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

T

Tribhuvan University (TU)

Status

Not yet enrolling

Conditions

Lung Abscess
Lung Adenocarcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07373171
258/0821083

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

35 Fr group
Experimental group
Treatment:
Device: Intubation of patients undergoing thoracic surgery with left sided double lumen tube
DLT size according to height
No Intervention group

Trial contacts and locations

1

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Central trial contact

Jog Adhikari, MBBS

Data sourced from clinicaltrials.gov

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