A Prospective, Randomized Trial Comparing the Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients With High Risk of Obstructive Sleep Apnea Undergoing Colonoscopy
Phase: NA
Conditions: Desaturation of Blood, Colonoscopy
Sponsor: University of Texas Southwestern Medical Center

 
 
 
 
A Prospective, Randomized Trial Comparing the Use 
of High Flow Nasal Cannula, Standard Face Mask and 
Standard Nasal Cannula in Morbidly Obese Patients 
with High Risk of Obstructive Sleep Apnea 
Undergoing Colonoscopy 
 
NCT03479905 
 
 
Research Protocol 
Document Date 10-12-2020 
 
 

 
STU102017-005, Riccio, FormA-ResearchProtocol, Mod_12, 10-12-20 
 
Page 1 of 8; Protocol Version-2 
 
A Prospective, Randomized Trial Comparing the Use of High Flow Nasal Cannula, Standard 
Face Mask and Standard Nasal Cannula in Morbidly Obese Patients with High Risk of 
Obstructive Sleep Apnea Undergoing Colonoscopy  
 
Institution/Funding Source:  University of Texas Southwestern, Dallas, TX; 
 
 
 
 
  Departments of Anesthesiology and Pain Management 
 
Principal Investigator: Christina Riccio, M.D. 
 
 
1. Introduction and Purpose: 
It is standard practice in the United States and many parts of world to perform Gastrointestinal 
(GI) endoscopy with the patient under deep intravenous sedation (1). Obesity is accepted as a 
patient specific risk factor for hypoxic events during procedural sedation for GI endoscopic 
procedures. The obese population has a higher prevalence of obstructive sleep apnea (OSA), which 
is characterized by repeated obstruction of the upper airway, and leads to apnea and desaturation. 
This prospective, randomized study was designed to compare the effectiveness of the high flow 
nasal cannula, standard nasal cannula and standard face mask in morbidly obese patients with a 
high risk of sleep apnea, (BMI  40, STOPBANG 5) receiving deep intravenous sedation during 
colonoscopies. This study will assess which method leads to a lower incidence of intraoperative 
desaturation events compared to the current standard of care. 
 
Hypothesis 1- The High Flow Nasal Cannula (HFNC) group will have a significantly lower 
incidence of desaturation episodes (SpO2 <90) than both the standard nasal cannula group and 
face mask group during procedural sedation for colonoscopies. 
 
Primary objective: To compare the rates of incidence and frequency of desaturation episodes 
during procedural sedation in morbidly obese subjects with high likelihood of OSA undergoing 
colonoscopies.  
 
Hypothesis 2- The HFNC group will have a significantly lower frequency of desaturation episodes 
(SpO2 <90) than both the face mask and standard nasal cannula groups during procedural sedation 
for colonoscopies. 
 
Secondary objective 1: To compare the number of interventions made by the anesthesia providers 
required to treat desaturation events during procedural sedation in morbidly obese subjects with a 
high likelihood of OSA undergoing colonoscopies.  
 
Hypothesis 3- The HFNC group will require fewer interventions to treat hypoxic events than the 
standard nasal cannula and face mask groups during procedural sedation for colonoscopies. 
 
Secondary objective 2:  To determine the frequency of desaturation episodes and sedation-related 
adverse events during procedural sedation in morbidly obese subjects with high likelihood of OSA. 
 
Hypothesis 4- Use of HFNC would decrease sedation-related adverse events in morbidly obese 
subjects with a high likelihood of OSA.  

 
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2. Background: 
The prevalence of morbid obesity is increasing worldwide. As the severity of obesity increases, 
the incidence of diagnosed obstructive sleep apnea also rises.  Studies have shown an incidence of 
sleep apnea as high as 64% in patients with a body mass index (BMI) over 40 and 100% in patients 
with a BMI greater than 60 (2).  Patients with OSA have been shown to have significant 
desaturations under intravenous sedation due to airway narrowing and obstruction. Several studies 
have also shown that morbidly obese subjects, independent of a diagnosis of OSA, run a higher 
perioperative risk of adverse airway events, including hypoxia. Quadeer et al found a 51% overall 
incidence of desaturation below 90% in a prospective observational study with 79 patients 
undergoing endoscopy under “conscious sedation.” They also found a significant difference in the 
frequency of desaturation events between obese (BMI > 30) and non-obese patients (3). Many 
morbidly obese subjects present to our institution for GI procedures under deep sedation.  Data 
collected from our institution over the last six months revealed a 50% incidence of desaturation 
below 90% during colonoscopies under deep IV sedation in both the standard nasal cannula and 
HFNC at 40% FiO2 groups. Providing anesthesia for this patient population is challenging and 
requires careful titration of drugs and superb airway management skills.   
 
The current standard of care for oxygen delivery in this setting is a Salter nasal cannula. Patel et 
al have been working with a transnasal high flow device (THRIVE) and have shown it to increase 
apnea times in patients with difficult airways post induction of general anesthesia (4). These 
patients received neuromuscular blockade and made no respiratory effort, however, the patency of 
their airway was maintained with a manual jaw thrust by anesthesia providers. They concluded 
that the device combines the benefits of apneic oxygenation with continuous positive airway 
pressure and gaseous exchange occurs through flow-dependent dead space flushing (5). 
 
Humidified high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing 
from 21% to 100% FiO2 delivery and generates up to 60 L/min flow rates (6,7). The gas is heated 
(35 to 40 degree Celsius) and humidified through an active heated humidifier and delivered via a 
single limb heated inspiratory circuit (to avoid heat loss and condensation) to the subject through 
a large diameter nasal cannula (8, 9). Theoretically, HFNC offers significant advantages in 
oxygenation and ventilation over conventional methods (9). Constant high flow oxygen delivery 
provides steady inspired oxygen fraction (FiO2) and decreases oxygen dilution (10). It also washes 
out physiologic dead space and generates positive end expiration pressure (PEEP) that augments 
ventilation (10, 11). In the current narrative review, Sotello et al. summarized factors explained 
the improvement in respiratory parameters by using HFNC (12).  (1) Washout of the 
nasopharyngeal dead space; (2) reduction in inspiratory resistance associated with gas flow 
through the nasopharynx; (3) improvement in respiratory mechanical parameters associated with 
gas temperature and state of humidification; (4) reduction in metabolic work associated with gas 
conditioning; (5) provision of mild distending pressure. 
 
