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Continuous balloon pressure monitoring can reduce the incidence of tracheal mucosal injury in patients undergoing thyroid surgery: a randomized controlled trial.

Continuous balloon pressure monitoring can reduce the incidence of tracheal mucosal injury in patients undergoing thyroid surgery: a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078791
Enrollment
Unknown
Registered
2023-12-19
Start date
2023-12-22
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Tracheal mucosal injury in patients undergoing thyroid surgery

Interventions

Intervention group and control group:If the endotracheal cuff pressure exceeds 30 cmH2O for >30 s (excluding artificial changes), reduce the volume of the cuff until the pressure returns to the initia
this constitutes an intervention. If the tracheal cuff pressure is below 20 cmH2O for >30 s (excluding artificial changes), increase the cuff volume until the pressure returns to the initial level.
Control group:The pressure in the tracheal cannula cuff was measured continuously during the procedure, but no intervention was performed.

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: ASA classification I-II; age range; Between 20-75 years old; planned to undergo intubation under general anesthesia; operation time is 60-150 minutes; patients with thyroid tumors.

Exclusion criteria

Exclusion criteria: Body mass index (BMI) 30kg/m2, language communication and understanding difficulties, tracheal anatomy variations, expected or two tracheal intubations (requiring more than two attempts), recent history of respiratory tract infection or pharyngitis, preoperative use Steroids and analgesics.

Design outcomes

Primary

MeasureTime frame
Airway mucosal damage;

Secondary

MeasureTime frame
Sore throat after surgery;Cough after surgery;Hoarseness after surgery;

Countries

China

Contacts

Public ContactHongfei Chen

The First Affiliated Hospital of Wenzhou Medical University

chhfei@126.com+86 136 9580 2515

Outcome results

None listed

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