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

October 4, 2021 updated by: Samuele Ceruti, Clinica Luganese Moncucco

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lugano, Switzerland, 6900
        • Clinica Luganese Moncucco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Group A
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
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.
Other Names:
  • Phase B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
etCO2 level
Time Frame: 30-60 seconds
to find a threshold value of etCO2 collected when the NGT is well positioned in trachea
30-60 seconds
pH
Time Frame: 30-60 seconds
to find a threshold value of pH collected when the NGT is positioned in the esophagus and in the stomach.
30-60 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
etCO2 level in chronic obstructive pulmonary disease (COPD) patients
Time Frame: 30-60 seconds
subanalysis for the threshold value in the group with chronic obstructive pulmonary disease (COPD)
30-60 seconds
pH in patients taking proton pump inhibitors (PPIs)
Time Frame: 30-60 seconds
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Luganese Moncucco

Collaborators

Ospedale Regionale Bellinzona e Valli

Investigators

  • Principal Investigator: Samuele Ceruti, MD, Clinica Luganese Moncucco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

April 26, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLM_ICU_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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