Manmohan Cardiothoracic Vascular and Transplant Centre
Kathmandu, Bagmati, Nepal
NCT Number: NCT07373171
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Kathmandu, Bagmati, Nepal
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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
Contact information is provided by the study sponsor or research team.
Tribhuvan University, Nepal
Other
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