Trial Outcomes & Findings for Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning (NCT NCT01069185)

Results Overview

All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .

Results posted on

2017-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	Necessity Endotracheal Suctioning Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations	Routine Endotracheal Suctioning Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours
Overall Study STARTED	47	45
Overall Study COMPLETED	47	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Necessity Endotracheal Suctioning n=606 suctioning number Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations	Routine Endotracheal Suctioning n=649 suctioning number Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours	Total n=1255 suctioning number Total of all reporting groups
Age, Continuous	34 months n=5 Participants	56 months n=7 Participants	40.5 months n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Weight	15 Kgs n=5 Participants	15 Kgs n=7 Participants	15 Kgs n=5 Participants
PRISM	23 units on a scale n=5 Participants	23 units on a scale n=7 Participants	23 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .

All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.

Outcome measures

Outcome measures
Measure	Necessity Endotracheal Suctioning n=606 suctioning Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations	Routine Endotracheal Suctioning n=649 suctioning Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours
Primary Composite End Point	35 event	48 event

SECONDARY outcome

Timeframe: Every day while patient really is intubated.

Number of days under mechanical ventilation during ICU hospitalization length

Outcome measures

Outcome measures
Measure	Necessity Endotracheal Suctioning n=47 Participants Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations	Routine Endotracheal Suctioning n=45 Participants Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours
Mechanical Ventilation Length as Days.	2.5 Days Interval 1.0 to 5.0	2.4 Days Interval 0.8 to 6.4

Adverse Events

Necessity Endotracheal Suctioning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Routine Endotracheal Suctioning

Serious events: 1 serious events

Other events: 0 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Necessity Endotracheal Suctioning n=45 participants at risk；n=47 participants at risk Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations	Routine Endotracheal Suctioning n=47 participants at risk；n=45 participants at risk Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours
Respiratory, thoracic and mediastinal disorders VAP	0.00% 0/47	2.2% 1/45 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr.Jorge Donado Research Unit Chief

Pablo Tobon Uribe Hospital

Phone: +574459753

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place