Trial Outcomes & Findings for Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery (NCT NCT02311153)
NCT ID: NCT02311153
Last Updated: 2018-06-01
Results Overview
Presence or absence of blood/secretions as noted in trachea and larynx. Patients were evaluated based on a soiling score completed by the surgeon, ranging from 0 (no contamination or soilage) to 3 (contamination of the tube/bloody secretions).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
intraoperative, within about 1 hour
Results posted on
2018-06-01
Participant Flow
Recruitment was completed in clinic and the pre-operative surgical area.
2 patients were consented and enrolled in the clinic setting, but they did not end up being randomized: 1 did not proceed with surgery 1 was diagnosed with sleep apnea, which is exclusionary
Participant milestones
| Measure |
Endotracheal Intubation
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
|
Laryngeal Mask Airway
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
49
|
|
Overall Study
COMPLETED
|
48
|
42
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Endotracheal Intubation
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
|
Laryngeal Mask Airway
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
Baseline Characteristics
Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery
Baseline characteristics by cohort
| Measure |
Endotracheal Intubation
n=53 Participants
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
|
Laryngeal Mask Airway
n=49 Participants
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
|
Total
n=102 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
|
35 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=99 Participants
|
49 participants
n=107 Participants
|
102 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: intraoperative, within about 1 hourPopulation: Participants that started the study were analyzed. Data was missing for 1 participant in each arm.
Presence or absence of blood/secretions as noted in trachea and larynx. Patients were evaluated based on a soiling score completed by the surgeon, ranging from 0 (no contamination or soilage) to 3 (contamination of the tube/bloody secretions).
Outcome measures
| Measure |
Endotracheal Intubation
n=52 Participants
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
|
Laryngeal Mask Airway
n=48 Participants
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
|
|---|---|---|
|
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score
Soilage score 0
|
12 Participants
|
10 Participants
|
|
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score
Soilage score 1
|
15 Participants
|
21 Participants
|
|
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score
Soilage score 2
|
15 Participants
|
10 Participants
|
|
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score
Soilage score 3
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: beginning and end of anesthesia (approximately 2 hours)Start and stop time of anesthesia as recorded in anesthesia record
Outcome measures
| Measure |
Endotracheal Intubation
n=53 Participants
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
|
Laryngeal Mask Airway
n=49 Participants
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
|
|---|---|---|
|
Anesthesia Time in Minutes
|
61 minutes
Interval 11.0 to 167.0
|
49 minutes
Interval 17.0 to 156.0
|
SECONDARY outcome
Timeframe: time spent in recovery room after surgery (approximately 4 hours)Population: Participants that started the study were analyzed.
Minutes spent in recovery room as recorded in the recovery room record
Outcome measures
| Measure |
Endotracheal Intubation
n=53 Participants
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
|
Laryngeal Mask Airway
n=49 Participants
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
|
|---|---|---|
|
Recovery Time in Minutes
PACU phase 1 time
|
34.5 minutes
Interval 7.0 to 111.0
|
30 minutes
Interval 5.0 to 112.0
|
|
Recovery Time in Minutes
PACU phase 2 time
|
37.5 minutes
Interval 2.0 to 181.0
|
40 minutes
Interval 0.0 to 220.0
|
SECONDARY outcome
Timeframe: From start of anesthesia through hospital discharge (approximately 6 hours)As recorded in anesthesia care record
Outcome measures
| Measure |
Endotracheal Intubation
n=53 Participants
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
|
Laryngeal Mask Airway
n=49 Participants
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
|
|---|---|---|
|
Presence of Laryngeal Spasm
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 hour medicine requirementPopulation: Participants that started the study were analyzed. Data was missing for 5 participants in the Endotracheal intubation arm and 7 participants in the Laryngeal mask airway arm.
Recording pain medications given to patient as noted in the recovery room records and medication administration record
Outcome measures
| Measure |
Endotracheal Intubation
n=48 Participants
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
|
Laryngeal Mask Airway
n=42 Participants
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
|
|---|---|---|
|
Post-op Pain Med Requirements
> 15 pills
|
0 Participants
|
0 Participants
|
|
Post-op Pain Med Requirements
10-14 pills
|
2 Participants
|
3 Participants
|
|
Post-op Pain Med Requirements
5-9 pills
|
3 Participants
|
8 Participants
|
|
Post-op Pain Med Requirements
1-4 pills
|
21 Participants
|
13 Participants
|
|
Post-op Pain Med Requirements
No pain meds taken
|
22 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Start of surgery through hospital discharge (approximately 6 hours)Population: Participants that started the study were analyzed.
Outcome measures
| Measure |
Endotracheal Intubation
n=53 Participants
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
|
Laryngeal Mask Airway
n=49 Participants
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
|
|---|---|---|
|
Presence or Absence of Airway Complications
Presence of airway complications
|
0 Participants
|
0 Participants
|
|
Presence or Absence of Airway Complications
Absence of airway complicaitons
|
53 Participants
|
49 Participants
|
Adverse Events
Endotracheal Intubation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laryngeal Mask Airway
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