Clinical quality assurance study to review recommendations for insertion depths of nasally inserted endotracheal tubes in premature and full term infants

Clinical quality assurance study to review recommendations for insertion depths of nasally inserted endotracheal tubes in premature and full term infants - ETT-depth quality check

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027286

Enrollment

150

Registered

2021-11-25

Start date

2021-08-23

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

invasive ventilation

Interventions

Group 1: Orientation of the intubation depth based on the weight, if no weight is available (e.g. in the delivery room) based on the gestational age. Group 2: Amendment 02/11/2022: Alternatively, the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Premature infants and newborns who are intubated within one year (e.g. June 2021 up to and including May 2022) due to clinical indications according to local standards.

Exclusion criteria

Exclusion criteria: Malformations in the upper respiratory tract, cervical spine or in the thoracic skeleton that impair the predictability of the reference values

Design outcomes

Primary

Measure	Time frame
Percentage of the correctly inserted endotracheal tubes when using the above diagrams (both together), defined as: ETT tip projection in the X-ray between the middle of the vertebral body T1 and the middle of the vertebral body T3.	—

Secondary

Measure	Time frame
- Percentage of the correctly inserted endotracheal tubes, separated to the two graphics (PMA or weight), defined as: ETT tip projection in the X-ray between the middle of the vertebral body T1 and the middle of the vertebral body T3. If there is a difference in the forecast values ??of the two graphs of> 20%, a test for statistical significance will be carried out. - To determine the risk factors for a wrong recommendation, the weight and length percentiles will be detected to determine whether there was hyper- / hypotrophy and in which diagram this possibly led to an increased occurrence of incorrect positions. Amendment 02/11/2022: - Percentage representation of the correctly inserted endotracheal tubes when using other orientations (e.g. tip marking of the ETT by the manufacturer). A test for statistical significance will be carried out, if there is a difference of >15% compared to the main plots.	—

Measure

Time frame

- Percentage of the correctly inserted endotracheal tubes, separated to the two graphics (PMA or weight), defined as: ETT tip projection in the X-ray between the middle of the vertebral body T1 and the middle of the vertebral body T3. If there is a difference in the forecast values ??of the two graphs of> 20%, a test for statistical significance will be carried out. - To determine the risk factors for a wrong recommendation, the weight and length percentiles will be detected to determine whether there was hyper- / hypotrophy and in which diagram this possibly led to an increased occurrence of incorrect positions. Amendment 02/11/2022: - Percentage representation of the correctly inserted endotracheal tubes when using other orientations (e.g. tip marking of the ETT by the manufacturer). A test for statistical significance will be carried out, if there is a difference of >15% compared to the main plots.

—

Countries

Germany

Contacts

Public ContactChristian A. Maiwald

Abteilung für Neonatologie

christian.maiwald@med.uni-tuebingen.de07071 29 81418

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026