Some studies have demonstrated a positive effect of HFNC on the apnea-hypopnea index (AHI) 
showing that use of HFNC could decrease hypoxic episodes in subjects with repetitive upper 
airway obstruction such as obstructive sleep apnea.  The STOP-BANG questionnaire (SB) has 
been used successfully to screen patients undergoing therapeutic endoscopic procedures at higher 
risk for sedation-related adverse events (13). Mehta et al (14) evaluated the prevalence of 

 
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undiagnosed OSA at their endoscopy center and the relationship between a positive SB result and 
sedation-related adverse events. They found that 48.5% (118/243) of patients were SB+ and 
exhibited a higher level of potentially adverse medical conditions, with 66.3% (161/243) being 
classified with an SB score of 3.  
 
We are hypothesizing that the HFNC at a FiO2 of 100% at 60 L/min will help maintain a patent 
airway and improve gaseous exchange in morbidly obese (BMI 40) patients with SB scores 5 
undergoing deep sedation for colonoscopies and will result in a significant decrease in 
intraoperative desaturation events, thus improving morbidity and overall safety for this population. 
 
3. Concise Summary of Project:  
The study population for this randomized prospective clinical trial will consist of male and female 
subjects, between the ages of 18-80, with a BMI of 40 or greater and a STOPBANG score 5 
undergoing colonoscopies.  Consent will be obtained by anesthesia providers involved in the study. 
OSA screening questionnaire (STOPBANG) will be completed during review of the patient’s 
history and physical exam. Subjects will then be randomized in a stratified fashion to either the 
HFNC (Comfort Flo System) group, standard face mask group or the Salter cannula group. Then 
subjects will be brought into the procedure room and placed on all standard ASA monitors (BP 
cuff, EKG, pulse oximetry). Oxygen saturation will be measured at baseline (prior to the 
administration of any propofol or supplemental oxygen) and then continuously during procedural 
sedation.    
 
HFNC group: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% 
and titrated up to 60L/min depending on patient tolerance.  60 L/min is the max flow rate and will 
be used as tolerated for maximum benefit.  
 
Research intervention: The Comfort Flo system (Teleflex Medical, Research Triangle Park, NC, 
USA) will be used for high flow nasal cannula during colonoscopy.  The Comfort Flo System has 
an air-O2 blender setting and a FiO2 analyzer to confirm FiO2 delivered to the patient.  
 
Control groups:  
A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to 
the patient at this rate has been shown to be equal to 36% (15).  
 
Face mask group: A standard face mask will be used at 8L/minute during the colonoscopy.  The 
FiO2 delivered to the patient at this rate has been shown to be equal to 60% (16). 
 
The cannulas will be placed on the patients 5 minutes prior to the start of the anesthetic. All patients 
will receive a similar intravenous anesthetic with a propofol infusion titrated to a Richmond 
Agitation-Sedation Scale (RASS) score of 3-4. A lidocaine bolus of up to 100 mg can be used 
prior to the start of the propofol infusion for initial tolerance of the drug.  
 
Patient saturation is recorded every minute during the anesthetic on the electronic medical record 
and is available for review. The frequency of all measurements at or below 90% will be recorded 
by the Electronic Medical Record (EMR). The anesthesia providers intervene when the patient’s 
saturation falls below 90%, by either manually performing a jaw thrust, placing a nasal or oral 

 
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airway, bag mask ventilation, increasing the patients FiO2 or decreasing the rate/ pausing the 
propofol infusion or endotracheal intubation. They will be instructed to write a quick note at the 
time of intervention in the EMR reporting the lowest saturation witnessed and describing their 
maneuver. Duration of the study will be the length of the procedure through discharge from the 
Postoperative Anesthesia Care Unit (PACU). 
 
Outcome Measures: 
• Lowest recorded oxygen saturation 
• The frequency of desaturation episodes (SpO2 <90%)  
• Total dose of propofol for sedation during colonoscopy 
• Anesthesiologist intervention (intubation, airway repositioning, chin lift) 
• Type of airway used (oral airway, nasal airway, bag mask ventilation, suctioning) 
• Premature termination of procedure 
• Unplanned hospital admission 
 
4. Study Procedures: 
• OSA screening with the SB questionnaire: SB is made up of 8 yes or no questions (14). High 
risk of obstructive sleep apnea if yes to ≥5 questions; low risk of obstructive sleep apnea: yes 
to <5 questions. 
• Randomizations to the high flow nasal cannula group, the face mask group or the Salter cannula 
group. Subjects will be randomized in a 1:1:1 ratio according to a computer generated 
randomization list provided by the study statistician. 
• All standard monitoring (BP, EKG, and pulse oximeter) will be placed on all patients in the 
procedure room.  Supplemental oxygen will be placed on the patients 5 minutes prior to the 
start of the anesthetic and set to rate of 4L/min for standard nasal cannula, 8L/min for the face 
mask group and 100% FiO2 up to 60 L/min for the HFNC group. 
• Anesthesia achieved with a propofol infusion titrated to a RAS score of 3-4. 
• All desaturation points at or below 90% recorded via intraoperative electronic charting (Epic). 
• Frequency and method of intervention aimed at increasing the patient’s saturation by the 
provider will be recorded on the EMR at the time of intervention with a quick note.  
 
5. Sub-Study Procedures: 
N/A 
6. Criteria for Inclusion of Subjects: 
• Age between 18-80 
• Subjects undergoing colonoscopies 
• Morbidly obese BMI ≥ 40 
• STOPBANG score 5 
 
7. Criteria for Exclusion of Subjects: 
• Subjects deemed hemodynamically unstable by the anesthesia team 
• Subjects who are an aspiration risk and will require endotracheal intubation. 
• Pregnancy 
• Subjects with an allergy to propofol 
• Patients who are unable to tolerate the high flow nasal cannula secondary to discomfort 

 
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• Subjects unwilling to sign consent 
• Patients that received medications other than lidocaine and propofol 
 
8. Sources of Research Material: 
• Subjects undergoing colonoscopy 
• Electronic Medical Record 
• Anesthesia Reports 
• PHI including name, medical record number, contact information including demographic 
information including age, gender, race, birth date, weight, height, BMI and medical and 
surgical history, medication list, ASA classification. 
• Procedural sedation-related variables: propofol dose, propofol infusion time, opioid use, 
any other combination agent for the procedural sedation during colonoscopy, Procedure 
time, premature termination of procedure. 
• Respiratory event-related variables; Anesthesiologist intervention (intubation, airway 
repositioning, Chin lift); Type of airway used (oral airway, nasal airway, bag mask 
ventilation, suctioning), Laryngospasm or any other airway obstruction; pulse oximetry 
reading, the number and duration of apnea/hypoxia episodes.  
• Hemodynamic variables such as baseline blood pressure  
• Postoperative Recovery: Aldrete score in recovery, the time spend in PACU 
• Unplanned hospital admission 
• Stop Bang questionnaire for OSA screening  
 
