Mechanical Ventilation Complication
Conditions
Keywords
Prone position ventilation, Endotracheal intubation, Displacement
Brief summary
In this study, the investigators adopt the special endotracheal tube to those patients at prone posture during the operation,or those with acute respiratory distress syndrome in the intensive care unit(ICU), so that the investigators can reduce, or even avoid some severe complications during perianesthesia, and that the investigators can provide strong safeguard measures for the respiratory therapy of critical patients in ICU.
Detailed description
The investigators apply some technical proposals to make it come true:one kind of special endotracheal tube, including traditional endotracheal tube,fixed device,fixed rope,two through holes.With this tube ,the investigators can keep away shifting and falling off of traditional air tube,so that the investigators can try to avoid disaster events.And for the patients with acute respiratory disease syndrome(ARDS),they are always given ventilation in prone position,so it may be beneficial.
Interventions
DEVICEprone position endotracheal tube(PPT)
some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes
Sponsors
Central South University
Wangyuan Zou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- those who are about to undergo the surgery at prone posture,especially in neurosurgery and spine surgery，American society of anesthesia(ASA) grade I-II，aged from 18 to 65 years old,weight ranged from 50 to 75 kilograms.
Exclusion criteria
* No meeting inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Displacement of the Endotracheal Tube | Participants were followed for the duration of surgery, an average of 2 hours. | We divided the degree of the displacement of the endotracheal tube into 3 kinds, which included mild(displacement distance\<0.5cm),moderate(0.5cm≤displacement distance\<1.5cm),severe (1.5cm≤displacement distance). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of the Prolapse of Endotracheal Tube | At any time within the procedure of the whole surgery | Counting the number who occured the prolapse of endotracheal tube in both groups |
| the Degree of Loose or Dampness of the Tape | at the time when patients were turning to supine position | counting and quantifying the number who occured the dampness or loose of the tape in both groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| the Incidence of Dysphagia | within the first 24 hours after extubation | count the number who suffered the dysphagia within the first 24 hours after extubation |
| the Incidence of Sore Throat | within the first 24 hour after extubation | count the number who suffer sore throat within the first 24 hour after extubation |
| the Incidence of Dysphonia | within the first 24 hour after extubation | count the number who suffered dysphonia within the first 24 hour after extubation |
Countries
China
Participant flow
Recruitment details
We have 80 adult patients as candidates who were undergoing the neurosurgery or spinal surgery in Xiangya Hospital affiliated to Central South University between Mar 11, 2014 and Mar 16, 2016. These participants were graded American society of anesthesia(ASA)I-II,and aged 30-70 years old,weighted ranging from 50 to 75 kilograms.
Pre-assignment details
We finally enrolled 60 patients for our trail. Among the 80 candidates, 7 patients couldn't meet our inclusion criteria; the other 13 patients refused to participate in this trail at last.
Participants by arm
| Arm | Count |
|---|---|
| Prone Position Endotracheal Tube(PPT) We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the prone position endotracheal tube group(PPT), in which group the patients were intubated with the custom-designed endotracheal tube. | 30 |
| Traditional Endotracheal Tube(TT) We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the traditional endotracheal tube group(TT), in which group the patients were intubated with the routine endotracheal tube. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Traditional Endotracheal Tube(TT) | Prone Position Endotracheal Tube(PPT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 47 yr STANDARD_DEVIATION 6 | 49 yr STANDARD_DEVIATION 5 | 48 yr STANDARD_DEVIATION 6 |
| Region of Enrollment China | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 30 | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Displacement of the Endotracheal Tube
We divided the degree of the displacement of the endotracheal tube into 3 kinds, which included mild(displacement distance\<0.5cm),moderate(0.5cm≤displacement distance\<1.5cm),severe (1.5cm≤displacement distance).
Time frame: Participants were followed for the duration of surgery, an average of 2 hours.
Population: All patients in each group were analyzed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prone Ventilation Endotracheal Tube | Displacement of the Endotracheal Tube | The overall incidence of displacement | 0 Participants |
| Prone Ventilation Endotracheal Tube | Displacement of the Endotracheal Tube | Mild displacement | 0 Participants |
| Prone Ventilation Endotracheal Tube | Displacement of the Endotracheal Tube | Moderate displacement | 0 Participants |
| Prone Ventilation Endotracheal Tube | Displacement of the Endotracheal Tube | Severe displacement | 0 Participants |
| the Traditional Endotracheal Tube | Displacement of the Endotracheal Tube | Severe displacement | 3 Participants |
| the Traditional Endotracheal Tube | Displacement of the Endotracheal Tube | The overall incidence of displacement | 22 Participants |
| the Traditional Endotracheal Tube | Displacement of the Endotracheal Tube | Moderate displacement | 8 Participants |
| the Traditional Endotracheal Tube | Displacement of the Endotracheal Tube | Mild displacement | 11 Participants |
p-value: <0.05Chi-squared
Secondary
the Degree of Loose or Dampness of the Tape
counting and quantifying the number who occured the dampness or loose of the tape in both groups
Time frame: at the time when patients were turning to supine position
Population: all participants in both groups were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prone Ventilation Endotracheal Tube | the Degree of Loose or Dampness of the Tape | 7 Participants |
| the Traditional Endotracheal Tube | the Degree of Loose or Dampness of the Tape | 0 Participants |
Secondary
The Number of the Prolapse of Endotracheal Tube
Counting the number who occured the prolapse of endotracheal tube in both groups
Time frame: At any time within the procedure of the whole surgery
Population: All participants in both groups were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prone Ventilation Endotracheal Tube | The Number of the Prolapse of Endotracheal Tube | 0 Participants |
| the Traditional Endotracheal Tube | The Number of the Prolapse of Endotracheal Tube | 0 Participants |
p-value: >0.05Chi-squared
Other Pre-specified
the Incidence of Dysphagia
count the number who suffered the dysphagia within the first 24 hours after extubation
Time frame: within the first 24 hours after extubation
Population: all patients were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prone Ventilation Endotracheal Tube | the Incidence of Dysphagia | 0 Participants |
| the Traditional Endotracheal Tube | the Incidence of Dysphagia | 0 Participants |
Other Pre-specified
the Incidence of Dysphonia
count the number who suffered dysphonia within the first 24 hour after extubation
Time frame: within the first 24 hour after extubation
Population: all patients in both groups were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prone Ventilation Endotracheal Tube | the Incidence of Dysphonia | 0 Participants |
| the Traditional Endotracheal Tube | the Incidence of Dysphonia | 0 Participants |
Other Pre-specified
the Incidence of Sore Throat
count the number who suffer sore throat within the first 24 hour after extubation
Time frame: within the first 24 hour after extubation
Population: all patients in both groups were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prone Ventilation Endotracheal Tube | the Incidence of Sore Throat | 1 Participants |
| the Traditional Endotracheal Tube | the Incidence of Sore Throat | 1 Participants |