Trial Outcomes & Findings for Intensive Alveolar Recruitment Protocol After Cardiac Surgery (NCT NCT01502332)

Results Overview

Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication. The comparison used this ordinal variable, representing the highest score achieved during the post-operative period. The comparison between arms was made through the Mann-Whitney U test. Data shown are percentage of participants with pulmonary complications grade ≥ 3.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

320 participants

Primary outcome timeframe

Participants were followed for the duration of hospital stay.

Results posted on

2016-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Intensive Alveolar Recruitment Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.	Moderate Alveolar Recruitment Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
Overall Study STARTED	157	163
Overall Study COMPLETED	157	163
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intensive Alveolar Recruitment Protocol After Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive Alveolar Recruitment n=157 Participants Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.	Moderate Alveolar Recruitment n=163 Participants Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.	Total n=320 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Age, Categorical >=65 years	57 Participants n=5 Participants	63 Participants n=7 Participants	120 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants	63 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	66 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	97 Participants n=7 Participants	195 Participants n=5 Participants
Region of Enrollment Brazil	157 participants n=5 Participants	163 participants n=7 Participants	320 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were followed for the duration of hospital stay.

Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication. The comparison used this ordinal variable, representing the highest score achieved during the post-operative period. The comparison between arms was made through the Mann-Whitney U test. Data shown are percentage of participants with pulmonary complications grade ≥ 3.

Outcome measures

Outcome measures
Measure	Intensive Alveolar Recruitment n=157 Participants Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.	Moderate Alveolar Recruitment n=163 Participants Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
Severity of Pulmonary Complications in the Post-operative Period	15 percentage of participants	26 percentage of participants

SECONDARY outcome

Timeframe: From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery

Days since surgery until ICU discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the ICU. The censoring was performed at 28 days. Patients dying before leaving the ICU were censored as not discharged from ICU at day 28.

Outcome measures

Outcome measures
Measure	Intensive Alveolar Recruitment n=157 Participants Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.	Moderate Alveolar Recruitment n=163 Participants Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
Length of ICU Stay	3 days Interval 2.0 to 4.0	3 days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery

Days since surgery until Hospital discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the Hospital. The censoring was performed at 28 days. Patients dying before leaving the Hospital were censored as not discharged from Hospital at day 28.

Outcome measures

Outcome measures
Measure	Intensive Alveolar Recruitment n=157 Participants Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.	Moderate Alveolar Recruitment n=163 Participants Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
Length of Hospital Stay	8 days Interval 7.0 to 12.0	9 days Interval 7.0 to 14.0

SECONDARY outcome

Timeframe: Five days after surgery

Confirmed by X-ray. Test with logistic regression

Outcome measures

Outcome measures
Measure	Intensive Alveolar Recruitment n=157 Participants Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.	Moderate Alveolar Recruitment n=163 Participants Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
Incidence of Barotrauma	0 percentage of participants	1 percentage of participants

SECONDARY outcome

Timeframe: From the day of surgery up to Hospital discharge or death, with no maximum censoring.

Deaths occurred during hospital stay, tested with logistic regression.

Outcome measures

Outcome measures
Measure	Intensive Alveolar Recruitment n=157 Participants Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.	Moderate Alveolar Recruitment n=163 Participants Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
Hospital Mortality	3 percentage of participants	5 percentage of participants

Adverse Events

Intensive Alveolar Recruitment ARM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate Alveolar Recruitment ARM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Alcino Costa Leme

USaoPaulo

Phone: 55 11 989044014

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place