9. Recruitment Methods and Consenting Process: 
All patient recruitment will take place in the GI endoscopy suite. Subject will be identified by 
reviewing daily endoscopy schedule. A designated team of anesthesiologists and nurse 
anesthetists involved in the study will be responsible for screening, consenting and enrolling 
potential subjects. The patient’s chart will be reviewed to determine eligibility with the use of 
a HIPAA waiver form. Information about the study will be given in a pressure-free, 
confidential private area in a face-to-face meeting and the voluntary nature of the research will 
be emphasized to the subjects. 
 
The purpose of the study and risks and potential complications of the study will be explained. 
Adequate time will be given to read consent form to consider whether or not participate in the 
study. All questions will be answered before the patient is asked to sign the consent form. If the 
patient agrees to participate, then he or she will sign the consent form and HIPAA Authorization 
Form prior to any study procedures.  
 
10. Potential Risks: 
This study has minimal risk. The anesthetic management in each group will not differ from the 
current standard of care. 
 
Risk for HFNC: 
HFNC systems deliver heated, humidified gas which may protect airway mucosa. 
  
HFNC may produce distending pressure in the lung, similar to CPAP pressures. There may be 
potentially unpredictable pressures generated by HFNC which may be significant in pediatric but 

 
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not the adult obese population. Mild distending pressure may provide better patent airway in obese 
subjects. Flow rate of HFNC will be adjusted for maximum benefit to the subject (40-60 
L/minutes). The unpredictable distending pressure may cause opening of the narrowed airway or 
cause raptures of small airways. 
 
Psychological Stress: Some of the questions related to the study may make the subject feel 
uncomfortable.  Subjects may refuse to answer any of the questions, or take a break or stop 
participation in the study at any time. 
 
Loss of Confidentiality: Any time information is collected; there is a potential risk of loss of 
confidentiality.  Every effort will be made to keep your information confidential. 
 
11. Subject Safety and Data Monitoring: 
Investigators will ensure patient safety throughout the procedure. This will include following all 
standards of care with regard to conducting a safe anesthetic in the endoscopy suite.  All standard 
ASA monitors will be used, adequate O2 delivery will be ensured and the proper interventions by 
the providers will be carried out during significant desaturation episodes.  Subjects will recover 
from the anesthetic in the endoscopy suite recovery room.  All data will be collected by the EMR 
as per usual (EPIC). 
 
The study PI is responsible for the subject`s safety and data integrity. 
12. Procedures to Maintain Confidentiality: 
All participants will be given an identification number such that identifiable, personal information 
will not be used.  Every effort will be made to keep all data collection sheets confidential and any 
electronic data sets will be password protected and secure. Electronic documents will be de-
identified according to information security policies. Paper documents will be shredded. 
 
13. Potential Benefits: 
There is no benefit to subjects. Use of the Comfort Flo high flow nasal cannula may lead to a 
significant decrease in hypoxic events in morbidly obese, likely sleep apneic, patients undergoing 
deep sedation for colonoscopies. Also, use of a face mask with higher flow rates than the standard 
of care may also lead to a significant decrease in hypoxic events in this population. Information 
gained from this study will increase patient safety and decrease the morbidity and possibly, 
mortality, in this challenging patient population. 
 
14. Biostatistics:  
Data collected from our institution over the last six months revealed a 50% incidence of 
desaturation below 90% during colonoscopies under deep IV sedation in both the standard nasal 
cannula group.  The study is powered to detect a 50% reduction in the frequency of desaturation 
episodes in patients with FM and a 60% reduction in patients with HFNC compared to patients 
using a standard nasal cannula. The study would require a sample of 68 subjects per group to detect 
a difference between 25% desaturation rate in the FM group and 50% desaturation rate in the 
standard nasal cannula group with 80% power and a type 1 error rate of 0.025 using a chi-square 
test with unpooled variance.  With n = 68/group, the study would have 94% power to detect a 
difference of 30% (20% desaturation rate in HFNC versus 50% desaturation rate in standard nasal 

 
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cannula group, type 1 error rate = 0.025).  Assuming a 5% non-completion for various reasons, the 
study will enroll 72 subjects per group resulting in total enrollment of 216 subjects. 
 
Continuous data will be summarized using means and standard deviations and categorical data will 
be summarized using frequencies and percentages.  The two co-primary comparisons of 
proportions of desaturation episodes below 90% in subjects in the face mask and in the HFNC 
groups with that for subjects in the standard nasal cannula group will be done using Z tests with 
unpooled variance.  Each of the two primary comparisons will be done with a type 1 error rate of 
0.025 to maintain the study-wise error rate at 0.05.  A two-sided interim analysis comparing 
desaturation rates in the HFNC and standard nasal cannula groups for futility or early stopping of 
enrollment will be done after 50% enrollment using O’Brien-Fleming method for Lan and Demet’s 
alpha-spending function.   
 
Mean numbers of desaturation episodes and interventions needed to treat hypoxic events will be 
compared using Student’s t-tests or Wilcoxon-Mann-Whitney tests.  Frequencies of sedation-
related adverse events will be compared using chi-square tests or Fisher’s exact tests. Normality 
of the sample data will be assed using normal quantile plots. Level of significance will be set at 
0.05 and Bonferroni corrections will be made for all primary hypotheses tests.  
 
