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Clinical Trials/CTRI/2022/05/042859
CTRI/2022/05/042859CompletedNot Applicable

Positive Predictive Value of the Presence of Endotracheal(ETT) cuff ballotability above the Suprasternal notch in diagnosing the Correct positioning of ETT(PRESeNCE)-A prospective Observational study

PGIMER1 site in 1 country76 target enrollmentStarted: January 6, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
PGIMER
Enrollment
76
Locations
1
Primary Endpoint
To determine whether the Endotracheal tube(ETT) cuff ballotability over the suprasternal notch accurately predicts the correct placement of ETT.

Study Overview

Brief Summary

Endotracheal intubation is one of the most common procedures used by anesthesiologists, intensivists and emergency personnel. But it can be associated with complications, such as carinal impingement or endobronchial intubation, which leads to increased incidence of barotrauma, contralateral lung collapse, or both, which result in hypoxemia and hemodynamic instability.

Three types of malposition can occur during intubation: one outside the trachea (esophageal), and two within the trachea: too shallow (hypopharyngeal/transglottic cuff), or too deep (endobronchial).

The various other methods for determining Endotracheal tube(ETT) placement are bilateral chest auscultation of equal air entry, chest X ray, fiberoptic bronchoscopy, capnography. However, these techniques are quite limited in actual clinical practice.

Ballotability of the ETT cuff over the anterior part of trachea above the supersternal space of Burns, could be a novel technique to confirm the proper ETT position.

Hence considering the simplicity of this test and its bedside/point of care utility, we

propose to investigate this method of cuff ballotment to verify the correct ETT

position and to explore its sensitivity, specificity, positive and negative predictive

value when compared with the gold standard of cervicothoracic Xray.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients who are undergoing any procedure in Digital Subtraction Angiography(DSA) suite under General Anesthesia.
  • •BMI< 30 kg/m2.

Exclusion Criteria

  • •Obesity Cervical collar in place Presence of mass in front of neck Previous history of radiation to neck Patient refusal to study Inability to visualise the Endotracheal tube cuff in x ray/ fluoroscopy.

Outcomes

Primary Outcomes

To determine whether the Endotracheal tube(ETT) cuff ballotability over the suprasternal notch accurately predicts the correct placement of ETT.

Time Frame: single time, with the data collected after the induction of General Anesthesia in all subjects.

Secondary Outcomes

  • To find the Positive Value of the Presence of endotracheal tube cuff ballotability above the Suprasternal notch for correct positioning of the ETT.(1)
  • To find the sensitivity and specificity of cuff ballotability for correct positioning of ETT.(Single time, done with the data collected after induction of general anesthesia in patients.)

Investigators

Sponsor
PGIMER
Sponsor Class
Research institution

Study Sites (1)

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