O2C2: Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02741284
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 2
• Duration (Months): 54
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is common practice on Labor and Delivery units in the United States. Despite the broad use of oxygen, it is unclear if this practice is beneficial for the fetus. The purpose of this study is to compare oxygen to room air in patients with Category II fetal heart tracings with regard to neonatal acid-base status, subsequent tracings, and production of reactive oxygen species

Condition or Disease	Intervention/Treatment	Phase
Electronic Fetal Monitoring; Fetal Hypoxia; Fetal-Placental Circulation	Drug: Room air; Drug: 10L Oxygen by nonrebreather mask	N/A

Detailed Description

Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is common practice on Labor and Delivery units in the United States. Despite the broad use of oxygen, it is unclear if this practice is beneficial for the fetus. Category II FHT, as defined by the National Institute of Child Health and Human Development (NICHD) (Robinson), is a broad class of FHT patterns that may suggest cord compression and/or placental insufficiency for which oxygen is most commonly administered. Although some animal and human studies (Khazin, Althabe) have demonstrated that maternal hyperoxygenation can alleviate such fetal heart rate decelerations, this purported benefit has not been shown to translate into improved fetal outcomes, particularly in relation to acid-base status. In fact, some studies suggest harm with oxygen use due to lower umbilical artery pH and increased delivery room resuscitation (Nesterenko, Thorp) or increased free radical activity (Khaw). Given the indeterminate evidence for this ubiquitously employed resuscitation technique, there is an urgent need to further study the utility of maternal oxygen administration in labor for fetal benefit.

We propose a randomized controlled non-inferiority trial comparing oxygen to room air in patients with Category II FHT. Our central hypothesis is that room air alone is not inferior to oxygen administration with regard to neonatal acid-base status and FHT and may in fact, be a safer option for resuscitation due to less production of reactive oxygen species.

Primary Aim: Determine the effect of maternal oxygen administration for Category II FHT on arterial umbilical cord lactate.

Hypothesis: Room air, as a substitute for oxygen supplementation, is no different than oxygen in altering the acid-base status of the neonate as reflected in umbilical arterial (UA) lactate.

Fetal hypo-oxygenation, as reflected by decelerations in the FHT, results in metabolic acidosis due to a shift from aerobic to anaerobic metabolism in which lactate and hydrogen ion production significantly increase causing a decrease in pH (Tuuli). Elevated umbilical cord lactate has been shown to be a surrogate for fetal metabolic acidosis and resultant neonatal morbidity (Tuuli, Westgren). The theorized benefit of maternal oxygen administration is increased oxygen delivery to the fetus resulting in reversal of anaerobic metabolism/ metabolic acidosis. This, however, has not been substantiated by evidence thus far. Women with persistent Category II FHT tracing will be randomly assigned to supplemental oxygen or room air. The primary outcome will be umbilical arterial lactate level, and secondary outcomes will be other umbilical cord gas parameters including UA pH, UV oxygen saturation, and UA base deficit.

Secondary Aim #1: Characterize the effect of oxygen administration on fetal heart tracing patterns Hypothesis: Oxygen administration will be associated with a rate of persistent Category II FHT that is not different from those exposed to room air.

Oxygen is typically administered as a response to FHT interpretation. Evidence thus far shows that Category II FHT are associated with a wide spectrum of neonatal outcomes and therefore do not uniformly reflect fetal acid-base status (Cahill, Frey). Hence, evaluating the effect of oxygen on subsequent FHT categorization is pivotal to labor management. The outcome that will be investigated is rate of persistent Category II FHT after intervention.

Secondary Aim #2: Evaluate the safety of oxygen administration by measuring reactive oxygen species (ROS) in maternal and neonatal blood.

Hypothesis: Oxygen administration will be associated with increased oxidative stress in maternal and neonatal cord blood as represented by malondialdehyde (MDA).

Over-oxygenation can result in free radical or ROS formation that have detrimental downstream effects. The presence of reactive oxygen species results in degradation of lipids in the cell membrane and resultant formation of malondialdehyde (MDA) (Dalle-Donne), which has been studied as a surrogate for oxidative stress (Ilhan, Pryor, Suhail, Lorente).

