Clinical trial NCT03934515: End-Tidal CO2 (etCO2) and pH in the Correct Naso-gastric Tube Placement
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Feeding Tube
Blood Gas Monitoring, Transcutaneous
pH
Keywords: naso-gastric tube, etCO2, pH
Lead sponsor: Clinica Luganese Moncucco
Sponsor class: OTHER
Collaborators: name: Ospedale Regionale Bellinzona e Valli
First posted: 2019-05-02
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: etCO2 level
timeFrame: 30-60 seconds
measure: pH
timeFrame: 30-60 seconds
Secondary outcomes:
measure: etCO2 level in chronic obstructive pulmonary disease (COPD) patients
timeFrame: 30-60 seconds
measure: pH in patients taking proton pump inhibitors (PPIs)
timeFrame: 30-60 seconds
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Clinica Luganese Moncucco
Study officials:
affiliation: Clinica Luganese Moncucco
name: Samuele Ceruti, MD
role: PRINCIPAL_INVESTIGATOR
References:
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