Evaluation of Different Sizes of Left-Sided Double-Lumen Tubes for Thoracic Surgery in a Tertiary Level Teaching Hospital

NCT07373171 | Not Yet Recruiting DMC

• 1 other identifier: 258/0821083
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Double lumen tubes (DLT) have become standard of care for one lung ventilation in thoracic and esophageal surgeries. Selection of accurate size of DLT is important to achieve proper one lung ventilation, prevent trauma to airway, easy intubation, prevention of displacement of DLT and adequate oxygenation intraoperatively. There are no definitive guidelines to select the correct size of DLT. The aim of this study is to observe if there is any difference in the number of intubation attempts, intraoperative oxygenation and postoperative sore throat while using 35 Fr DLT size and other DLT size. The research will be conducted between Ashoj 1st 2082 to Chaitra 30 2082 at Manmohan Cardiothoracic Vascular and Transplant Center(MCVTC). Fifty patients aged more than eighteen years undergoing thoracic surgery requiring One Lung Ventilation(OLV) with left sided DLT will be selected for the study. Participants will be randomly assigned to 35 Fr DLT size group or DLT size group according to the height. Patients in both the groups will be given the samepreoperative care, intraoperative care and postoperative care. Besides patient's demography, diagnosis and operative procedure; number of intubation attempts, modified Cromack-Lehane(CL) grade, size of DLT, intraoperative oxygen saturation SpO₂ and postoperative sore throat on day of surgery and first postoperative day will be recorded. Statistical analysis will be done using t- test for independent variable, confidence interval for outcome of sore throat, significance of difference for number of male and female; rates, risk ratio and odds ratio will be calculated using 2x2 contingency table. P ≤ 0.05 will be considered statistically significant. Our expected outcome is 35 Fr DLT are easier to intubate, does not affect intraoperative oxygenation and decrease the incidence of postoperative sore throat.

Conditions

Lung Adenocarcinoma; Lung Abscess

Outcome Measures

Primary Outcomes (3)

• Ease of intubation using a 35 Fr DLT

  Ease of intubation is assessed using "number of intubation attempt and "Cormack-Lehane grade" that will be determined by anaesthesia provider who is intubating. The number of intubation attempt is the tube pass attempt during intubation and Cormack-Lehane grade is the percentage of vocal cord structure visualized during direct laryngoscopy. Number of intubation attempt and cormack-Lehane grading will be recorded in the proforma of the study.

  Day 1

• Difference in intraoperative oxygenation between 35 Fr and different sizes of DLT

  The percentage of oxygen saturation( SpO2 %) will be recorded at 5 minutes and 10 minutes after one lung ventilation from the ventilator monitor attached to the patient in the operation room. The percentage of oxygen saturation will be recorded in the study proforma and later compared between the groups.

  Day 1

• Postoperative sore throat

  Postoperative sore throat will be assessed using a yes/no question asked by an attending nurse in the post operative ward within 24 hours of postoperative period. If the patient has sore throat then it will be graded. The question and grade will be as follow Do you have a sore throat: (yes/no) if the answer is yes then graded as 0 = no sore throat 1. = mild sore throat (complains of sore throat only on asking) 2. = moderate sore throat (complains of sore throat on his/her own) 3= severe sore throat (change of voice or hoarseness, associated with throat pain The answer and grade will be recorded and later analysed between the groups

  Day 2

Study Arms (2)

35 Fr group

EXPERIMENTAL

Device: Intubation of patients undergoing thoracic surgery with left sided double lumen tube

DLT size according to height

NO INTERVENTION

Interventions

Intubation of patients undergoing thoracic surgery with left sided double lumen tube DEVICE

During the intervention Integrity of the tracheal and bronchial cuffs will be checked first. Lubrication of the outside of the 35 Fr DLT will be done using 2.5% lidocaine jelly and intubating stylet will be inserted (can be preshaped to aid placement of the DLT). Direct laryngoscopy will be done to visualize the glottis. DLT will be advanced till the endobronchial cuff is passed beyond the vocal cords and then the stylet is removed. DLT will be rotated 90 anticlockwise and the tracheal cuff is inserted beyond the glottis until resistance is encountered.

35 Fr group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years or older undergoing thoracic surgery requiring OLV with placement of a left-sided DLT

You may not qualify if:

• Patient refusal
• Need for rapid sequence intubation (RSI) due to increased aspiration risk
• Anticipated difficult intubation
• Emergency surgery
• Patient already intubated with a single-lumen ET tube
• DLT tube change to single lumen tube at the end and shifted with ETT in situ

Sponsors & Collaborators

• Tribhuvan University, Nepal: lead

Study Sites (1)

Manmohan Cardiothoracic Vascular and Transplant Centre

Kathmandu, Bagmati, Nepal

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Lung Abscess

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Respiratory Tract Infections; Infections; Abscess; Suppuration; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jog Adhikari, MBBS

CONTACT

009779843233830; adhikarijogbahadur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD resident Doctor

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 28, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD will be shared after completion of the study and will be available for 12 months.

Locations

NE (1)