Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04356547 |
| Other study ID # |
F-017-00 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2020 |
| Est. completion date |
March 15, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Universidad de Antioquia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Randomized clinical trial conducted in pediatric simulators that wishes to compare the
success of fiberoptic tracheal intubation using supraglottic device AuraGain compared with
fiberoptic tracheal intubation without laryngeal mask, performed by anesthesiologists and
anesthesiology residents.
Description:
To determine the required sample size, the data reported from studies were studied where the
Auragain device for intubation with fibrobronchoscope in adult patients is studied. In these
studies, an average intubation rate at the first attempt in adults of 87% of all cases was
found compared to an average success rate of intubation with FBC without a supraglottic
device of 60%. Based on these data, and assuming an alpha error of 0.05 of two tails and a
power of 80%, a total number of participants of 82 is required, that is 41 participants per
group. However, being a cross study, a total of 41 participants is required since each
participant will be their own control. For its calculation, the Stata 14.0 program was used
Sample size
Recruitment The recruitment of participants will be carried out by the research group. A
verbal and email invitation will be made to the anesthesiology residents from different
University centers, in addition to the residents of this same specialty of other institutions
that are doing some rotation at the University Hospital San Vicente Foundation or IPS
University Clinic León XIII. In the same way the anesthesiologists of these two health
institutions will be recruited for the study.
Sampling will be carried out for the convenience of consecutive participants until the
necessary number is fulfilled according to the sample design.
After this, the possible participants of the clinical trial will be asked about their
intention to be part of the study, and those interested will be explained the relevant
aspects of this study, including the protocol, objectives, safety aspects and doubts will be
resolved.
Once they accept their participation in the clinical trial, the eligibility criteria to enter
the study will be determined and it will be remembered that they must perform a CUSUM
learning curve for fibrobronchoscopy in pediatric simulators. If the participant accepts the
informed consent, authorizing the proceeding of the study.
A recruitment rate of 4 to 5 participants per week is expected, so a recruitment period of 10
weeks after study approval is calculated.
The strategies used to favor recruitment will be:
- Create a work team with interest in the area and committed to the development of the
study.
- Motivate residents of anesthesiology and anesthesiologists through information boards in
the operating rooms of the San Vicente Foundation University Hospital or IPS University
Clinic León XIII
- Perform a check every two weeks to determine that recruitment goals are being met
It should be clarified that there will be no economic incentive for the patients or the group
of anesthesiologists participating in the study Retention The participants understudy do not
participate in economic stimulation that the incentives to participate or continue in.
Participation will be voluntary, free acceptance of the anesthesiologist or anesthesiology
student, who has understood the scientific benefits of the study and the possible associated
risks.
Losses: Participants who perform the intervention or control and the selected data will be
evaluated immediately after intubation maneuvers. There will be no subsequent measurements
that involve the monitoring of the participants. It is unlikely that participants will be
lost since data collection is immediate, however, and given that complications occur at
different times, there is a the possibility that the participant does not attend one or both
moments of intervention so a loss of 5% of participants is projected.
Withdrawals: Since all participants will be trained with the CUSUM curve, there are no causes
to withdraw participants, the only cause will be that the participant will not wish to
continue the investigation once the informed consent has been completed. In case this happens
by sending a written report to the research coordinator.
Analysis by intention to be treated: Due to the nature of the study, participants can perform
intubation maneuvers with both arms, see this type of analysis by default.
Data management
The plan for handling data, inputs, coding, security, and storage, which guarantee their
quality will be as follows:
- Collection: The researcher who observes the intervention of the participant will record
the data in physical format, then the data recorded in the physical formats will be
subjected to quality control; avoiding loss and error in data entry. This information
will be subject to review by double-checking by two different investigators.
- Sending of the data: Once the data has been collected, they are entered into an
envelope, marked according to the assignment number and the participant's identification
number, and sealed. They will be sent to the data collection center, located in the
Anesthesiology and Resuscitation Section office.
- Coding: The data will be entered in a magnetic medium (Excel © 2010) by an assistant of
the research group, who does not participate in the research directly. A second
assistant performs the double-check, to verify the agreement between the data entered
and the data reported.
- Security: It will be encrypted with a password that only the auxiliaries who collect the
data know. Periodically, the assistants will take a backup to keep the data, with
restricted access for researchers.
- Storage: Envelopes with the information of physical formats will be stored for 2 years
after the end of the study in the office of Anesthesiology and Resuscitation Section.
- Analysis: Once the collection stage is finished and the analysis begins, the data will
be delivered to the researchers with allocation concealment.
18. Statistical method and Analysis Plan. The baseline characteristics will be presented
in Table 1. For quantitative variables, Shapiro Wills normality test will be performed,
and if they are normal, they will be presented by means and standard deviation; if
normality is not demonstrated, they will be presented through medians and interquartile
range. For qualitative variables, it will be presented by frequencies and proportions.
The results will be presented at relative risk with their respective 95% confidence interval,
with the value of p, so Fisher's exact test will be performed. A p-value of less than 0.05
will be considered statistically significant.
For the other outcomes, the statistical analysis will be presented (Outcome, Measures, and
methods of analysis):
Intubation success at first attempt: Incidents Relative Risk Fisher's exact test.
Time in seconds of the intubation maneuver : Mean or median, Difference of means or medians
Student t-test or Mann Whitney U test. In case of non-normality in this variable, it will be
considered to report in the median and a non-parametric test will be carried out as a
hypothesis test.
Global intubation successful: Incidents, Relative Risk Fisher's exact test
Display Degree: Proportion of each grade Relative Risk Chi-square test of homogeneity
Intubation success at the second and third attempt: Incidents Relative Risk Fisher's exact
test
Accidental extubation: Incidents Relative Risk Fisher's exact test Degree of the difficulty
of orotracheal intubation: Proportion of each grade Relative Risk Chi-square test of
homogeneity
Analysis of lost data
Due to the nature of the study, participants will perform intubation maneuvers in both arms,
so it is not possible to perform this type of analysis. A loss should not occur, as the data
will be collected immediately, except in cases of force majeure. Methods of the imputation of
lost data will not be used.
Data monitoring and interim analysis.
The data monitoring will be carried out by the external research committee consisting of 2
anesthesiologists from the Department of Anesthesiology and Resuscitation of the University
of Antioquia and staff of the research institute of the same higher education institutions.
They will have as function:
1. Evaluation and monitoring of recruitment, randomization, adherence to the protocol,
among others.
2. Blindly evaluate and monitor research data and generate recommendations to the research
group. Among the suggested recommendations may be the suspension of the investigation.
3. Interim analysis: They will not be carried out, because the study will be carried out in
simulators, no serious adverse effects are planned and the recruitment time is not
prolonged.
Audit
The data quality audit will be carried out by a person from the Anaesthesiology and
Resuscitation service, who will have the function of:
1. Evaluate the the relevance of data collection formats and databases designated for the
registration of information.
2. Evaluate adherence to the protocol by researchers.
3. An audit will be conducted after the end of the third week of recruitment, taking as a
sample the data of 50% of participants who have entered the study.
The research team must adopt the following measures to guarantee the quality of data
management:
1. Develop a procedure manual that is easily accessible to researchers, with availability
in the simulation service, which clearly states the objectives, eligibility criteria,
outcomes, randomization, and diligence of informed consent.
2. Data collection formats: that contain clear information and that are agile to complete.
3. Training and evaluation of the research team to ensure homogeneity in the application of
the protocol.
4. Double review of the data that is transferred from the physical medium to the magnetic
medium. Storage of physical data to be reviewed in case of loss of data in
electromagnetic media.