15. References: 
1- Cong Y & Sun X: Mask adaptor—a novel method of positive pressure ventilation during 
propofol deep sedation for upper GI endoscopy. Gastrointestinal Endoscopy, 68(1), 2008, 127-
131. 
2. Goudra BG, Singh PM, Penugonda LC, et al. Significantly reduced hypoxemic events in 
morbidly obese patients undergoing gastrointestinal endoscopy: Predictors and practice effect. J 
Anaesthesiol Clin Pharmacol. 2014; 30(1): 71–77. doi: 10.4103/0970-9185.125707 
3. Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during 
ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009; 54: 1035–40. 
4- Patel A, Nouraei S.A.  Nasal Ventilation: Oxygenation, No DESAT, and THRIVE. Review 
Article. Aug 8, 2016. Anesthesiology News. 
5. Patel A. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a 
physiological method of increasing apnea time in patients with difficult airways. Anesthesia. 2015; 
70(3): 323-329. 
6. Gotera C, et al. “Clinical evidence on high flow oxygen therapy and active humidification in 
adults.” Rev. Port. Pneumol., 19 (5) (2013), pp. 217–227 
7. Spoletini G, et al. Heated humidified high-flow nasal oxygen in adults: mechanisms of action 
and clinical implications CHEST J., 148 (1) (2015), pp. 253–261 
8. Ricard J.D. High flow nasal oxygen in acute respiratory failure.  Minerva Anestesiol., 78 (7) 
2012, 836–841 
9. Lee CC, Mankodi D, Shaharyar S et al. High flow nasal cannula versus conventional oxygen 
therapy and non-invasive ventilation in adults with acute hypoxemic respiratory failure: A 
systematic review Respiratory Medicine, Volume 121, 2016, 100-108 
10. Ritchie JE et al. Evaluation of a humidified nasal high-flow oxygen system, using oxygraphy, 
capnography and measurement of upper airway pressures. Anaesth. Intensive Care, 39 (6) (2011), 
p. 1103 

 
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11. Groves N, Tobin A. High flow nasal oxygen generates positive airway pressure in adult 
volunteers. Aust. Crit. Care, 20 (4) (2007), pp. 126–131 
12. Sotello D, Rivas M, Mulkey Z, Nugent K. High-Flow Nasal Cannula Oxygen in Adult Patients: 
A Narrative Review. Review Article. The American Journal of the Medical Sciences, 349(2), 
2015, 179-185 
13. Chung F, Elsaid H: Screening for obstructive sleep apnea before surgery: why is it important? 
Current Opinion in Anesthesiology: 2009; 22(3): 405–411.  
14. Mehta PP, Kochhar G, Kalra S et al. Can a validated sleep apnea scoring system predict 
cardiopulmonary events using propofol sedation for routine EGD or colonoscopy? A prospective 
cohort study. Gastrointestinal Endoscopy, 2014; 79(3): 436-444. 
15. Manley BJ, Owen LS, Doyle LW, Andersen CC et al. High-Flow Nasal Cannulae in Very 
Preterm Infants after Extubation. N Engl J Med 2013; 369:1425-1433. 
16. John F Nunn. Applied Respiratory Physiology. 3rd edition. Butterworths, 1987. 
 
 

 
 
 
 
A Prospective, Randomized Trial Comparing the Use 
of High Flow Nasal Cannula, Standard Face Mask and 
Standard Nasal Cannula in Morbidly Obese Patients 
with High Risk of Obstructive Sleep Apnea 
Undergoing Colonoscopy 
 
NCT03479905 
 
 
Informed Consent Form (English)  
Document Date 3/12/2018 
 
 
 

Page 1 of 6 
 
The University of Texas Southwestern Medical Center 
Parkland Health & Hospital System 
Children’s Medical Center 
Retina Foundation of the Southwest 
Texas Scottish Rite Hospital for Children 
Texas Health Presbyterian Hospital Dallas 
 
 
CONSENT TO PARTICIPATE IN RESEARCH 
 
 
Title of Research:                 A Prospective, Randomized Trial Comparing the Use of 
High Flow Nasal Cannula, Standard Face Mask and 
Standard Nasal Cannula in Morbidly Obese Patients 
with 
High 
Risk 
of 
Obstructive 
Sleep 
Apnea 
Undergoing Colonoscopy  
 
Funding Agency/Sponsor: 
Department of Anesthesiology and Pain Management, 
UT Southwestern Medical Center 
 
Study Principle Investigator: 
Christina Riccio, MD. 
 
You may call these study doctors or research personnel during regular office hours at 
[469-419-8446].  At other times, you may call them at any time at 214-786-3541. 
 
Instructions: 
Please read this consent form carefully and take your time making a decision about 
whether to participate. Taking part is voluntary. As the researchers discuss this consent 
form with you, please ask him/her to explain any words or information that you do not 
clearly understand. The purpose of the study, risks, inconveniences, discomforts, and 
other important information about the study are listed below. If you chose to take part in 
this study, you will sign this consent form. You will be given a copy to keep for your 
records. 
Why is this study being done? 
Obesity may cause a decrease in blood oxygen levels due to narrowing or closure of 
the airway during sleep (Obstructive Sleep apnea). This study is being done to find out 
whether the High Flow Nasal Cannula (Comfort Flo) can provide better oxygen supply 
to you compared to a standard face mask and a standard Salter nasal cannula during 
sleep (anesthesia sedation) for a colonoscopy.   
 
The following definitions may help you understand this study: 
 Randomization means you will be placed by chance (like drawing straws) into one of 
the three study groups, Salter nasal cannula, standard face mask or the High Flow 
Nasal Cannula (Comfort Flo). 
 Researchers means the study doctor and research personnel at the University of 
Study ID: STU 102017-005   Date Approved: 3/12/2018

Page 2 of 6 
 
Texas Southwestern Medical Center at Dallas and its affiliated hospitals. 
 Standard medical care means the regular care you would receive from your personal 
doctor if you choose not to participate in this research. 
 Body mass index (BMI) is a measure of body fat based on your weight in relation to 
your height. BMI of 40 and above is accepted as extremely high.    
 
Why am I being asked to take part in this research study? 
You are being asked to take part in this study because you have a high risk of 
obstructive sleep apnea due to your high BMI and you will receive deep intravenous (via 
your vein) sedation for your colonoscopy. 
 
Do I have to take part in this research study? 
No.  You have the right to choose whether you want to take part in this research study.  
If you decide to participate and later change your mind, you are free to stop participation 
at any time. If you decide not to take part in this research study it will not change your 
legal rights or the quality of health care that you receive at this center. 
 
How many people will take part in this study? 
About 216 people will take part in this study at Parkland Health Hospital System. 
 
What is involved in the study? 
If you agree to be in this study, you will be asked to sign this consent form. Once the 
researchers determine you can take part in this study, the following procedures will be 
take place:  
 
Procedures and Evaluations during the Research: 
 You will be randomly assigned to the High Flow Nasal cannula (The Comfort Flo 
nasal cannula), standard face mask or standard Salter Cannula group. 
 
