Viewing Study NCT06525779



Ignite Creation Date: 2024-10-26 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06525779
Status: COMPLETED
Last Update Posted: None
First Post: 2024-07-24

Brief Title: Comparison of Requirement of External Laryngeal Manipulation in Double Lumen Tube Insertion With McGrath Laryngoscope vs Macintosh Laryngoscope A Randomized Control Trial
Sponsor: None
Organization: None

Study Overview

Official Title: Comparison of Requirement of External Laryngeal Manipulation in Double Lumen Tube Insertion With McGrath Laryngoscope vs Macintosh Laryngoscope A Randomized Control Trial
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: For anatomical and physiological isolation of the lung a specialized endotracheal tube known as the double lumen tube DLT is used The introduction of DLT into anesthesia can be attributed to Carlens who brought forth the concept in 1949 Since then the structure of DLT has continuously evolved Simplistically speaking the double lumen tube is a co-axial tube ie it contains two tubes put together the tube with the shorter length stays in the trachea whereas the tube with the longer length enters the right or left main bronchus If the proximal or tracheal cuff is inflated air entry is permitted into both lungs However if the distal or the bronchial cuff is inflated ventilation is directed into either lung depending on which lumen has been clamped at the proximal end of the tube Conventionally the DLTs were made of red rubber and were reusable but now they have been replaced by disposable plastic tubes which make it easy to view any secretions or blood Also since the plastic makes for a thin wall it allows the lumen of the tube to be large enough to allow airflow with minimal resistance Larger lumens also allow passage of suction catheters and fiber-optic bronchoscope which serves the purpose of confirming correct position of the double lumen tube after placement Tracheal intubation with a DLT may be facilitated by maneuvers such as external laryngeal manipulation ELM It is a simple technique which has been used by anesthetists since many years to enable intubation Various types of video-laryngoscopes VL have been found to perform a crucial part in patients with difficult airways McGrath video-laryngoscope - a portable machine - provides a better laryngeal view compared to Macintosh laryngoscopy involving cases of intubation involving patients with normal or difficult airways Though the use of VL for DLT placement has been reported such studies have fallen short of producing the desired quality of evidence that is required to make a clear determination in favor of one method over the other It is suggested that more work is needed on this in order to create a wider more reliable data pool
Detailed Description: After approval from the hospitals institutional review board a prospective clinical study was conducted at Shaukat Khanum Memorial Cancer Hospital and Research Centre SKMCH RC Lahore from January 25 2021 to July 25 2021 Data was collected from 60 patients that fulfilled the inclusion criteria Features considered included patients demographic including age gender co-morbidities and American Society of Anesthesiologist physical status In addition mallampati score mouth opening and Wilson score of all patients was recorded as part of routine anesthesia airway assessment Patients being taken for study were randomly assigned to either of the two groups of 30 each that is all patients at odd numbers 1 3 7 9 etc was allocated to Group 1 McGrath laryngoscope whereas all patient at even numbers 2 6 8 10 etc was allocated to Group 2 Macintosh laryngoscope After explaining the procedure in detail and obtaining an informed consent in the presence of a witness patients were transferred to the operating room After standard induction of anesthesia tracheal intubation using either of the two laryngoscopes depending on group allocation McGrath laryngoscope or Macintosh laryngoscope was performed by a designated anesthesia consultant experienced in the use of double-lumen tubes The requirement of external laryngeal manipulation was recorded on a predesigned checklist

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None