This study will be a prospective, randomized non inferiority trial to be conducted a single center. This study will include term, singleton patients admitted to Labor& Delivery for spontaneous labor or labor induction. Multiples, significant fetal anomalies, Category III FHT, umbilical artery doppler abnormalities and preterm pregnancies will be excluded. Additionally, women will be excluded if oxygen is required for maternal indications such as hypooxygenation or cardiopulmonary disease. Our primary objective will be umbilical cord lactate. Secondary objectives include additional cord gas parameters including umbilical artery pH, umbilical artery base deficit, and umbilical vein oxygen saturation; FHT categorization and deceleration patterns; maternal and umbilical cord blood measurement of malondialdehyde. Women will be consented at time of admission for labor and randomized when at least 6cm dilated with Category II FHT necessitating provider intervention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Oxygen for Category II Intrauterine Fetal Resuscitation: A Randomized, Noninferiority Trial
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: No Oxygen Room air	Drug: Room air
Active Comparator: Oxygen 10L oxygen by nonrebreather mask	Drug: 10L Oxygen by nonrebreather mask

Outcome Measures

Primary Outcome Measures

1. Mean Umbilical Artery Lactate at Delivery [At delivery]

   Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.

Secondary Outcome Measures

1. Umbilical Artery pH [At time of delivery]

   Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.

2. Mode of Delivery [At delivery]

   Delivery via Cesarean section, operative vaginal delivery (forceps or vacuum), or spontaneous vaginal delivery

3. Umbilical Artery pCO2 [At time of delivery]

   Partial pressure of carbon dioxide as collected on cord gases at time of delivery

4. Umbilical Artery pO2 [Time of delivery]

   Partial pressure of oxygen as collected on cord gases at time of delivery

5. Umbilical Artery Base Deficit [At time of delivery]

   As determined by cord gas collection at time of delivery

Other Outcome Measures

1. Number of Patients With Resolved Recurrent Decelerations [60 minutes after randomization]

   Number of patients with resolution of recurrent variable or recurrent late decelerations within 60 minutes of randomization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Term, singleton patients admitted to Labor& Delivery for spontaneous labor or labor induction

Exclusion Criteria:

• Multiple pregnancy

• Significant fetal anomalies

• Category III FHT

• Umbilical artery doppler abnormalities

• Maternal hypooxygenation or need for oxygen

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 2, 2016

More Information

Publications

• Althabe O Jr, Schwarcz RL, Pose SV, Escarcena L, Caldeyro-Barcia R. Effects on fetal heart rate and fetal pO2 of oxygen administration to the mother. Am J Obstet Gynecol. 1967 Jul 15;98(6):858-70.
• Cahill AG, Roehl KA, Odibo AO, Macones GA. Association and prediction of neonatal acidemia. Am J Obstet Gynecol. 2012 Sep;207(3):206.e1-8. doi: 10.1016/j.ajog.2012.06.046.
• Dalle-Donne I, Rossi R, Colombo R, Giustarini D, Milzani A. Biomarkers of oxidative damage in human disease. Clin Chem. 2006 Apr;52(4):601-23. Epub 2006 Feb 16. Review.
• Frey HA, Tuuli MG, Shanks AL, Macones GA, Cahill AG. Interpreting category II fetal heart rate tracings: does meconium matter? Am J Obstet Gynecol. 2014 Dec;211(6):644.e1-8. doi: 10.1016/j.ajog.2014.06.033. Epub 2014 Jun 17.
• Ilhan N, Ilhan N, Simsek M. The changes of trace elements, malondialdehyde levels and superoxide dismutase activities in pregnancy with or without preeclampsia. Clin Biochem. 2002 Jul;35(5):393-7.
• Khaw KS, Wang CC, Ngan Kee WD, Pang CP, Rogers MS. Effects of high inspired oxygen fraction during elective caesarean section under spinal anaesthesia on maternal and fetal oxygenation and lipid peroxidation. Br J Anaesth. 2002 Jan;88(1):18-23.
• Khazin AF, Hon EH, Hehre FW. Effects of maternal hyperoxia on the fetus. I. Oxygen tension. Am J Obstet Gynecol. 1971 Feb 15;109(4):628-37.
• Lorente L, Martín MM, Abreu-González P, Domínguez-Rodriguez A, Labarta L, Díaz C, Solé-Violán J, Ferreres J, Cabrera J, Igeño JC, Jiménez A. Sustained high serum malondialdehyde levels are associated with severity and mortality in septic patients. Crit Care. 2013 Dec 11;17(6):R290. doi: 10.1186/cc13155.
• Lorente L, Martín MM, Abreu-González P, Ramos L, Argueso M, Cáceres JJ, Solé-Violán J, Lorenzo JM, Molina I, Jiménez A. Association between serum malondialdehyde levels and mortality in patients with severe brain trauma injury. J Neurotrauma. 2015 Jan 1;32(1):1-6. doi: 10.1089/neu.2014.3456.
• Nesterenko TH, Acun C, Mohamed MA, Mohamed AN, Karcher D, Larsen J Jr, Aly H. Is it a safe practice to administer oxygen during uncomplicated delivery: a randomized controlled trial? Early Hum Dev. 2012 Aug;88(8):677-81. doi: 10.1016/j.earlhumdev.2012.02.007. Epub 2012 Mar 23.
• Pryor WA, Stanley JP. Letter: A suggested mechanism for the production of malonaldehyde during the autoxidation of polyunsaturated fatty acids. Nonenzymatic production of prostaglandin endoperoxides during autoxidation. J Org Chem. 1975 Nov 28;40(24):3615-7.
• Robinson B, Nelson L. A Review of the Proceedings from the 2008 NICHD Workshop on Standardized Nomenclature for Cardiotocography: Update on Definitions, Interpretative Systems With Management Strategies, and Research Priorities in Relation to Intrapartum Electronic Fetal Monitoring. Rev Obstet Gynecol. 2008 Fall;1(4):186-92.
• Suhail M, Suhail S, Gupta BK, Bharat V. Malondialdehyde and Antioxidant Enzymes in Maternal and Cord Blood, and their Correlation in Normotensive and Preeclamptic Women. J Clin Med Res. 2009 Aug;1(3):150-7. doi: 10.4021/jocmr2009.07.1252. Epub 2009 Aug 12.
• Thorp JA, Trobough T, Evans R, Hedrick J, Yeast JD. The effect of maternal oxygen administration during the second stage of labor on umbilical cord blood gas values: a randomized controlled prospective trial. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):465-74.
• Tuuli MG, Stout MJ, Shanks A, Odibo AO, Macones GA, Cahill AG. Umbilical cord arterial lactate compared with pH for predicting neonatal morbidity at term. Obstet Gynecol. 2014 Oct;124(4):756-761. doi: 10.1097/AOG.0000000000000466.
• Westgren M, Divon M, Horal M, Ingemarsson I, Kublickas M, Shimojo N, Nordström L. Routine measurements of umbilical artery lactate levels in the prediction of perinatal outcome. Am J Obstet Gynecol. 1995 Nov;173(5):1416-22.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02741284
• Other Study ID Numbers: 201602164
• First Posted: Apr 18, 2016
• Last Update Posted: Nov 26, 2021
• Last Verified: Nov 1, 2021

• Additional relevant MeSH terms: Fetal Hypoxia; Hypoxia

Study Results

Participant Flow

Arm/Group Title	Room Air	Oxygen
Arm/Group Description	Room air, no mask	10L oxygen by nonrebreather mask
Period Title: Overall Study
STARTED	57	57
COMPLETED	51	48
NOT COMPLETED	6	9

Baseline Characteristics

Arm/Group Title	Room Air	Oxygen	Total
Arm/Group Description	Room air, no mask	10L oxygen by nonrebreather mask	Total of all reporting groups
Overall Participants	51	48	99
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.8 (5.3)	27.3 (6.3)	27.5 (5.8)
Sex: Female, Male (Count of Participants)
Female	51 100%	48 100%	99 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	3 6.3%	3 3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	40 78.4%	36 75%	76 76.8%
White	10 19.6%	8 16.7%	18 18.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2%	1 2.1%	2 2%
Body mass index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	27.7 (7.3)	26.9 (6.5)	27.3 (6.9)
Gestational age at delivery (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	39.1 (1.1)	39.2 (1.1)	39.1 (1.1)
Nulliparity (Count of Participants)
Count of Participants [Participants]	6 11.8%	5 10.4%	11 11.1%
Chronic hypertension (Count of Participants)
Count of Participants [Participants]	6 11.8%	3 6.3%	9 9.1%
Preeclampsia (Count of Participants)
Count of Participants [Participants]	3 5.9%	0 0%	3 3%
Pregestational diabetes (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%
Tobacco use (Count of Participants)
Count of Participants [Participants]	8 15.7%	6 12.5%	14 14.1%
Illicit drug use (Count of Participants)
Count of Participants [Participants]	8 15.7%	12 25%	20 20.2%
Alcohol (Count of Participants)
Count of Participants [Participants]	2 3.9%	0 0%	2 2%
Induction of labor (Count of Participants)
Count of Participants [Participants]	36 70.6%	34 70.8%	70 70.7%
Oxytocin (Count of Participants)
Count of Participants [Participants]	45 88.2%	43 89.6%	88 88.9%
Chorioamnionitis (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%
Epidural (Count of Participants)
Count of Participants [Participants]	50 98%	44 91.7%	94 94.9%
Hematocrit on admission (Percentage of red blood cells) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of red blood cells]	32.5 (3.2)	32.8 (3.5)	32.6 (3.3)