 You will fill out a short questionnaire (STOPBANG questionnaire) with 8 ‘Yes’ or 
‘No’ questions to evaluate your risk for narrowing or closure of your airway during 
sleep (obstructive sleep apnea) which is common in obesity. This will take 
approximately 3 minutes. The STOPBANG questionnaire will be used to 
determine your eligibility to participate in this study. If you are not eligible, you will 
be treated with nasal cannula or face mask as standard of care. 
 
 A nasal cannula will be placed in your nostrils. The standard Salter nasal cannula 
is smaller than the Comfort Flo nasal cannula. It will deliver oxygen to you at a 
rate of 4 liter in a minute.  It is not humidified and it will feel dry and cold.   
 
The Comfort Flo nasal cannula is slightly larger than the standard cannula and is 
placed in your nose the same way. It will deliver oxygen to you at 40-60 liters per 
minute and it can feel much stronger than the standard cannula. It is humidified, 
however, and it will feel warm and wet.  
• 
If you are assigned to the standard face mask group, a standard plastic face 
Study ID: STU 102017-005   Date Approved: 3/12/2018

Page 3 of 6 
 
mask will be used to deliver oxygen to you during your colonoscopy. The face 
mask will deliver oxygen to you at a rate of 8 liters per minute.  It is not humidified 
and it will feel dry and cold. 
 
 The investigator will collect information regarding your health status, agents used 
for sedation (sleep), colonoscopy duration, type of airway used, and any airway 
difficulties during your colonoscopy, blood oxygen levels, recovery condition, and 
time spent in the recovery unit after your colonoscopy. This information will be 
collected by reviewing your medical record. 
 
How long can I expect to be in this study? 
You will be in this study during your colonoscopy and recovery after your procedure in 
the Postoperative Anesthesia Care Unit. You can choose to stop participating in this 
study for any reason at any time.  However, if you decide to stop participating in the 
study, we encourage you to tell the researchers.   
 
What are the risks of the study?   
There is minimal risk to subjects by participating in this study. Regardless of 
participating in this research, you will receive oxygen via a nasal cannula. The 
anesthetic management in either group will not differ from the current standard of care. 
You will still receive a general anesthetic medication in your vein for your colonoscopy 
as is done in most endoscopy centers. 
  
Risk for High Flow Nasal Cannula: 
There may be minimal risk for injury in the surface lining of the airways (mucosa) . This 
risk is not higher than the standard nasal cannula because the Comfort Flo nasal 
cannula delivers heated, humidified gas. 
 
The Comfort Flo nasal cannula may produce distending pressure in the lung, similar to 
continuous positive airway pressure which is known as CPAP. There may be potentially 
unpredictable pressures generated by the Comfort Flo nasal cannula which may be 
significant in children but not adults. The unpredictable distending pressure may cause 
opening of the narrowed airway or cause raptures of small airways. The flow rate of 
Comfort Flo nasal cannula will be adjusted for your maximum benefit. 
 
Loss of Confidentiality 
Any time information is collected; there is a potential risk of loss of confidentiality.  Every 
effort will be made to keep your information confidential; however, this cannot be 
guaranteed. 
 
Psychological Stress 
Some of the questions related to the study may make the subject feel uncomfortable.  
You may refuse to answer any of the questions, or take a break or stop participation in 
the study at any time. 
 
Study ID: STU 102017-005   Date Approved: 3/12/2018

Page 4 of 6 
 
Other Risks 
There may possibly be other side effects that are unknown at this time. If you are 
concerned about other, unknown side effects, please discuss this with the researchers. 
 
How will risks be minimized or prevented? 
Your blood pressure, heart rate, oxygen levels and level of sedation will be continuously 
monitored during the colonoscopy by an experienced anesthesia provider. Potential 
risks and discomforts will be minimized to the greatest extent possible and on any 
evidence of an adverse event, the study protocol will be aborted and you will be 
withdrawn from the study. 
 
What are the possible benefits of this study? 
If you agree to take part in this study, there will not be direct benefits to you.  This study 
is intended to evaluate if the Comfort Flo nasal cannula system provides better oxygen 
supply to you during your colonoscopy. 
 
What options are available if I decide not to take part in this research study? 
You do not have to participate in this research to receive care for your medical problem. 
Instead of being in this study, you have the following options: 
 
 Oxygen can be delivered during your colonoscopy with a Salter nasal cannula or 
standard face mask. 
Please talk to the researchers or your personal doctor about these options.  
 
Will I be paid if I take part in this research study?  
No. You will not be paid to take part in this research study.  There are no funds 
available to pay for parking expenses, transportation to and from the research center, 
lost time away from work and other activities, lost wages, or child care expenses. 
 
Will my insurance provider or I be charged for the costs of any part of this 
research study? 
No. Neither you, nor your insurance provider, will be charged for anything done only for 
this research study (i.e., the Screening Procedures, Experimental Procedures, or 
Monitoring/Follow-up Procedures described above).   
 
However, the standard medical care for your condition (care you would have received 
whether or not you were in this study) is your responsibility (or the responsibility of your 
insurance provider or governmental program). You will be charged, in the standard 
manner, for any procedures performed for your standard medical care. 
 
What will happen if I am harmed as a result of taking part in this study? 
It is important that you report any illness or injury to the research team listed at the top 
of this form immediately.  Compensation for an injury resulting from your participation in 
this research is not available from the University of Texas Southwestern Medical Center 
Study ID: STU 102017-005   Date Approved: 3/12/2018

Page 5 of 6 
 
at Dallas or Parkland Health and Hospital System. You retain your legal rights during 
your participation in this research. 
 
Can I stop taking part in this research study? 
Yes.  If you decide to participate and later change your mind, you are free to stop taking 
part in the research study at any time. 
If you decide to stop taking part in this research study, it will not affect your relationship 
with the UT Southwestern staff or doctors.  Whether you participate or not will have no 
effect on your legal rights or the quality of your health care. 
 
If you are a medical student, fellow, faculty, or staff at the Medical Center, your status 
will not be affected in any way. Your doctor is a research investigator in this study.  S/he 
is interested in both your medical care and the conduct of this research study.  At any 
time, you may discuss your care with another doctor who is not part of this research 
study.  You do not have to take part in any research study offered by your doctor. 
 
Will my information be kept confidential? 
Medical information collected during this study and the results of any test or procedure 
that may affect your medical care may be included in your medical record. The 
information included in your medical record will be available to health care providers 
and authorized persons including your insurance company. 
 
