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Tracheostomy and Feeding Tube removal Study

Tracheostomy and Feeding Tube Removal Following Elective Surgery for Oral Cancer: A Quality Improvement Initiative and Delphi Consensus - Tracheostomy & RT removal Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/104707
Enrollment
260
Registered
2026-02-25
Start date
Unknown
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

Health Condition 1: C069- Malignant neoplasm of mouth, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Retrospective Part of study Step I. Baseline audit Step II. Protocol-based intervention with re-audit Inclusion Criteria - Adults more than 18 years of age - Histologically proven oral cancer - Temporary tracheostomy and/or feeding tube placement Prospective Part of Study Step III. Modified Delphi consensus process Inclusion Criteria - Clinical experts with minimum 5 years experience in, 1.Head and neck surgical oncology 2.Reconstructive surgery 3.Speech and language therapy i.e. SLT 4.Clinical nutrition or dietetics 5.Tracheostomy care i.e. ENT or Anesthetists or ICU 6.Radiation Oncologists or Medical Oncologists - Representation from various geographic regions and institutions, to ensure diversity.

Exclusion criteria

Exclusion criteria: Retrospective Part of study Step I. Baseline audit Step II. Protocol-based intervention with re-audit Exclusion Criteria - Permanent tracheostomy - Palliative cases - Incomplete records Prospective Part of Study Step III. Modified Delphi consensus process Exclusion Criteria - Non-clinicians or those with more than 5 years of experience in head and neck cancer care. - Industry representatives.

Design outcomes

Primary

MeasureTime frame
1.Median duration of tracheostomy tube retention 2.Median duration of feeding tube retention Timepoint: Step I January 2023 to December 2025 Retrospective audit of around 140 patient records to assess current tracheostomy and feeding tube practices. Step II February to November 2025 Post intervention re audit of around 120 patients daily after implementation of standardized decannulation and tube removal protocol. Step III Delphi consensus with three online rounds and a final in person or virtual meeting to finalize best practice recommendations.

Secondary

MeasureTime frame
1.Tube related complication rates 2.Feeding tube dependence at 6 months 3.Speech & swallowing related quality of life Timepoint: Step I January 2023 to December 2025 Retrospective audit of around 140 patient records to assess current tracheostomy & feeding tube practices. Step II February to November 2025 Post intervention re audit of around 120 patients daily after implementation of standardized decannulation & tube removal protocol. Step III Delphi consensus with three online rounds & a final in person or virtual meeting to finalize best practice recommendations.

Countries

India

Contacts

Public ContactDr ShivaKumar Thiagarajan

TATA MEMORIAL HOSPITAL

thiagarajans@tmc.gov.in09846572399

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026