Intraoperative ComplicationsNCT03665259
Lower Inspiratory Oxygen Fraction for Preoxygenation
A study testing Pure oxygen group and Lower oxygen group in people with Intraoperative Complications and Respiratory Complication, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
During the induction period of general anesthesia, surgical patients are inevitably experienced a short period of apnea for endotracheal intubation or other airway manipulation. In order to minimize the risks of hypoxemia during the establishment of artificial airway, pure oxygen (FiO2=100%) is commonly applied to the… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Intraoperative Complications, Respiratory Complication, Oxygen Toxicity
- What is being tested?
- Pure oxygen group and Lower oxygen group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient who is scheduled for an elective surgery and required for general anesthesia with endotracheal intubation.
- Age of the patient is between 20 and 65 years old.
- Patient's American Society of Anesthesiologists (ASA) Physical Status is I- III.
Who cannot join
- Patients who:
- Have difficult airway for ventilation or intubation.
- Have severe lung disease (including any acute respiratory infection).
- Had past history of coronary artery disease or myocardial infarction.
- Have severe heart failure (NYHA Fc ≥III).
- Have liver cirrhosis (Child-Pugh's score ≥B).
Show all 14Show fewer
- Have acute or chronic kidney disease (Creatinine ≥2 mg/dl).
- Have severe anemia (hemoglobin ≤8 mg /dl).
- Have a body mass index (BMI) ≥35.
- Are currently pregnant.
- Have inadequate fasting time, intestinal obstruction or severe gastroesophageal reflux.
- Scheduled for an emergency surgery, cardiac surgery, craniotomy, or pulmonary surgery.
- Have mental incapacitant, confusion, dementia, mental retardation, or are unable to complete the consent independently.
- Refuse to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Preoxygenation With Lower Inspiratory Oxygen Fraction During Induction of Anesthesia
During the induction period of general anesthesia, surgical patients are inevitably experienced a short period of apnea for endotracheal intubation or other airway manipulation. In order to minimize the risks of hypoxemia during the establishment of artificial airway, pure oxygen (FiO2=100%) is commonly applied to the patients throughout the preoxygenation and induction period. However, high concentration of oxygen therapy has been shown to result in hyperoxemia and substantial oxygen exposure during perioperative period or critical care. There is currently no clinical evidence indicating that preoxygenation with a lower oxygen partial pressure (such as FiO2=60%) during the induction of anesthesia increases the incidence of hypoxemia or other complications. The findings of this proposed clinical study may provide fundamental evidence for the use of different oxygen concentrations in clinical anesthesia during the induction period, and determine the effects of inspired oxygen concentrations on the general postoperative outcomes during general anesthesia.
Read the detailed description
The administration of 100% oxygen for 3-5 minutes may replace the nitrogen content in the lung cavity (de-nitrogenation) with higher alveolar concentrations of oxygen (greater then 95%). Elevation of oxygen reserve in the lung and oxygen partial pressure in the blood circulation may thus delay the development of hypoxemia (oxygen desaturation; defined as the tissue oxygen saturation below 90%) up to 10 minutes after apnea.
On the other hand, there is currently no clinical evidence indicating that preoxygenation with lower oxygen partial pressures (i.e. FiO2= 50-60%) during the induction of anesthesia increases the incidence of hypoxemia or other complications. Most recently, two elegant large-scale clinical trials reported that the supplement of oxygen to patients with acute myocardial infarction or acute ischemic stroke did not provide any clinically beneficial effects in the prognosis of diseases. The results of these two important trials did not support the routine supplement of oxygen in these acute diseases. In addition, high concentrations of oxygen therapy are potentially deleterious, as oxygen toxicity may result in direct tracheobronchial and alveolar damage, absorption atelectasis (lung tissue collapse) and central nervous system toxicity. In cellular levels, hyperoxia increases the production of reactive oxygen species, such as the superoxide anion, the hydroxyl radical, and hydrogen peroxide, which in turn may cause cellular apoptosis and inflammatory response. Therefore, oxygen therapy in clinical settings has been recognized as a two-edged sword and excessive oxygen supplement should be guided closely for its potential toxicity.
Currently, there is no clinical evidence that supports the routine administration of 100% oxygen prior to intubation is essential or beneficial. In the contrary, it also remains undetermined if lower fractions of inspiratory oxygen during the induction period of anesthesia may attenuate lung injury or other cellular damage derived from the oxygen toxicity. Therefore, the findings of this proposed clinical study may provide fundamental evidence for the use of different oxygen concentrations in clinical anesthesia during the induction period, and determine the effects of inspiratory oxygen concentrations on the general postoperative outcomes after general anesthesia.
This is a randomized, open-label, observer-blind and non-inferiority clinical trial.
The research model of study is two-group parallel interventional study. The control group is preoxygenation with 100% oxygen during the induction phase of anesthesia; the experimental group is preoxygenation with 60% oxygen during the induction phase of anesthesia. The anesthetists in-charge are not blinded to the concentrations of oxygen use during induction of anesthesia, but the persons who collected study data will be unaware of the treatment. Block randomization will be generated using a generator software and the assignment of treatment will be sealed in the envelops.
This study anticipates in enrolling 1500 participants.
