免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / End-Tidal CO2 (etCO2) and pH in the Correct Naso-gastric Tube Placement (NGT)

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

Study Description
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).

Condition or disease Intervention/treatment
Gastric Feeding Tube Blood Gas Monitoring, Transcutaneous pH Other: etCO2 Other: pH

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : April 1, 2021
Estimated Study Completion Date : August 1, 2021
Arms 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 Name: 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 Name: Phase B

Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Samuele Ceruti, MD 0041 091 960 ext 8108 samuele.ceruti@moncucco.ch
Contact: Maira Biggiogero, PhD 0041 091 960 ext 8666 maira.biggiogero@moncucco.ch

Locations
Layout table for location information
Switzerland
Clinica Luganese Moncucco Recruiting
Lugano, Switzerland, 6900
Contact: Samuele Ceruti, MD    0041 091 960 ext 8108    samuele.ceruti@moncucco.ch   
Contact: Maira Biggiogero, PhD    0041 091 960 ext 8666    maira.biggiogero@moncucco.ch   
Sub-Investigator: Andrea Saporito, MD         
Sponsors and Collaborators
Clinica Luganese Moncucco
Ospedale Regionale Bellinzona e Valli
Investigators
Layout table for investigator information
Principal Investigator: Samuele Ceruti, MD Clinica Luganese Moncucco
Tracking Information
First Submitted Date April 26, 2019
First Posted Date May 2, 2019
Last Update Posted Date April 23, 2021
Actual Study Start Date November 1, 2020
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2020)
  • 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.
Original Primary Outcome Measures
 (submitted: April 30, 2019)
etCO2 level [ Time Frame: 30-60 seconds ]
To identify, for both groups of patients, the threshold value between the two populations of values that are found for etCO2.
Change History
Current Secondary Outcome Measures
 (submitted: March 5, 2020)
  • 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)
  • 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.
Original Secondary Outcome Measures
 (submitted: April 30, 2019)
etCO2 level in COPD patients [ Time Frame: 30-60 seconds ]
subanalysis for the threshold value in the group with COPD
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Gastric Feeding Tube
  • Blood Gas Monitoring, Transcutaneous
  • pH
Intervention
  • 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 Name: Group A
  • 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 Name: Phase B
Study Groups/Cohorts
  • 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.

    Intervention: 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.

    Intervention: Other: pH
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.
  • 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.
  • 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.
  • 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.
  • 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. Epub 2005 Sep 20.
  • 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.
  • 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. Review.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 5, 2020)
75
Original Estimated Enrollment
 (submitted: April 30, 2019)
50
Estimated Study Completion Date August 1, 2021
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Samuele Ceruti, MD 0041 091 960 ext 8108 samuele.ceruti@moncucco.ch
Contact: Maira Biggiogero, PhD 0041 091 960 ext 8666 maira.biggiogero@moncucco.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03934515
Other Study ID Numbers CLM_ICU_001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Samuele Ceruti, Clinica Luganese Moncucco
Study Sponsor Clinica Luganese Moncucco
Collaborators Ospedale Regionale Bellinzona e Valli
Investigators
Principal Investigator: Samuele Ceruti, MD Clinica Luganese Moncucco
PRS Account Clinica Luganese Moncucco
Verification Date April 2021