Trial Outcomes & Findings for Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation (NCT NCT01279564)

NCT ID: NCT01279564

Last Updated: 2016-07-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2016-07-27

Participant Flow

Adult consenting patients that were admitted to Rambam Health Care Campus for laparoscopic sleeve gastrectomy were recruited between February and December 2011

All recruited patients were enrolled in the study, no one was excluded.

Participant milestones

Measure	ETview Endotracheal intubation with ETview TVT ETview TVT endotracheal tube: intubation	Control Intubation Endotracheal tube- standard
Overall Study STARTED	40	32
Overall Study COMPLETED	40	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation

Baseline characteristics by cohort

Measure	ETview n=40 Participants Endotracheal intubation with ETview TVT ETview TVT endotracheal tube: intubation	Control n=32 Participants Intubation Endotracheal tube: Intubation	Total n=72 Participants Total of all reporting groups
Age, Continuous	43.1 years STANDARD_DEVIATION 4.9 • n=5 Participants	42.5 years STANDARD_DEVIATION 3.2 • n=7 Participants	42.8 years STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: The induction of general anesthesia, on the operating day (first day)

Time between introducing the laryngoscope and inflation of tube's cuff

Outcome measures

Measure	ETview n=40 Participants Endotracheal intubation with ETview TVT Duration of intubation	Control n=32 Participants Intubation Duration of intubation
Duration of Endotracheal Intubation	29 seconds Standard Deviation 10	24 seconds Standard Deviation 8

Adverse Events

ETview

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	ETview n=40 participants at risk Endotracheal intubation with ETview TVT ETview TVT endotracheal tube: intubation No adverse events	Control n=32 participants at risk Intubation Endotracheal tube: Intubation No adverse events
Respiratory, thoracic and mediastinal disorders Difficult intubation or ventilation	0.00% 0/40 • 1 year No adverse events	0.00% 0/32 • 1 year No adverse events

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michal Barak

Rambam Health Care Campus

Phone: 972 4 8542487

Email: m_barak@rambam.health.gov.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60