search
Back to results

A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques

Primary Purpose

Surgery, Hypoventilation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arterial blood draw
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Surgery focused on measuring Hysteroscopic surgery, Hypoventilation, Co2, Transcutaneous Co2 Monitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age>18 years of age
  • Sex: Non-pregnant, Female
  • ASA PS: I, II
  • Surgery: Elective Hysteroscopy surgery
  • Consent: Obtained

Exclusion Criteria:

  • Age < 18 years old
  • Patients who refuses participation
  • History of lung disease
  • History of Obstructive sleep apnea

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

All participants, one arterial blood draw

Outcomes

Primary Outcome Measures

TcCo2 vs PACo2 Difference
Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2

Secondary Outcome Measures

Full Information

First Posted
August 5, 2009
Last Updated
June 25, 2014
Sponsor
Northwestern University
search

1. Study Identification

Unique Protocol Identification Number
NCT00954733
Brief Title
A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques
Official Title
A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The estimation of the partial pressure of carbon dioxide (PCO2) in the arterial blood is used to judge the adequacy of ventilation during spontaneous and controlled ventilation. Although the gold standard for monitoring PCO2 remains arterial blood gas sampling, this requires an invasive procedure and provides only an intermittent estimate of what is frequently a continuously changing value. The solution to this problem has been the development and validation of accurate noninvasive monitoring techniques which provide a continuous intraoperative estimate of PCO2.The most commonly used noninvasive technique to monitor PCO2 is measurement of the end tidal CO2 (PECO2) . However, sampling errors and patient -related issues such as ventilation-perfusion mismatch, patient positioning or decreases in pulmonary blood flow may influence the accuracy of PECO2 monitoring (1-3). Nasal capnography has been proved to be an accurate monitor during the post-operative period (4) but its ability to accurately detect hypoventilation associated with deep sedation has not been studied. According to the American Society of Anesthesiologist standards for basic monitoring, continuous capnography is required for all patients undergoing general anesthesia but it is optional for MAC/sedation cases. The need for CO2 monitoring has been studied by other medical specialties that use procedural sedation, including gastroenterology (12) and emergency medicine (13, 14) and many specialties now recommend capnography as a standard monitor. Patients receiving supplemental oxygen may experience significant persistent hypoventilation leading to progressive hypercarbia and acidosis which may go undetected for a significant time interval since the routinely monitored SpO2 may be maintained within normal range. A recent study has shown that despite the fact that end tidal CO2 is reliable in detecting apnea , increasing oxygen flow rates decrease the amplitude of measured CO2, probably via dilution, making the quantitative value less reliable as an assessment of adequacy of ventilation (15). Furthermore, during hypoventilation there is reduced alveolar ventilation and the end tidal CO2 is not a true reflection of arterial CO2. Transcutaneous measurement of PCO2(PtcCO2) is a non-invasive method of measuring PCO2 that has been used much less frequently due to technical difficulties with earlier transcutaneous electrodes. Preliminary studies of the reliability of the current PtcCO2 electrodes (TOSCA, Linde Medical Sensors, and Basel, Switzerland) have shown good correlation of arterial and transcutaneous measurements in both adult volunteers and anesthetized subjects (5). PtcCO2 is measured with a sensor attached by a low pressure clip to an earlobe. The sensor probe heats the earlobe to 42 degrees Celsius to enhance blood flow. The current sensors have also been evaluated in anesthetized children (7, 8), anesthetized adults (9, 10) and critically ill neonates (11) and all these studies revealed a good correlation between PtCO2 and PaCO2.
Detailed Description
A group of _40 patients scheduled to undergo Hysteroscopy surgery with deep sedation will be studied. Standard monitors will be utilized. Additionally a transcutaneous CO2 electrode will be attached to the ear lobe and a BIS monitor will be applied to the forehead. The anesthetic management will be left to the discretion of the anesthesia provider (Anesthesia resident or CRNA, under the supervision of a faculty attending anesthesiologist).All patients will receive supplemental oxygen at 3L/ minute via nasal cannula, to maintain oxygen saturation greater than 90%. Both the end tidal CO2 (ETCO2) and transcutaneous CO2 (TcCO2) (Linde Medical Sensors, Basel , Switzerland ) will be calibrated before use, according to the manufacturer's instruction.. The anesthesia provider will be blinded to the TcCO2 monitor but will have access to the ETCO2 values. The ETCO2 and TcCO2 values will be recorded simultaneously by an independent observer. One arterial blood samples will be collected from each subject for measurement of PaCO2 at a deep level of sedation defined by a modified Ramsey score greater or equal to 5 (1= anxious/agitated/restless; 2= cooperative/oriented/tranquil; 3= drowsy/responds to commands only; 4= brisk response to shaking/loud sound; 5= sluggish response to shaking/loud sound; 6= no response) The ETCO2 and .TcCO2 will be recorded throughout the time of obtaining the blood sample every 15 seconds and the mean value will be used for comparison. Hypoventilation will be defined as a PaCO2 level greater than 45mmHg. Sedation score (OASS) will be recorded on admission to recovery area. Time to meet discharge criteria will be recorded. The experimental procedures: ABG draw, ETCO2 monitor placement on the ear, 2 Ramey scale assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Hypoventilation
Keywords
Hysteroscopic surgery, Hypoventilation, Co2, Transcutaneous Co2 Monitor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All participants
Arm Type
Experimental
Arm Description
All participants, one arterial blood draw
Intervention Type
Other
Intervention Name(s)
Arterial blood draw
Intervention Description
One arterial blood draw
Primary Outcome Measure Information:
Title
TcCo2 vs PACo2 Difference
Description
Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2
Time Frame
1 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age>18 years of age Sex: Non-pregnant, Female ASA PS: I, II Surgery: Elective Hysteroscopy surgery Consent: Obtained Exclusion Criteria: Age < 18 years old Patients who refuses participation History of lung disease History of Obstructive sleep apnea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert McCarthy, PharmD
Organizational Affiliation
Northwestern University
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6787952
Citation
Whitesell R, Asiddao C, Gollman D, Jablonski J. Relationship between arterial and peak expired carbon dioxide pressure during anesthesia and factors influencing the difference. Anesth Analg. 1981 Jul;60(7):508-12.
Results Reference
background
PubMed Identifier
3117500
Citation
Yamanaka MK, Sue DY. Comparison of arterial-end-tidal PCO2 difference and dead space/tidal volume ratio in respiratory failure. Chest. 1987 Nov;92(5):832-5. doi: 10.1378/chest.92.5.832.
Results Reference
background
PubMed Identifier
9895064
Citation
Grenier B, Verchere E, Mesli A, Dubreuil M, Siao D, Vandendriessche M, Cales J, Maurette P. Capnography monitoring during neurosurgery: reliability in relation to various intraoperative positions. Anesth Analg. 1999 Jan;88(1):43-8. doi: 10.1097/00000539-199901000-00009.
Results Reference
background

Learn more about this trial

A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques

We'll reach out to this number within 24 hrs