overview
tidal volume (ml) at certain time intervals 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
108 participants
Primary outcome timeframe
intraoperative period
Results posted on
2017-03-28
Participant Flow
Participant milestones
| Measure |
Group ETT
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT
|
Group LMS
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.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)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.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Group ETT
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT
|
Group LMS
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.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery
Baseline characteristics by cohort
| Measure |
Group ETT
n=54 Participants
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT
|
Group LMS
n=54 Participants
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.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)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.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
54 participants
n=99 Participants
|
54 participants
n=107 Participants
|
108 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: intraoperative periodtidal volume (ml) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device
Outcome measures
| Measure |
Group ETT
n=50 Participants
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT
|
Group LMS
n=50 Participants
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.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)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.
|
|---|---|---|
|
Asses to Ventilation Parameters
T1
|
451.8 ml
Standard Deviation 62.6
|
437.1 ml
Standard Deviation 62.0
|
|
Asses to Ventilation Parameters
T2
|
457.2 ml
Standard Deviation 57.1
|
443.6 ml
Standard Deviation 61.5
|
|
Asses to Ventilation Parameters
T3
|
462 ml
Standard Deviation 63.0
|
451.3 ml
Standard Deviation 58.5
|
|
Asses to Ventilation Parameters
T4
|
464.8 ml
Standard Deviation 58.7
|
448.1 ml
Standard Deviation 53.9
|
PRIMARY outcome
Timeframe: intraoperative periodpeak pressure (cmH20) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device
Outcome measures
| Measure |
Group ETT
n=50 Participants
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT
|
Group LMS
n=50 Participants
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.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)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.
|
|---|---|---|
|
Asses to Peak Pressure
T1
|
13.1 cmH20
Standard Deviation 3.5
|
11.8 cmH20
Standard Deviation 2.9
|
|
Asses to Peak Pressure
T2
|
19.5 cmH20
Standard Deviation 4.7
|
18.5 cmH20
Standard Deviation 4.5
|
|
Asses to Peak Pressure
T3
|
18.7 cmH20
Standard Deviation 5.6
|
17.5 cmH20
Standard Deviation 4.4
|
|
Asses to Peak Pressure
T4
|
14.8 cmH20
Standard Deviation 3.2
|
13.4 cmH20
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: during proceduremean pressures within the times below (cmH20) T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device
Outcome measures
| Measure |
Group ETT
n=50 Participants
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT
|
Group LMS
n=50 Participants
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.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)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.
|
|---|---|---|
|
Asses to Mean Pressure
T1
|
6.2 cmH20
Standard Deviation 1.7
|
5.9 cmH20
Standard Deviation 1.5
|
|
Asses to Mean Pressure
T2
|
8.5 cmH20
Standard Deviation 2.1
|
8.1 cmH20
Standard Deviation 3.1
|
|
Asses to Mean Pressure
T3
|
8.0 cmH20
Standard Deviation 1.8
|
7.5 cmH20
Standard Deviation 1.5
|
|
Asses to Mean Pressure
T4
|
6.6 cmH20
Standard Deviation 1.3
|
6.1 cmH20
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: intraoperative periodQuality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device by Rate Scale. Grade of quality of view were evaluated between 1-4 points (1-poor to 4-excellent)
Outcome measures
| Measure |
Group ETT
n=50 Participants
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT
|
Group LMS
n=50 Participants
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.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)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.
|
|---|---|---|
|
Quality of View According to Surgeon by Rate Scale
Grade IV
|
76 percentage of participants
|
76 percentage of participants
|
|
Quality of View According to Surgeon by Rate Scale
Grade I
|
0 percentage of participants
|
0 percentage of participants
|
|
Quality of View According to Surgeon by Rate Scale
Grade II
|
4 percentage of participants
|
2 percentage of participants
|
|
Quality of View According to Surgeon by Rate Scale
Grade III
|
20 percentage of participants
|
22 percentage of participants
|
SECONDARY outcome
Timeframe: BaselineTo 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
| Measure |
Group ETT
n=50 Participants
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT
|
Group LMS
n=50 Participants
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.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)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.
|
|---|---|---|
|
Evaluation of Gastric Distention
|
2.98 units on a scale
Standard Deviation 2.37
|
3.144 units on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: BaselinePopulation: Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.
Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.
Outcome measures
| Measure |
Group ETT
n=50 Participants
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT
|
Group LMS
n=50 Participants
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.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)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.
|
|---|---|---|
|
Ease of Orogastric Tube Placement Classification
diffucult
|
7 participants
|
2 participants
|
|
Ease of Orogastric Tube Placement Classification
very easy
|
19 participants
|
38 participants
|
|
Ease of Orogastric Tube Placement Classification
easy
|
23 participants
|
10 participants
|
|
Ease of Orogastric Tube Placement Classification
very diffucult
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineSystolic blood pressure and heart rate at two minutes after LM-S placement, before insufflation, 10 minutes after insufflation and trendelenburg position, before desufflation and before LM-S removal .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePatients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr and 24 hr after the end of surgery.
Outcome measures
Outcome data not reported
Adverse Events
Group ETT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group LMS
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place