Studies
| Study First Submitted Date | 2022-06-21 |
| Study First Posted Date | 2022-06-30 |
| Last Update Posted Date | 2022-06-30 |
| Start Month Year | July 1, 2022 |
| Primary Completion Month Year | December 31, 2022 |
| Verification Month Year | June 2022 |
| Verification Date | 2022-06-30 |
| Last Update Posted Date | 2022-06-30 |
Detailed Descriptions
| Sequence: | 20794444 |
| Description | The trachea is a dynamic organ and its length varies by various static and dynamic factors leading to changing the tracheal length and variable endotracheal tube tip to carina (Ti-Ca) distance. Hence, upholding optimal Ti-Ca distance during changing tracheal length is of utmost importance to prevent complications associated with endotracheal tube (ETT) mal-positioning. When the length of ETT, which is to be inserted inside the trachea, is calculated as per an individual's tracheal morphometric dimensions, the appropriate depth of placement could be achieved and tube malpositioning can be prevented. In the topographical landmark technique, an individual tracheal length is estimated by measuring the various distance from mid-thyroid level (corresponds to vocal cords) to manubriosternal joint (corresponds to carina) in the sagittal plane. After estimating the tracheal length, tip to carina distance of 3cm was deducted from the estimated length of the trachea to provide the distance of the endotracheal tube to be kept beyond the vocal cords. Hence, the investigators planned this study to find the "utility and reliability" of the topographical landmark technique compared to the conventional intubation guide mark technique in providing the appropriate depth of endotracheal tube placement. |
Facilities
| Sequence: | 200753954 |
| Name | Amit |
| City | Rohini |
| State | Delhi |
| Zip | 110085 |
| Country | India |
Facility Contacts
| Sequence: | 28212714 |
| Facility Id | 200753954 |
| Contact Type | primary |
| Name | Amit Kr Mittal, MD |
| [email protected] | |
| Phone | 09717611416 |
Conditions
| Sequence: | 52358282 | Sequence: | 52358283 |
| Name | Intubation, Intratracheal | Name | Anatomic Landmarks |
| Downcase Name | intubation, intratracheal | Downcase Name | anatomic landmarks |
Id Information
| Sequence: | 40292576 |
| Id Source | org_study_id |
| Id Value | RES/SCM/35/2019/68 |
Countries
| Sequence: | 42715653 |
| Name | India |
| Removed | False |
Design Groups
| Sequence: | 55801178 | Sequence: | 55801179 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | Topographical landmark technique | Title | Intubation guide mark technique |
| Description | Surface anatomic landmarks of an individual's trachea will be measured from the mid-thyroid level (corresponds to vocal cords) to manubriosternal joint (corresponds to carina) in the sagittal plane to estimate tracheal length. Three centimeters will be deducted from the estimated tracheal length to provide the length of the endotracheal tube from the tube tip to be inserted inside the trachea. | Description | Already established and commonly practiced technique, in this technique, the guide mark present above the proximal end of the endotracheal tube cuff will be placed just beyond the vocal cords. |
Interventions
| Sequence: | 52669193 | Sequence: | 52669194 |
| Intervention Type | Device | Intervention Type | Device |
| Name | Topographical landmark technique of endotracheal tube placement | Name | Intubation guide mark technique of endotracheal tube placement |
| Description | An endotracheal tube will be placed inside the trachea after measuring the individual's estimated tracheal dimensions. | Description | An endotracheal tube will be placed in this group by using the intubation guide mark. |
Keywords
| Sequence: | 80125819 | Sequence: | 80125820 |
| Name | Endotracheal tube placement | Name | Topographical landmarks of trachea |
| Downcase Name | endotracheal tube placement | Downcase Name | topographical landmarks of trachea |
Design Outcomes
| Sequence: | 178069503 |
| Outcome Type | primary |
| Measure | Endotracheal tube position inside the trachea |
| Time Frame | through study completion approximately at six months |
| Description | Tip to carina distance will be measured by fiber optic bronchoscopy to classify the optimal or suboptimal tube placements in both groups |
Sponsors
| Sequence: | 48493301 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Rajiv Gandhi Cancer Institute & Research Center, India |
Overall Officials
| Sequence: | 29384261 |
| Role | Principal Investigator |
| Name | Amit K Mittal, M.D |
| Affiliation | Senior Consultant, Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research centre |
Central Contacts
| Sequence: | 12056233 | Sequence: | 12056234 |
| Contact Type | primary | Contact Type | backup |
| Name | Amit K Mittal, M.D | Name | Anil K Patel, DNB |
| Phone | 09717611416 | Phone | 09781364051 |
| [email protected] | [email protected] | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68404392 | Sequence: | 68404393 |
| Design Group Id | 55801178 | Design Group Id | 55801179 |
| Intervention Id | 52669193 | Intervention Id | 52669194 |
Eligibilities
| Sequence: | 30873193 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 75 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: • Age group of 18-75 years ASA physical status I-III patients Oral intubation for general anesthesia Exclusion Criteria: • Patient with upper airway fibrosis Tracheal stenosis or tracheal surgeries Previous head and neck surgeries Contracture neck or irradiated neck Large neck swelling distorting or deviating the trachea Laryngeal or tracheal tumor Intubations requiring flexo-metallic tubes Patient refusal |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254043321 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Maximum Age Num | 75 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
Designs
| Sequence: | 30618987 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Prevention |
| Time Perspective | |
| Masking | Double |
| Masking Description | The primary investigator will provide the information regarding the portion of endotracheal to be kept below the vocal cords to the care provider after measuring the dimensions of the trachea topographically. After tube placement, the tube tip to carina distance will be measured in both topographical and intubation guide mark technique. |
| Intervention Model Description | All enrolled patients will be intubated by either topographical landmarks of individual tracheal dimensions or by the conventional intubation guide method. |
| Subject Masked | True |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 28985514 |
| Responsible Party Type | Principal Investigator |
| Name | Dr. Amit Kumar Mittal |
| Title | Principal Investigator |
| Affiliation | Rajiv Gandhi Cancer Institute & Research Center, India |