You should know that certain organizations that may look at and/or copy your medical 
records for research, quality assurance, and data analysis include: 
 
• 
Representatives of government agencies, like the Food and Drug Administration 
(FDA), involved in keeping research safe for people, and 
• 
The UT Southwestern Institutional Review Board.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify you.  
At most, the Web site will include a summary of the results.  You can search this Web 
site at any time. 
 
In addition to this consent form, you will be asked to sign an "Authorization for Use and 
Disclosure of Protected Health Information."  This authorization will give more details 
about how your information will be used for this research study, and who may see 
and/or get copies of your information. 
 
Whom do I call if I have questions or problems? 
For questions about the study, contact Dr. Christina Riccio at 469-419-8446 during 
regular business hours and at any time at 214-786-3541.  
 
For questions about your rights as a research participant, contact the UT Southwestern 
Institutional Review Board (IRB) Office at 214-648-3060. 
Study ID: STU 102017-005   Date Approved: 3/12/2018

Page 6 of 6 
 
 
SIGNATURES: 
 
YOU WILL BE GIVEN A COPY OF THIS CONSENT FORM TO KEEP. 
Your signature below certifies the following: 
 You have read (or been read) the information provided above. 
 You have received answers to all of your questions and have been told who to 
call if you have any more questions. 
 You have freely decided to participate in this research. 
 You understand that you are not giving up any of your legal rights. 
 You understand that a copy of this signed consent document, information about 
this study, and the results of any test or procedure that may affect your medical 
care, may be included in your medical record.  The information included in your 
medical record will be available to your health care providers and other 
authorized persons including your insurance company. 
 
 
____________________________________________ 
 
 
Name of Participant (Printed) 
 
 
 
 
____________________________________________ 
________ 
_______ AM / PM 
Signature of Participant 
 
Date 
Time 
 
____________________________________________ 
 
 
Name of Person Obtaining Consent (Printed) 
 
 
 
____________________________________________ 
________ 
_______ AM / PM 
Signature of Person Obtaining Consent 
Date 
Time 
 
 
 
Study ID: STU 102017-005   Date Approved: 3/12/2018

 
 
 
 
A Prospective, Randomized Trial Comparing the Use 
of High Flow Nasal Cannula, Standard Face Mask and 
Standard Nasal Cannula in Morbidly Obese Patients 
with High Risk of Obstructive Sleep Apnea 
Undergoing Colonoscopy 
 
NCT03479905 
 
 
Informed Consent Form (Spanish)  
Date 3/12/2018 
 
 
 

 
 
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PROHIBIDA SU DIVULGACIÓN 
The University of Texas Southwestern Medical Center  
Parkland Health & Hospital System 
Children’s Medical Center 
Retina Foundation of the Southwest 
Texas Scottish Rite Hospital for Children 
Texas Health Presbyterian Hospital Dallas 
 
DECLARACIÓN DE CONSENTIMIENTO INFORMADO  
PARA PARTICIPACIÓN EN UNA INVESTIGACIÓN MÉDICA 
 
 
Título de la Investigación: 
Ensayo futuro, aleatorio, que compara el uso de cánulas 
nasales de alto flujo, mascarillas estándares y cánulas 
nasales estándares en pacientes con obesidad mórbida en 
alto riesgo de apnea obstructiva del sueño durante una 
colonoscopía 
 
Agencia Patrocinadora: 
Departamento de Anestesiología y Manejo del Dolor, UT 
Southwestern Medical Center 
 
Médicos Encargados  
del Estudio: 
Christina Riccio MD.  
 
 
Usted puede comunicarse con los médicos o personal encargado de la investigación, 
llamando durante horas regulares de oficina al [469-419-8446]. Fuera de las horas regulares 
de oficina, puede comunicarse con ellos al [214-786-3541]. 
 
Instrucciones: 
Por favor lea cuidadosamente este formulario de consentimiento y tome su tiempo para decidir 
si desea participar en el estudio. Cuando los investigadores conversen con usted sobre este 
formulario, pídales que le expliquen cualquier palabra o información que no comprenda con 
claridad. A continuación encontrará el propósito, riesgos, inconvenientes, molestias y demás 
información importante relacionada con el estudio. Si decide participar, le proporcionaremos 
una copia de este formulario para sus archivos. 
 
¿Por qué están realizando este estudio? 
La obesidad puede provocar una disminución de los niveles de oxígeno en la sangre debido al 
estrechamiento o cierre de las vías respiratorias durante el sueño (apnea obstructiva del 
sueño). Estamos realizando este estudio para determinar si la cánula nasal de alto flujo 
(Comfort Flo) puede mejorar el suministro de oxígeno en comparación con una mascarilla 
estándar y una cánula nasal Salter estándar durante el sueño (sedación por anestesia) para la 
colonoscopía. 
Las siguientes definiciones pueden ayudarlo a comprender mejor este estudio: 
 
 Aleatoriedad significa que se asignará al participante indistintamente (al azar, como si 
se lanzara una moneda al aire) a cualquiera de los grupos de estudio: con la cánula 
nasal Salter o con la cánula nasal de alto flujo (Comfort Flo).  
Study ID: STU 102017-005   Date Approved: 3/12/2018

 
 
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PROHIBIDA SU DIVULGACIÓN 
 Investigadores se refiere a los médicos encargados del estudio y el personal en 
University of Texas Southwestern Medical Center en Dallas y sus hospitals afiliados. 
 Asistencia médica regular se refiere al cuidado que recibiría usted normalmente a 
través de su médico de cabecera si decidiera no participar en esta investigación. 
 El índice de masa corporal (BMI, por sus siglas en inglés) es una medición de la grasa 
corporal que se basa en el peso con relación a la estatura. Un BMI de 40 o superior se 
considera sumamente alto. 
 
 
¿Por qué me han pedido que participe en esta investigación?  
Se le ha pedido que participe en este estudio porque tiene un alto riesgo de apnea obstructiva 
del sueño debido a su alto índice de masa corporal, y recibirá sedación profunda por vía 
intravenosa (a través de una vena) para la colonoscopía. 
 
¿Tengo que participar en este estudio de investigación? 
No, usted tiene derecho a decidir si desea o no participar en este estudio de investigación. Si 
decide hacerlo y posteriormente cambia de opinión, estará en libertad de suspender su 
participación en cualquier momento que desee. Si por el contrario decide no participar en este 
estudio de investigación, sepa que su decisión no cambiará sus derechos legales ni la calidad 
de asistencia médica que reciba en este centro. 
 
