Trial Outcomes & Findings for Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet (NCT NCT00912990)

Results Overview

Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

Confirmed by the visualization of three carbon dioxide waveforms.

Results posted on

2020-08-18

Participant Flow

Subjects were screened and enrolled at a single, pediatric hospital site.

Participant milestones

Participant milestones
Measure	Cisatracurium Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation. Cisatracurium : One intravenous dose: 0.2mg/kg/dose	Normal Saline Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg Normal saline : One Intravenous dose
Overall Study STARTED	16	18
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cisatracurium n=16 Participants Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation. Cisatracurium : One intravenous dose: 0.2mg/kg/dose	Normal Saline n=18 Participants Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg Normal saline : One Intravenous dose	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	18 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Confirmed by the visualization of three carbon dioxide waveforms.

Population: Unable to summarize data or complete analysis due to small study sample and technical problems with measurement leading to unreliable data.

Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Recorded from the start of the intubation procedure to the time of successful endotracheal intubation

Population: No further statistical analysis (intent-to-treat) completed due to small study sample.

The number of occurrences of each event. One subject may have multiple adverse events.

Outcome measures

Outcome measures
Measure	Cisatracurium n=16 Participants Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation. Cisatracurium : One intravenous dose: 0.2mg/kg/dose	Normal Saline n=18 Participants Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg Normal saline : One Intravenous dose
The Number of Adverse Events	0 events	3 events

OTHER_PRE_SPECIFIED outcome

Timeframe: The number is totaled after successful endotracheal intubation is documented

Population: Unable to analyze data due to small study sample.

The total number of intubation attempts to achieve successful intubation of study participants.

Outcome measures

Outcome data not reported

Adverse Events

Cisatracurium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cisatracurium n=16 participants at risk Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation. Cisatracurium : One intravenous dose: 0.2mg/kg/dose	Normal Saline n=18 participants at risk Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg Normal saline : One Intravenous dose
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/16	5.6% 1/18 • Number of events 1
Respiratory, thoracic and mediastinal disorders Participant movement/cough/gag	0.00% 0/16	5.6% 1/18 • Number of events 1
Respiratory, thoracic and mediastinal disorders Esophageal intubation	0.00% 0/16	5.6% 1/18 • Number of events 1

Additional Information

Dr. Sandeep Khanna

Rady Children's Hospital San Diego

Phone: 858-966-5863

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place