Trial Outcomes & Findings for The Effect of Prolonged Inspiratory Time on Pulmonary Mechanics in Obese Patients (NCT NCT02961920)

NCT ID: NCT02961920

Last Updated: 2019-11-05

Results Overview

ten minutes after tracheal intubation to 90 min after prone position

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: ten minutes after tracheal intubation to 90 min after prone position
• Results posted on: 2019-11-05

Participant Flow

Between November 2016 and October 2018, 50 patients who underwent lumbar spine surgery in our institution were assessed. Two patients dropped out. Thus, 48 patients achieved study protocol.

Participant milestones

Measure	IE Ratio 1:2 Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.	IE Ratio 1:1 Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.
Overall Study STARTED	25	25
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	IE Ratio 1:2 Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.	IE Ratio 1:1 Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.
Overall Study did not achive stydy protocol schedule	1	1

Baseline Characteristics

The Effect of Prolonged Inspiratory Time on Pulmonary Mechanics in Obese Patients

Baseline characteristics by cohort

Measure	IE Ratio 1:1 n=24 Participants Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients. IE ratio 1:1: Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.	IE Ratio 1:2 n=24 Participants Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients. IE ratio 1:2: Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.	Total n=48 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	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 10 • n=5 Participants	54.6 years STANDARD_DEVIATION 13 • n=7 Participants	53.42 years STANDARD_DEVIATION 9.89 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Korea	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
body mass index	27.4 kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants	28.7 kg/m^2 STANDARD_DEVIATION 2.7 • n=7 Participants	28.13 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: ten minutes after tracheal intubation to 90 min after prone position

ten minutes after tracheal intubation to 90 min after prone position

Outcome measures

Measure	IE Ratio 1:2 n=24 Participants Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients. IE ratio 1:2: Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.	IE Ratio 1:1 n=24 Participants Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients. IE ratio 1:1: Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.
PaO2(Partial Pressure of Oxygen in Arterial Blood) paO2 30min	178.71 mmHg Standard Deviation 36.43	198.04 mmHg Standard Deviation 17.667
PaO2(Partial Pressure of Oxygen in Arterial Blood) PaO2 90min	185.25 mmHg Standard Deviation 26.54	202.54 mmHg Standard Deviation 17.627

Adverse Events

IE Ratio 1:2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IE Ratio 1:1

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 Junju Choi

Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University

Phone: 82324603624

Email: jjchoi2@gilhospital.com

Results disclosure agreements

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