Gastric Feeding TubeNGTNCT03934515
End-Tidal CO2 (etCO2) and pH in the Correct Naso-gastric Tube Placement
An observational study of Gastric Feeding Tube and Blood Gas Monitoring, Transcutaneous, run by Clinica Luganese Moncucco at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Feeding Tube, Blood Gas Monitoring, Transcutaneous, pH
- What is being tested?
- etCO2 and pH
- How many people
- 85 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2020to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- etCO2, pH
- Keywords
- naso-gastric tube, etCO2, pH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etCO2Other
Also called Group A
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.
pHOther
Also called Phase B
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: pH |
What is being measured
The primary outcome is the main question the study is designed to answer.
etCO2 level
to find a threshold value of etCO2 collected when the NGT is well positioned in trachea
Measured: 30-60 seconds
pH
to find a threshold value of pH collected when the NGT is positioned in the esophagus and in the stomach.
Measured: 30-60 seconds
Secondary outcomes (2)
etCO2 level in chronic obstructive pulmonary disease (COPD) patients
subanalysis for the threshold value in the group with chronic obstructive pulmonary disease (COPD)
Measured: 30-60 seconds
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.
Measured: 30-60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Nov 2020
- Primary completion1 Apr 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gastric Feeding TubeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Luganese Moncucco
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Regionale Bellinzona e Valli
- Responsible party
- Principal investigator, Samuele Ceruti, Clinica Luganese Moncucco
- Investigators
- Samuele Ceruti, MD, Principal investigator, Clinica Luganese Moncucco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934515
- Sponsor's protocol ID
- CLM_ICU_001
- Acronym
- NGT
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2019
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15961688Nguyen 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.
PubMed 22100480Ozer 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.
PubMed 10422939Prasad 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.
PubMed 21296259Vigneau 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.
PubMed 16172849Chun 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.
PubMed 19626360Fernandez 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.
PubMed 20399427Gilbertson 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.
PubMed 21622643Kim 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.
PubMed 22691418Ceruti 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.
PubMed 35653380
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03934515
- Acronym / sponsor ID
- NGT / CLM_ICU_001
- Keywords
- naso-gastric tube, etCO2, pH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Clinica Luganese MoncuccoUniversity, hospital or other
- Collaborators
- Ospedale Regionale Bellinzona e Valli
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - etCO2 | – | Other: etCO2At 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. |
| Group B - pH | – | Other: pHAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etCO2Also: Group AAt 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 | Group A - etCO2 |
| pHAlso: Phase BAt 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 | Group B - pH |
Primary outcome
etCO2 level
Time frame: 30-60 seconds
to find a threshold value of etCO2 collected when the NGT is well positioned in trachea
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.
2 secondary outcomes
etCO2 level in chronic obstructive pulmonary disease (COPD) patients
Time frame: 30-60 seconds
pH in patients taking proton pump inhibitors (PPIs)
Time frame: 30-60 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 15961688Bercik 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.
- Background: PubMed 22100480Nguyen 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.
- Background: PubMed 10422939Ozer 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.
- Background: PubMed 21296259Prasad 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.
- Background: PubMed 16172849Vigneau 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.
- Results publication: PubMed 19626360Chun 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.
- Results publication: PubMed 20399427Fernandez 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.
- Results publication: PubMed 21622643Gilbertson 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.
- Results publication: PubMed 22691418Kim 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.
- Derived from this study: PubMed 35653380Ceruti 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.
- Principles for medical research involving human subjectsLink provided by the sponsor.
- Guideline for good clinical practiceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuele Ceruti, MD principal investigator
Clinica Luganese Moncucco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Feeding Tube and Blood Gas Monitoring, Transcutaneous, run by Clinica Luganese Moncucco at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
etCO2 level (time frame: 30-60 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934515, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.