¿Cuántas personas participarán en este estudio? 
Participarán aproximadamente unas 216 personas en este estudio que se realizara en 
Parkland Health & Hospital System.  
 
¿Qué pasos involucra este estudio? 
Si acepta participar en este estudio, se le pedirá que firme este formulario de consentimiento. 
Una vez que los investigadores determinen que puede usted participar en este estudio, se 
levarán a cabo los siguientes procedimientos: 
 
Procedimientos y evaluaciones durante la investigación: 
 Se le asignará al azar al grupo de cánula nasal de alto flujo (la cánula nasal Comfort 
Flo), al grupo de mascarilla estándar o al grupo de cánula Salter estándar. 
 
 Debe completar un breve cuestionario (cuestionario STOPBANG) de 8 preguntas con 
“Sí” o “No” para evaluar su riesgo de un estrechamiento o cierre de las vías 
respiratorias durante el sueño (apnea obstructiva del sueño), que es frecuente en 
pacientes con obesidad. Esto tomará aproximadamente 3 minutos. El cuestionario 
STOPBANG se utilizará a fin de determinar su elegibilidad para participar en este 
estudio. Si usted no es elegible, se le dará tratamiento con una cánula nasal o una 
mascarilla de acuerdo con las normas estándar de atención. 
 
 Se le colocará una cánula nasal en las fosas nasales. La cánula nasal Salter estándar 
es más pequeña que la cánula nasal Comfort Flo. Le suministrará oxígeno a razón de 
4 litros por minuto. No está humidificada y sentirá frío y resequedad.  
 
La cánula nasal Comfort Flo es ligeramente más grande que la cánula nasal estándar, y se 
coloca en la nariz de la misma manera. Le suministrará oxígeno a razón de 40 a 60 litros por 
Study ID: STU 102017-005   Date Approved: 3/12/2018

 
 
Página 3 de 6 
PROHIBIDA SU DIVULGACIÓN 
minuto, y sentirá una presión de aire mucho más intensa que con la cánula estándar. Sin 
embargo, está humidificada, y sentirá humedad y calor.  
 Si se le asigna al grupo de la mascarilla estándar, se utilizará una mascarilla de plástico 
estándar para suministrarle oxígeno durante la colonoscopía. Esta mascarilla le 
suministrará oxígeno a razón de 8 litros por minuto. No está humidificada y usted la 
sentirá seca y fría. 
 
 El investigador recopilará información acerca de su estado de salud, sustancias 
utilizadas para sedación (sueño), duración de la colonoscopia, tipo de vía respiratoria 
que se utiliza, dificultades respiratorias (si las hubiera) durante la colonoscopia, presión 
arterial, nivel de oxígeno en sangre, estado de recuperación y tiempo en la sala de 
recuperación después de la colonoscopia. Esta información se recopilará mediante la 
revisión de su expediente médico. 
 
¿Cuánto durará mi participación en este estudio? 
Participará en este estudio durante la colonoscopia y la recuperación de la colonoscopia en la 
Unidad de Atención Posoperatoria con Anestesia. Usted puede elegir dejar de participar en 
este estudio por cualquier motivo y en cualquier momento. Sin embargo, si decide dejar de 
participar en el estudio, le recomendamos que se lo informe a los investigadores. 
 
¿Cuáles son los riesgos involucrados en este estudio? 
Hay un riesgo mínimo para los sujetos que participan en este estudio. Independientemente de 
que participe o no en el estudio, recibirá oxígeno a través de una cánula nasal. La 
administración de anestesia en ambos grupos será igual a la atención estándar actual.  
Recibirá medicamento de anestesia por vía intravenosa para la colonoscopia, como suele 
hacerse en casi todos los centros de endoscopia. 
 
Riesgo para la cánula nasal de alto flujo 
Existe un riesgo mínimo de sufrir lesiones en el revestimiento externo de las vías respiratorias 
(mucosa). Este riesgo no es mayor que el de la cánula nasal estándar porque la cánula nasal 
Comfort Flo administra gas calentado y humidificado. 
 
La cánula nasal Comfort Flo puede producir presión de distensión en los pulmones, similar a la 
presión positiva continua de las vías respiratorias (CPAP, por sus siglas en inglés). Podría 
haber presiones potencialmente impredecibles generadas por la cánula nasal Comfort Flo, 
que pueden ser considerables en niños, pero no en adultos. La impredecible presión de 
distensión podría causar la apertura de la vía respiratoria estrechada u ocasionar rupturas en 
las vías respiratorias pequeñas. La velocidad de flujo de la cánula nasal Comfort Flo se 
ajustará para brindarle el máximo beneficio. 
 
Pérdida de Confidencialidad 
En cualquier momento se recopila información; Existe un riesgo potencial de pérdida de 
confidencialidad. Se hará todo lo posible para mantener su información confidencial; Sin 
embargo, esto no puede ser garantizado. 
 
Estrés Psicológico 
Algunas de las preguntas relacionadas con el estudio pueden hacer que el sujeto se sienta 
incómodo. Usted puede negarse a contestar cualquiera de las preguntas, o hacer una pausa o 
Study ID: STU 102017-005   Date Approved: 3/12/2018

 
 
Página 4 de 6 
PROHIBIDA SU DIVULGACIÓN 
dejar de participar en el estudio en cualquier momento. 
 
Otros Riesgos 
Puede haber otros efectos secundarios que se desconocen en este momento. Si le preocupan 
otros efectos secundarios desconocidos, por favor hable con los investigadores. 
 
¿Cómo se minimizan o evitan riesgos? 
Durante la colonoscopía, un anestesista experimentado estará monitorizando constantemente 
su presión arterial, frecuencia cardíaca, niveles de oxígeno y nivel de sedación. Los riesgos y 
molestias potenciales se minimizarán en la mayor medida posible y, si hay evidencia de un 
suceso adverso, se cancelará el protocolo del estudio y se le retirará a usted del estudio. 
 
¿Cuáles son los posibles beneficios de este estudio? 
Si acepta participar en este estudio, no habrá beneficios directos para usted. 
Este estudio tiene el propósito de evaluar si el sistema de la cánula nasal Comfort Flo le 
proporciona mejor suministro de oxígeno a usted durante la colonoscopia.  
 
¿Cuáles son mis opciones si decido no participar en este estudio de investigación? 
Usted no tiene que participar en esta investigación para recibir atención médica para su 
problema. En lugar de estar en este estudio, tiene las siguientes opciones:  
 Durante la colonoscopía, se le puede suministrar oxígeno por medio de una cánula 
nasal Salter o una mascarilla estándar. 
 
