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

NCT03934515 | Completed

• 1 other identifier: CLM_ICU_001
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastric Feeding Tube; Blood Gas Monitoring, Transcutaneous; pH

Keywords

naso-gastric tube, etCO2, pH

Outcome Measures

Primary Outcomes (2)

• etCO2 level

  to find a threshold value of etCO2 collected when the NGT is well positioned in trachea

  30-60 seconds

• 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 Outcomes (2)

• etCO2 level in chronic obstructive pulmonary disease (COPD) patients

  30-60 seconds

• pH in patients taking proton pump inhibitors (PPIs)

  30-60 seconds

Study Arms (2)

Group A - etCO2

At the end of the anaesthesia , as usual, the secretions are aspirated with a suction tube of 18 Fr of caliber (diameter 6 mm). When the tube is inserted into the endotracheal tube, before proceeding with the aspiration of the secretions, a capnometer is attached to its outer end, measuring the etCO2 value for 10-15 seconds. At the end of the measurement, authors proceed with the aspiration of the secretions as usual. Authors then proceed with the laying of a NGT according to local protocols. Also in this case, once the NGT has been inserted, the etCO2 is measured at the end of the probe for 10-15 seconds. At the end of the measurement, the capnometer can be detached, as a standard procedure, and the NGT can be used as usual. 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 recorded at the endotracheal level and the one recorded at the oesophageal level.

Other: etCO2

Group B - pH

At the end of the anaesthesia , once the NGT is inserted, the pH is measured by aspirating the gastric contents and measuring on specific litmus paper the pH values, both at a distance of 25 cm from the mouth (oesophageal site) and at a distance of 40 cm (gastric site). 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 oesophageal level and a value at the gastric level.

Other: pH

Interventions

etCO2 OTHER

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.

Also known as: Group A

Group A - etCO2

pH OTHER

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.

Also known as: Phase B

Group B - pH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who required a NGT placement in Clinica Luganese Moncucco and in Regional Hospital of Bellinzona who will signed the Informed Consent Form

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Luganese Moncucco: lead
• Ospedale Regionale Bellinzona e Valli: collaborator

Study Sites (1)

Clinica Luganese Moncucco

Lugano, 6900, Switzerland

Location

Related Publications (10)

• 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. doi: 10.1177/0148607105029004305.

  PMID: 15961688 BACKGROUND

• 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.

  PMID: 22100480 BACKGROUND

• 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. doi: 10.1097/00000542-199907000-00022.

  PMID: 10422939 BACKGROUND

• 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. No abstract available.

  PMID: 21296259 BACKGROUND

• 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. doi: 10.1007/s00134-005-2791-1. Epub 2005 Sep 20.

  PMID: 16172849 BACKGROUND

• 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.

  PMID: 19626360 RESULT

• 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.2010.03.015.

  PMID: 20399427 RESULT

• 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.

  PMID: 21622643 RESULT

• 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: 10.1186/1757-7241-20-38.

  PMID: 22691418 RESULT

• Ceruti S, Dell'Era S, Ruggiero F, Bona G, Glotta A, Biggiogero M, Tasciotti E, Kronenberg C, Lollo G, Saporito A. Nasogastric tube in mechanical ventilated patients: ETCO2 and pH measuring to confirm correct placement. A pilot study. PLoS One. 2022 Jun 2;17(6):e0269024. doi: 10.1371/journal.pone.0269024. eCollection 2022.

  PMID: 35653380 DERIVED

Related Links

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

MeSH Terms

Interventions

Hydrogen-Ion Concentration

Intervention Hierarchy (Ancestors)

Chemical Phenomena

Study Officials

• Samuele Ceruti, MD

  Clinica Luganese Moncucco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 2, 2019
• Study Start: November 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)