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

January 22, 2026 updated by: Jog Adhikari, Tribhuvan University, Nepal
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.

Study Overview

Status

Status

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Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • Nepal
    • Bagmati
      • Kathmandu, Bagmati, Nepal
        • Manmohan Cardiothoracic Vascular and Transplant Centre
        • Contact:

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 35 Fr group
Device: Intubation of patients undergoing thoracic surgery with left sided double lumen tube
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.
No Intervention: DLT size according to height

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ease of intubation using a 35 Fr DLT
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 2

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tribhuvan University, Nepal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 258/0821083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Allocated group of participant, participant demographic, primary and secondary outcomes, data analysis and result will be shared after completion of the study.

IPD Sharing Time Frame

IPD will be shared after completion of the study and will be available for 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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