End-Tidal CO2 (etCO2) and pH in the Correct Naso-gastric Tube Placement

pH Clinical Trial

— NGT  

Official title:

Tracheal etCO2 Level and Gastric pH Level Measurements During the Correct Naso-gastric Tube Placement in Unconscious Patients. A Physiological, Prospective, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934515
• Other study ID #: CLM_ICU_001
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2021
• Source: Clinica Luganese Moncucco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The laying of a naso-gastric tube is an extremely common event in intensive medicine; although standard naso-gastric tube laying is performed at the patient's bedside, this procedure is not without risk. Through the use of methods already used in the clinical field, of daily use, we want to identify the threshold value between tracheal and esophageal etCO2 (group A) and the threshold value between gastric and esophageal pH (group B).

Description:

Numerous methodologies have been evaluated to recognize the correct positioning of NGT at the gastric level, including different clinical techniques (such as gastric auscultation, aspiration of the NGT), ultrasound techniques, etc. Actually, the diagnostic gold standard is the thoraco-abdominal anterior-posterior radiography, which is considered the only non-invasive method capable to confirm the correct pose of the NGT at intra-diaphragmatic level. This method, however, even if it is non-invasive, requires the use of ionizing radiation (4 micro-Sievert (uSv) for radiography) which could be repeated multiple time for the same patient; NGT may need to be repositioned several times during the same hospital stay, increasing patient exposure to ionizing radiation and, potentially, also the health workers exposure.

The aim is to identify into the group A the threshold value between tracheal and esophageal etCO2 and into the group B the theshold value between gastric and esophageal pH.

Phase A: etCO2 measurement will be collected 1. after intubation, when the tube is inserted into the endotracheal tube, before proceeding with the aspiration of secretions and 2. once the NGT has been inserted, by a probe located at the end of the tube.

Phase B: pH measurement will be collected at the end of the procedure, once the NGT is inserted, at 1.a distance of 25 cm from the mouth (oesophageal site) and at 2. a distance of 40 cm (gastric site), aspirating the gastric contents and measuring on specific litmus paper.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult patients (> 18 years)

• Patients male and female

• Patients intubated by oro- or naso-tracheal way

• Post-induction curarized patients

• Fasting patients (from at least 6 hours)

Exclusion criteria:

• Patient refusal

• Patients with known bleeding diathesis / ongoing bleeding

• Patients at risk of bleeding (defined as thrombocytes <50 G/l, fibrinogen <1.0 g/l, international normalized ratio (INR) > 2.5, activated partial thromboplastin time (aPTT) > 70 sec)

• Patients with traumatic brain injury / Polytrauma

• Patients with esophagus-tracheal fistulas or malformations of the ear, nose, and throat (ENT) sphere

• Patients with current or previous radiotherapy of the ENT sphere

• Patients unable to give their informed consent due to language barriers

• Women who are pregnant

Related Conditions & MeSH terms

• Blood Gas Monitoring, Transcutaneous
• Gastric Feeding Tube
• pH

Intervention

Other:
• etCO2
At the end of the procedure, therefore, for each patient two values of etCO2 are acquired which will allow to obtain two "populations of values" of the etCO2: the values at the endotracheal level and the esophageal level values. The authors will find the "threshold value" of etCO2 collected when the NGT is well positioned in trachea. The study manager is not directly involved in the measurement and recording of etCO2 values.
• pH
At the end of the procedure, for each patient two values of pH are acquired which will allow to obtain two pH "value populations": a value at esophageal level and a value at the gastric level. The authors will find the "threshold value" of pH collected when the NGT is positioned in the esophagus and in the stomach. The study manager is not directly involved in the measurement and recording of pH values.

Locations

Country	Name	City	State
Switzerland	Clinica Luganese Moncucco	Lugano

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Luganese Moncucco	Ospedale Regionale Bellinzona e Valli

Country where clinical trial is conducted

Switzerland, 

References & Publications (9)

Bercik P, Schlageter V, Mauro M, Rawlinson J, Kucera P, Armstrong D. Noninvasive verification of nasogastric tube placement using a magnet-tracking system: a pilot study in healthy subjects. JPEN J Parenter Enteral Nutr. 2005 Jul-Aug;29(4):305-10. — View Citation

Chun DH, Kim NY, Shin YS, Kim SH. A randomized, clinical trial of frozen versus standard nasogastric tube placement. World J Surg. 2009 Sep;33(9):1789-92. doi: 10.1007/s00268-009-0144-x. — View Citation

Fernandez RS, Chau JP, Thompson DR, Griffiths R, Lo HS. Accuracy of biochemical markers for predicting nasogastric tube placement in adults--a systematic review of diagnostic studies. Int J Nurs Stud. 2010 Aug;47(8):1037-46. doi: 10.1016/j.ijnurstu.2010.0 — View Citation

Gilbertson HR, Rogers EJ, Ukoumunne OC. Determination of a practical pH cutoff level for reliable confirmation of nasogastric tube placement. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):540-4. doi: 10.1177/0148607110383285. Epub 2011 May 27. — View Citation

Kim HM, So BH, Jeong WJ, Choi SM, Park KN. The effectiveness of ultrasonography in verifying the placement of a nasogastric tube in patients with low consciousness at an emergency center. Scand J Trauma Resusc Emerg Med. 2012 Jun 12;20:38. doi: 10.1186/17 — View Citation

Nguyen L, Lewiss RE, Drew J, Saul T. A novel approach to confirming nasogastric tube placement in the ED. Am J Emerg Med. 2012 Oct;30(8):1662.e5-7. doi: 10.1016/j.ajem.2011.09.010. Epub 2011 Nov 17. — View Citation

Ozer S, Benumof JL. Oro- and nasogastric tube passage in intubated patients: fiberoptic description of where they go at the laryngeal level and how to make them enter the esophagus. Anesthesiology. 1999 Jul;91(1):137-43. — View Citation

Prasad G, Garg R. The 'bubble technique': an innovative technique for confirming correct nasogastric tube placement. J Clin Anesth. 2011 Feb;23(1):84-5. doi: 10.1016/j.jclinane.2010.03.006. — View Citation

Vigneau C, Baudel JL, Guidet B, Offenstadt G, Maury E. Sonography as an alternative to radiography for nasogastric feeding tube location. Intensive Care Med. 2005 Nov;31(11):1570-2. Epub 2005 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	etCO2 level	to find a threshold value of etCO2 collected when the NGT is well positioned in trachea	30-60 seconds
Primary	pH	to find a threshold value of pH collected when the NGT is positioned in the esophagus and in the stomach.	30-60 seconds
Secondary	etCO2 level in chronic obstructive pulmonary disease (COPD) patients	subanalysis for the threshold value in the group with chronic obstructive pulmonary disease (COPD)	30-60 seconds
Secondary	pH in patients taking proton pump inhibitors (PPIs)	identify patients taking proton pump inhibitors (PPIs) and perform a sub-subanalysis for the threshold value in the group with already diagnosed gastro-esophageal reflux disease.	30-60 seconds

External Links

•   Definitions and standards on clinical safety information
•   Federal law concerning research on human subjects
•   Guideline for good clinical practice
•   Ordinance on Clinical Trials in Human Research
•   Principles for medical research involving human subjects