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Influence of an endotracheal tube with subglottic suction and continuous cuff pressure measurement on the pulmonary microbiome of ventilated intensive care patients

Influence of an endotracheal tube with subglottic suction and continuous cuff pressure measurement on the pulmonary microbiome of ventilated intensive care patients - TUBOMIC-Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029176
Enrollment
50
Registered
2022-07-07
Start date
2022-12-03
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

J95.88

Interventions

Group 1: For one group (intervention group), the Venner PneuX™ tube system with subglottic suctioning will be used. The observation will take place over a ventilation period of 4-5 days. As part of a

Sponsors

Universitätsklinikum Heidelberg Klinik für Anästhesiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: All patients requiring intubation and ventilation due to acute respiratory failure in the Surgical Clinic of Heidelberg University Hospital during the study period will be included. A total of 50 patients will be included in the study. Inclusion will be in chronological order. The following criteria must be met: Acute respiratory failure Need for airway protection by a tube for invasive ventilation Age >18 years Written informed consent by legally appointed representative.

Exclusion criteria

Exclusion criteria: Exclusion criteria are defined as: Refusal to participate in the study Pregnancy Age <18 years

Design outcomes

Primary

MeasureTime frame
Study of the changes in the pulmonary microbiome. Study of the changes of the microbiome in correlation with clinically relevant complications.

Secondary

MeasureTime frame
Evaluation of the prognostic value of microbiome analysis. Correlation between pathogen diagnostics via NGS (next generation sequencing) and culture based. Investigation of changes in pulmonary immune cells. Investigation of changes in the pulmonary metabolome. Investigation of a possible correlation between patient immune status, microbiome and metabolome. Outecomeevaluation after 28 days.

Countries

Germany

Contacts

Public ContactMascha O. Fiedler-Kalenka

Universitätsklinikum Heidelberg Klinik für Anästhesiologie

Mascha.fiedler-kalenka@med.uni-heidelberg.de004962215639434

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 3, 2026