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Comparison of Flow-Volume Loop and Traditional Finger Palpation for Tracheal Tube Cuff Inflation in Children

Comparison of Flow-Volume Loop and Traditional Finger Palpation for Tracheal Tube Cuff Inflation in Children: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127050
Enrollment
Unknown
Registered
2026-06-23
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

H0118 Other scientific issues related to respiratory diseases

Interventions

GroupA:When using this method, the anesthesiologist inflates the cuff while pressing the pilot balloon with a fingertip to adjust cuff pressure, until the tension of the pilot balloon feels comparable
GroupB:Observe real-time changes in the flow-volume loop on the monitor of the anesthetic machine’s closed circuit. Inflate the cuff using the fractional air injection method with 0.5 mL of air inject
record the initial cuff pressure (P?) at this moment. Next, withdraw air from the cuff incrementally at 0.2 mL per time until the flow-volume loop opens again (air leakage occurs). Then reinflate the

Sponsors

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged 3 to 12 years; 2. gender unrestricted; 3. pediatric patients scheduled for surgery under general anesthesia with tracheal intubation; 4. American Society of Anesthesiologists (ASA) physical status class 1–2; 5. written informed consent voluntarily signed by the patient or their legal guardian

Exclusion criteria

Exclusion criteria: 1. Age 12 years; 2. predicted difficult intubation (Mallampati class = III); 3. anatomical airway abnormalities (e.g., tracheal stenosis, tracheoesophageal fistula); 4. underlying respiratory diseases (asthma, bronchopulmonary dysplasia); 5. high risk of aspiration (ASA class = III with gastric emptying disorder); 6. recent respiratory tract infection (fever, cough, sore throat, hoarseness, etc., within 2 weeks before surgery); 7. patient or legal guardian refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
endotracheal tube cuff pressure;Tracheal mucosal injury;sore throat hoarseness cough stridor;

Countries

China

Contacts

Public ContactXiao Zhang

Shanghai Children's Medical Center

18262859277@163.com+86 182 6285 9277

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026