Trial Outcomes & Findings for Efficacy and Safety of a Lung Recruitment Protocol in Children With Acute Lung Injury (NCT NCT00830284)

Results Overview

PaO2 + PaCO2 of 400 or higher.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

2 hours

Results posted on

2019-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	Recruitment Patients with hypoxic respiratory failure Recruitment maneuver: Three types of maneuvers will be performed. 1. 6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level. 2. 6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level. 3. PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of a Lung Recruitment Protocol in Children With Acute Lung Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recruitment n=10 Participants Patients with hypoxic respiratory failure Recruitment maneuver: Three types of maneuvers will be performed. 1. 6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level. 2. 6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level. 3. PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher.
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	9.35 years STANDARD_DEVIATION 2.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Patients had to meet the ALI criteria	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

PaO2 + PaCO2 of 400 or higher.

Outcome measures

Outcome measures
Measure	Recruitment n=10 Participants Patients with hypoxic respiratory failure Recruitment maneuver: Three types of maneuvers will be performed. 1. 6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level. 2. 6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level. 3. PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher.
Oxygenation	10 Participants

SECONDARY outcome

Timeframe: 4 hours

Incidences of lack of airleak - defined as pneumothorax requiring intervention cardiac compromise - requiring change in pressor support respiratory acidosis - pH \< 7.20

Outcome measures

Outcome measures
Measure	Recruitment n=10 Participants Patients with hypoxic respiratory failure Recruitment maneuver: Three types of maneuvers will be performed. 1. 6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level. 2. 6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level. 3. PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher.
Number of Participants With Ventilator Induced Lung Injury	0 Participants

Adverse Events

Recruitment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Kheir

Boston Children's Hospital

Phone: 6179194712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place