Trial Outcomes & Findings for Effect of Mechanical Ventilation on Plasma Concentration Level of R-spondin Proteins (NCT NCT03315702)

Last Updated: 2019-07-25

Results Overview

The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin1 concentration. And the outcome was calculated by subtracting the R-spondin1 plasmid concentration of sample A from the R-spondin1 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin1.

Recruitment status

COMPLETED

Target enrollment

52 participants

Primary outcome timeframe

3 hours

Results posted on

2019-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Control／Mechanical Ventilation venous blood samples collected from patients twice，relatively before mechanical ventilation and 3rd hour after mechanical ventilation
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Mechanical Ventilation on Plasma Concentration Level of R-spondin Proteins

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control／Mechanical Ventilation n=52 Participants venous blood samples collected from patients twice，relatively before mechanical ventilation and 3rd hour after mechanical ventilation mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cm h2o, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	52 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 hours

Outcome measures

Outcome measures
Measure	Control／Mechanical Ventilation n=52 Participants Venous blood samples collected from patients twice before mechanical ventilation and 3rd hour after mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.
Change in Plasma Concentration of R-spondin 1	1407.4080 pg/ml Standard Deviation 1350.7859

PRIMARY outcome

Timeframe: 3 hours

The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin2 concentration. And the outcome was calculated by subtracting the R-spondin2 plasmid concentration of sample A from the R-spondin2 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin2.

Outcome measures

Outcome measures
Measure	Control／Mechanical Ventilation n=52 Participants Venous blood samples collected from patients twice before mechanical ventilation and 3rd hour after mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.
Change in Plasma Concentration of R-spondin 2	-2.1830 pg/ml Standard Deviation 35.3601

PRIMARY outcome

Timeframe: 3 hours

The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin3 concentration. And the outcome was calculated by subtracting the R-spondin3 plasmid concentration of sample A from the R-spondin3 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin3.

Outcome measures

Outcome measures
Measure	Control／Mechanical Ventilation n=52 Participants Venous blood samples collected from patients twice before mechanical ventilation and 3rd hour after mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.
Change in Plasma Concentration of R-spondin3	-2.8956 pg/ml Standard Deviation 30.2781

PRIMARY outcome

Timeframe: 3 hours

The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin4 concentration. And the outcome was calculated by subtracting the R-spondin4 plasmid concentration of sample A from the R-spondin4 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin4.

Outcome measures

Outcome measures
Measure	Control／Mechanical Ventilation n=52 Participants Venous blood samples collected from patients twice before mechanical ventilation and 3rd hour after mechanical ventilation: mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.
Change in Plasma Concentration of R-spondin4	-269.8598 pg/ml Standard Deviation 1230.6612

Adverse Events

Control／Mechanical Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control／Mechanical Ventilation n=52 participants at risk Venous blood samples were collected twice for each patient，relatively before onset of mechanical ventilation and 3rd hour after mechanical ventilation.
General disorders 0	0.00% 0/52 • 3 hours Explanation: The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation. Samplings of 1 ml blood were performed twice per patient from peripheral venous catheter: the first just before endotracheal intubation and the second 3rd hour after that. Systematic monitoring, including electrocardiograph monitoring, brain electricity guardianship, blood gas，blood pressure, etc., was performed during surgery process. Patients responded normally with stable postoperative consciousness. No death, serious or other adverse events occurred during this process in surgical room.

Additional Information

Dr. Lai Jiang

Department of Anesthesia, Xinhua hospital affiliated to Shanghai Jiaotong University School of medicine

Phone: 021-25078999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place