Trial Outcomes & Findings for The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children (NCT NCT02645019)

Results Overview

Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

At time of EGD probe insertion

Results posted on

2023-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Cuffed ETT Airway secured using a cuffed endotracheal tube.	LMA 2 Airway secured using a size 2 laryngeal mask airway.	LMA 2.5 Airway secured using a size 2.5 laryngeal mask airway.	LMA 3 Airway secured using a size 3 laryngeal mask airway.	LMA 4 Airway secured using a size 4 laryngeal mask airway.
Overall Study STARTED	13	15	15	33	24
Overall Study COMPLETED	13	15	15	33	24
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Number of participants analyzed in each row is number that received each type of airway.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LMA 2 n=15 Participants Airway secured using a size 2 laryngeal mask airway.	LMA 2.5 n=15 Participants Airway secured using a size 2.5 laryngeal mask airway.	LMA 3 n=33 Participants Airway secured using a size 3 laryngeal mask airway.	LMA 4 n=24 Participants Airway secured using a size 4 laryngeal mask airway.	Cuffed ETT n=13 Participants Airway secured using a cuffed endotracheal tube.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants	24 Participants n=4 Participants	13 Participants n=21 Participants	100 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants	10 Participants n=4 Participants	7 Participants n=21 Participants	52 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	6 Participants n=21 Participants	48 Participants n=8 Participants
Intracuff pressure immediately following intubation	15 cmH2O STANDARD_DEVIATION 13 • n=5 Participants • Number of participants analyzed in each row is number that received each type of airway.	25 cmH2O STANDARD_DEVIATION 10 • n=7 Participants • Number of participants analyzed in each row is number that received each type of airway.	34 cmH2O STANDARD_DEVIATION 10 • n=5 Participants • Number of participants analyzed in each row is number that received each type of airway.	32 cmH2O STANDARD_DEVIATION 10 • n=4 Participants • Number of participants analyzed in each row is number that received each type of airway.	19 cmH2O STANDARD_DEVIATION 26 • n=21 Participants • Number of participants analyzed in each row is number that received each type of airway.	27 cmH2O STANDARD_DEVIATION 15 • n=8 Participants • Number of participants analyzed in each row is number that received each type of airway.

PRIMARY outcome

Timeframe: At time of EGD probe insertion

Population: Number of participants that received each type of airway.

Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.

Outcome measures

Outcome measures
Measure	LMA 2 n=15 Participants Airway secured using a size 2 laryngeal mask airway.	LMA 2.5 n=15 Participants Airway secured using a size 2.5 laryngeal mask airway.	LMA 3 n=33 Participants Airway secured using a size 3 laryngeal mask airway.	LMA 4 n=24 Participants Airway secured using a size 4 laryngeal mask airway.	Cuffed ETT n=13 Participants Airway secured using a cuffed endotracheal tube.
Intracuff Pressures During Probe Insertion	22 cmH2O Standard Deviation 14	34 cmH2O Standard Deviation 9	41 cmH2O Standard Deviation 15	37 cmH2O Standard Deviation 12	24 cmH2O Standard Deviation 25

PRIMARY outcome

Timeframe: At time of EGD while probe is in place

Population: Number of participants analyzed in each row is number that received each type of airway.

Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place.

Outcome measures

Outcome measures
Measure	LMA 2 n=15 Participants Airway secured using a size 2 laryngeal mask airway.	LMA 2.5 n=15 Participants Airway secured using a size 2.5 laryngeal mask airway.	LMA 3 n=33 Participants Airway secured using a size 3 laryngeal mask airway.	LMA 4 n=24 Participants Airway secured using a size 4 laryngeal mask airway.	Cuffed ETT n=13 Participants Airway secured using a cuffed endotracheal tube.
Intracuff Pressure With Probe in Place	22 cmH2O Standard Deviation 14	35 cmH2O Standard Deviation 9	39 cmH2O Standard Deviation 13	36 cmH2O Standard Deviation 11	24 cmH2O Standard Deviation 25

PRIMARY outcome

Timeframe: Immediately after probe removal

Population: Number of participants analyzed in each row is number that received each type of airway.

Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed.