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Completed

NCT Number: NCT03934515

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Luganese Moncucco

Lugano, 6900, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Group A

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.

Other names: Phase B

Primary outcomes

  1. etCO2 level

    Time frame: 30-60 seconds

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

  2. 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.

Secondary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Clinica Luganese Moncucco

Other

Collaborators

  • Ospedale Regionale Bellinzona e Valli

Registry information

Official study title

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

Acronym: NGT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 2, 2019
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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