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Not yet recruitingNCT07373171Updated Jan 28, 2026

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

An interventional study of Intubation of patients undergoing thoracic surgery with left sided double lumen tube in Lung Adenocarcinoma and Lung Abscess, sponsored by Tribhuvan University, Nepal. Not yet recruiting at 1 site in Nepal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Tribhuvan University, Nepal · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Adenocarcinoma
  • Lung Abscess
03

In context

Adenocarcinoma of Lung

418 studies on the registry are indexed under Adenocarcinoma of Lung; 79 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 293 interventional studies indexed under Adenocarcinoma of Lung.

Browse Adenocarcinoma of Lung studies →

Lead sponsor

Tribhuvan University, Nepal is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    35 Fr group

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

  • No intervention
    DLT size according to height

Interventions

  • DeviceIntubation 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

  2. 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.

    Time frame: Day 1

  3. 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

    Time frame: Day 2

07

Study locations

1 site
  • Manmohan Cardiothoracic Vascular and Transplant Centre
    Kathmandu, Bagmati, Nepal
08

References and documents

Individual participant data

Plan to share: Yes — Allocated group of participant, participant demographic, primary and secondary outcomes, data analysis and result will be shared after completion of the study.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07373171
Lead sponsor
Tribhuvan University, Nepal
Responsible party
Jog Adhikari (MD resident Doctor, Tribhuvan University, Nepal) — Principal investigator
First posted
Jan 28, 2026
Start date
Jan 2026 (estimated)
Primary completion
Mar 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Jan 28, 2026

Study contacts

Jog Adhikari, MBBS
Contact
adhikarijogbahadur@gmail.com
009779843233830

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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