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The COVID-19 pandemic and the development of a device with a 3D printing technique to assit in intubating patients at the university hospital

The COVID-19 pandemic and the development of a 3D videolaryngoscope for a University hospital -

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9gpm9hy
Enrollment
Unknown
Registered
2022-02-15
Start date
2021-09-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

This clinical trial will be performed by contrasting the device developed at the Universidade Federal Fluminense with direct laryngoscopy performed with Macintosh blade. Patients will undergo general
2. Ease of visualization of the glottis using the Cormack-Lehane scale
3.Possible harm caused to patients The length of professional experience of the executor will also be indicated. All evaluations will be registered in an individual form. As the hospital has a reduced

Sponsors

Hospital Universitário Antônio Pedro - Universidade Federal Fluminense
Lead Sponsor
Hospital Universitário Antônio Pedro - Universidade Federal Fluminense
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers of all genders; over 18 years of age; with physical status classification I, II or III by the American Society of Anesthesiology; Mallampati (scale to assess the airway) I, II and III; submitted to elective surgeries under general anesthesia

Exclusion criteria

Exclusion criteria: Emergency surgical procedures; patients with decompensated arterial disease or hemodynamic instability; volunteers rated IV on the Mallampati scale

Design outcomes

Primary

MeasureTime frame
Evaluate the safe and effective use of the 3D videolaryngoscope developed by the engineering school of the Universidade Federal Fluminense in patients undergoing elective surgical procedures. It is expected that such device may be used in the orotracheal intubation procedures of COVID-19 patients admitted to Hospital Universitário Antônio Pedro. The variables studied will be: 1) number of intubation attempts; 2) ease of the Federal University of Rio de Jane in intubation procedures orotracheal examination of COVID-19 patients admitted to Hospital Universitário Antônio Pedro.The variables studied will be: 1. number of intubation attempts; 2. ease of visualization of the glottis by the Cormack-Lehane scale; 3. Possible damage to the patients. All the evaluations will be registered on individual sheets. The data recorded in the form will be compared and statistically calculated. For the sample calculation, we used an alpha of 0.05, beta of 0.2 and a standard deviation of 0.7, thus, 30 patients per group would have 80% of testing power to find a difference of one point on the Cormack-Lehane scale between the group with higher and lower variability. Thus, the sample size includes 60 patients, with 30 patients per group. The Shapiro-Wilk normality test will be performed to see if the number of intubation attempts and the assessment of the modified Cormack-Lehane scale have normal distribution. If so,If so, these variables will be expressed as mean and standard deviation and will be compared between groups using the student t-test. Otherwise, they will be presented with median and interquartile range and the comparison will be by the Mann-Whitney test. The categorical data referring to possible damage will be evaluated descriptively and expressed as frequency and percentage. The significance level used will be 0.05. The data will be analyzed using the SPSS Statistics 20- IBM program.

Secondary

MeasureTime frame
It is hoped to include the 3D video laryngoscope to the arsenal of airway management devices at the University Hospital.

Countries

Brazil

Contacts

Public ContactAndréa Silva

Hospital Universitário Antônio Pedro - Universidade Federal Fluminense

zajsjpac@gmail.com+55(21) 26299090

Outcome results

None listed

Source: REBEC (via WHO ICTRP)