Outcome Measures

1. Primary Outcome

Title	Mean Umbilical Artery Lactate at Delivery
Description	Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.
Time Frame	At delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Room Air	Oxygen
Arm/Group Description	Room air, no mask	10L oxygen by nonrebreather mask
Measure Participants	51	48
Mean (95% Confidence Interval) [mmol/L]	3.5	3.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Room Air, Oxygen
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	A noninferiority margin of 30% (mean difference <1.0 mmol/l) was pre-specified as it corresponds to an upper umbilical artery lactate cut-off value of 4.5 mmol/L, above which there is an increased risk of neonatal morbidity
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.5 to 0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Umbilical Artery pH
Description	Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.
Time Frame	At time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Room Air	Oxygen
Arm/Group Description	Room air, no mask	10L oxygen by nonrebreather mask
Measure Participants	51	48
Mean (95% Confidence Interval) [pH units]	7.26	7.25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Room Air, Oxygen
	Comments	pH
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority margin 30%
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Mode of Delivery
Description	Delivery via Cesarean section, operative vaginal delivery (forceps or vacuum), or spontaneous vaginal delivery
Time Frame	At delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Room Air	Oxygen
Arm/Group Description	Room air, no mask	10L oxygen by nonrebreather mask
Measure Participants	51	48
Cesarean delivery	2 3.9%	6 12.5%
Cesarean delivery for non reassuring fetal status	0 0%	2 4.2%
Operative vaginal delivery	6 11.8%	1 2.1%
Spontaenous vaginal delivery	43 84.3%	41 85.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Room Air, Oxygen
	Comments	Cesarean delivery
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95%; 0.07 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Room Air, Oxygen
	Comments	Cesarean delivery for non reassuring fetal status
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; 0 to 0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Room Air, Oxygen
	Comments	Operative vaginal delivery
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	5.65
	Confidence Interval	(2-Sided) 95%; 0.71 to 45.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Umbilical Artery pCO2
Description	Partial pressure of carbon dioxide as collected on cord gases at time of delivery
Time Frame	At time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Room Air	Oxygen
Arm/Group Description	Room air, no mask	10L oxygen by nonrebreather mask
Measure Participants	51	48
Mean (95% Confidence Interval) [mmHg]	55.9	57.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Room Air, Oxygen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.5
	Confidence Interval	(2-Sided) 95%; -5.4 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Umbilical Artery pO2
Description	Partial pressure of oxygen as collected on cord gases at time of delivery
Time Frame	Time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Room Air	Oxygen
Arm/Group Description	Room air, no mask	10L oxygen by nonrebreather mask
Measure Participants	51	48
Mean (95% Confidence Interval) [mm Hg]	19.7	24.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Room Air, Oxygen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.7
	Confidence Interval	(2-Sided) 95%; -9.6 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Umbilical Artery Base Deficit
Description	As determined by cord gas collection at time of delivery
Time Frame	At time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Room Air	Oxygen
Arm/Group Description	Room air, no mask	10L oxygen by nonrebreather mask
Measure Participants	51	48
Mean (95% Confidence Interval) [meq/L]	-3.6	-3.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Room Air, Oxygen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -1.0 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Other Pre-specified Outcome

Title	Number of Patients With Resolved Recurrent Decelerations
Description	Number of patients with resolution of recurrent variable or recurrent late decelerations within 60 minutes of randomization
Time Frame	60 minutes after randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Oxygen	Oxygen
Arm/Group Description	Room air Room air	10L oxygen by nonrebreather mask 10L Oxygen by nonrebreather mask
Measure Participants	57	57
Count of Participants [Participants]	49 96.1%	43 89.6%

Adverse Events

Time Frame	Until neonate was discharged from hospital. (Up to 1 month after delivery)
Adverse Event Reporting Description	Does not differ from clinicaltrials.gov definitions
Arm/Group Title	Room Air		Oxygen
Arm/Group Description	Room air, no mask		10L oxygen by nonrebreather mask
All Cause Mortality
	Room Air		Oxygen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/57 (0%)
Serious Adverse Events
	Room Air		Oxygen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Room Air		Oxygen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/57 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.