Hable con los investigadores o con su médico personal sobre estas opciones.  
 
¿Me pagarán si participo en este estudio de investigación? 
No hay fondos disponibles para cubrir gastos de estacionamiento, traslado de ida y vuelta al 
centro de investigaciones ni para cubrir horas de trabajo u otras actividades perdidas así como 
salarios no recibidos o gastos por el cuidado de niños. 
 
¿Le cobrarán a mi compañía de seguros o a mí por alguna parte de este estudio de 
investigación? 
No. Ni usted, ni su proveedor de seguros, se le cobrará por cualquier cosa hecha sólo para 
este estudio de investigación (es decir, los procedimientos de detección, Procedimientos 
experimentales, o un control / seguimiento de los procedimientos descritos anteriormente).  
 
Sin embargo, la atención médica estándar para su condición (sin importar que hubiera recibido 
está o no estuviera en este estudio) es su responsabilidad (o la responsabilidad de su 
proveedor de seguros o programa gubernamental). Se le cobrará, de la manera estándar, por 
cualquier procedimiento realizado por su atención médica estándar.  
 
¿Qué sucede si me lesiono al participar en este estudio? 
Es importante que informe de cualquier enfermedad o lesión al equipo de investigación que 
aparece en la parte superior de este formulario inmediatamente. No habrá compensación 
disponible para lesiones sufridas al participar en esta investigación, por parte de The 
University of Texas Southwestern Medical Center at Dallas ni Parkland Health & Hospital 
System. 
Study ID: STU 102017-005   Date Approved: 3/12/2018

 
 
Página 5 de 6 
PROHIBIDA SU DIVULGACIÓN 
 
Usted conserva sus derechos legales durante su participación en esta investigación.  
 
Puedo dejar de ser parte de este estudio de investigación? 
Sí. Si decide participar y luego cambia de opinión, usted es libre de dejar de participar en el 
estudio de investigación en cualquier momento.  
 
Si decide dejar de tomar parte en este estudio de investigación, no afectará a su relación con el 
personal de UT Southwestern o médicos. Ya sea que participe o no tendrá ningún efecto sobre 
sus derechos legales o la calidad de su atención médica.  
 
Si usted es un estudiante de medicina, compañeros, profesores o personal del Centro Médico, 
su estado no se verá afectado de ninguna manera.  
 
Su médico es un investigador de la investigación en este estudio. Ei/ella está interesado tanto 
en su atención médica y la realización de este estudio de investigación. En cualquier 
momento, usted puede discutir su tratamiento con otro médico que no es parte de este estudio 
de investigación. Usted no tiene que participar en cualquier estudio de investigación ofrecida 
por su médico.  
 
¿Se resguardará la confidencialidad de mi información? 
Podríamos incluir, en su registro médico, la información recaudada durante este estudio así 
como los resultados de cualquier examen o procedimiento realizado, lo cual pueda afectar la 
asistencia médica que usted reciba. La información incluida quedará a disposición de los 
proveedores médicos y personal autorizado, incluyendo a su compañía de seguro.  
 
Como sabrá, entre las organizaciones que pueden mirar o fotocopiar su historial médico para 
propósitos de investigación, control de calidad y análisis de datos se incluyen:  
 
 Representantes de agencias gubernamentales como the US Food and Drug 
Administration o FDA, interesadas en mantener la seguridad de la investigación médica 
para los participantes, y 
 UT Southwestern Institutional Review Board (Junta de Revisión Institucional)  
 
Según lo requerido por la ley, habrá una descripción de esta investigación en la Internet, en el 
http://www.ClinicalTrials.gov. Esta página web no incluye, sin embargo, información que 
pueda identificar a los participantes. A lo sumo, incluye un resumen de los resultados 
obtenidos. Usted puede visitar esta página web en cualquier momento que desee. 
 
Además de este formulario, se le pedirá que firme la “Autorización para el Uso y Divulgación de 
Información Médica Protegida” o "Authorization for Use and Disclosure of Protected Health 
Information", como se le conoce en inglés. Esta autorización le proporcionará más detalles 
sobre cómo se utilizará su información para este estudio y quiénes pueden mirar o fotocopiar 
la misma. 
 
¿A quién debo llamar si tengo dudas, preguntas o algún problema? 
Si usted tiene dudas o preguntas sobre el estudio, comuníquese con la Dra. Christina Riccio al 
469-419-8446 durante horas regulares de oficina y al 214-786-3541 después de horas de 
Study ID: STU 102017-005   Date Approved: 3/12/2018

 
 
Página 6 de 6 
PROHIBIDA SU DIVULGACIÓN 
oficina, durante los fines de semana y días festivos. 
 
Para preguntas sobre sus derechos como participante en esta investigación, comuníquese 
con la oficina de The UT Southwestern Institutional Review Board (IRB) al 214-648-3060 
 
 
FIRMAS: 
LE ENTREGAREMOS UNA COPIA DE ESTE  
FORMULARIO DE CONSENTIMIENTO PARA SUS ARCHIVOS. 
 
Su firma a continuación certifica lo siguiente: 
 Ha leído (o le han leído) la información suministrada arriba. 
 Ha recibido las respuestas a todas sus preguntas y le han dicho a quién llamar en caso 
de que tenga alguna pregunta más. 
 Ha decidido de su propia voluntad participar en esta investigación. 
 Entiende que no está renunciando a ninguno de sus derechos legales. 
 Usted entiende que existe la posibilidad de que en su historial médico se incluyan una 
copia firmada de este consentimiento, información sobre este estudio y los resultados 
de cualquier prueba o procedimiento realizado, lo cual podría afectar su asistencia 
médica. La información incluida en su historial médico estará a la disposición de los 
proveedores de atención médica y a las personas autorizadas, incluso a su compañía 
de seguro médico. 
 
 
 
 
 _______________________________________________  
 
Nombre del Participante  
(escrito en letra de molde) 
 
 _______________________________________________  
 ________  
 __________ AM/PM 
Firma del Participante 
Fecha 
Hora 
 
 _______________________________________________  
 
Nombre de la Persona que Obtuvo el Consentimiento  
(escrito en letra de molde) 
 
 _______________________________________________  
 ________  
 __________ AM/PM 
Firma de la Persona que Obtuvo el Consentimiento 
Fecha 
Hora 
 
 
Study ID: STU 102017-005   Date Approved: 3/12/2018