- Conditions
- Intraoperative Complications, Respiratory Complication, Oxygen Toxicity, Oxygen Deficiency, Anesthesia
- Being tested
- Pure oxygen group, Lower oxygen group
- Keywords
- Oxygen, Perioperative medicine, General anesthesia, Preoxygenation
- Medical subject headings
- Intraoperative Complications, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure oxygen groupProcedure or surgery
pre-oxygenation with 100% oxygen during induction of anesthesia
Lower oxygen groupProcedure or surgery
Pre-oxygenation with 60% oxygen during induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Pure oxygen group | Active comparator | The patients receive 100% oxygen therapy during the induction phase of induction Receives: Procedure: Pure oxygen group |
| Lower oxygen group | Experimental | The patients received 60% oxygen therapy during the induction phase of induction Receives: Procedure: Lower oxygen group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
The definition of hypoxemia is the measurement of peripheral oxygen saturation (sPO2) lower than < 92%. Induction phase of anesthesia is defined as the time frame from preoxygenation before intravenous administration of anesthetics to successful establishment of an endotracheal tube.
Measured: Within 30 minutes after induction of anesthesia
Secondary outcomes (6)
Development of acute respiratory distress syndrome (ARDS)
ARDS is defined as any calculated PaO2/FiO2 less than 300mmHg with radiographic evidence of bilateral lung infiltration in the absence of left heart failure
Measured: Within 7 days after surgery
Development of atelectasis
Atelectasis is defined as partial or complete collapse of lung lobe(s) on chest radiography
Measured: Within 7 days after surgery
Development of pneumonia
Pneumonia is defined as acute infection of lung parenchyma
Measured: Within 7 days after surgery
Development of surgical site infection (SSI)
SSI is defined as infection arising from surgical incision
Measured: Within 7 days after surgery
Development of severe postoperative pain
Severe postoperative pain is defined as visual analogue scale (VAS) >4 despite of administration of analgesics. VAS is defined as a straight line with the endpoints representing the extreme limits of pain; "no pain at all= 0" and "pain as bad as it could be= 10"
Measured: Within 7 days after surgery
Length of hospital stay (LOS)
LOS is defined as day(s) of hospitalization after surgery
Measured: Within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Nov 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Why it stopped: Significantly increased incidence of primary endpoint in the FiO2 60% group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: pre-oxygenation with 100% oxygen during induction of anesthesia Group 2: pre-oxygenation with 60% oxygen during induction of anesthesia
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen-Fuh Lam, MD, PhD, Principal investigator, E-DA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665259
- Sponsor's protocol ID
- EMRP15107N
- Status last verified
- Sep 2018
- First submitted
- 2 Sep 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoxygenation With Lower Inspiratory Oxygen Fraction During Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT03665259
- Acronym / sponsor ID
- EMRP15107N
- Conditions
- Intraoperative Complications, Respiratory Complication, Oxygen Toxicity, Oxygen Deficiency, Anesthesia
- Keywords
- Oxygen, Perioperative medicine, General anesthesia, Preoxygenation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significantly increased incidence of primary endpoint in the FiO2 60% group
- Enrolment
- 304 participants (actual)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the induction period of general anesthesia, surgical patients are inevitably experienced a short period of apnea for endotracheal intubation or other airway manipulation. In order to minimize the risks of hypoxemia during the establishment of artificial airway, pure oxygen (FiO2=100%) is commonly applied to the patients throughout the preoxygenation and induction period. However, high concentration of oxygen therapy has been shown to result in hyperoxemia and substantial oxygen exposure during perioperative period or critical care. There is currently no clinical evidence indicating that preoxygenation with a lower oxygen partial pressure (such as FiO2=60%) during the induction of anesthesia increases the incidence of hypoxemia or other complications. The findings of this proposed clinical study may provide fundamental evidence for the use of different oxygen concentrations in clinical anesthesia during the induction period, and determine the effects of inspired oxygen concentrations on the general postoperative outcomes during general anesthesia.
Detailed description
The administration of 100% oxygen for 3-5 minutes may replace the nitrogen content in the lung cavity (de-nitrogenation) with higher alveolar concentrations of oxygen (greater then 95%). Elevation of oxygen reserve in the lung and oxygen partial pressure in the blood circulation may thus delay the development of hypoxemia (oxygen desaturation; defined as the tissue oxygen saturation below 90%) up to 10 minutes after apnea.
On the other hand, there is currently no clinical evidence indicating that preoxygenation with lower oxygen partial pressures (i.e. FiO2= 50-60%) during the induction of anesthesia increases the incidence of hypoxemia or other complications. Most recently, two elegant large-scale clinical trials reported that the supplement of oxygen to patients with acute myocardial infarction or acute ischemic stroke did not provide any clinically beneficial effects in the prognosis of diseases. The results of these two important trials did not support the routine supplement of oxygen in these acute diseases. In addition, high concentrations of oxygen therapy are potentially deleterious, as oxygen toxicity may result in direct tracheobronchial and alveolar damage, absorption atelectasis (lung tissue collapse) and central nervous system toxicity. In cellular levels, hyperoxia increases the production of reactive oxygen species, such as the superoxide anion, the hydroxyl radical, and hydrogen peroxide, which in turn may cause cellular apoptosis and inflammatory response. Therefore, oxygen therapy in clinical settings has been recognized as a two-edged sword and excessive oxygen supplement should be guided closely for its potential toxicity.
Currently, there is no clinical evidence that supports the routine administration of 100% oxygen prior to intubation is essential or beneficial. In the contrary, it also remains undetermined if lower fractions of inspiratory oxygen during the induction period of anesthesia may attenuate lung injury or other cellular damage derived from the oxygen toxicity. Therefore, the findings of this proposed clinical study may provide fundamental evidence for the use of different oxygen concentrations in clinical anesthesia during the induction period, and determine the effects of inspiratory oxygen concentrations on the general postoperative outcomes after general anesthesia.
This is a randomized, open-label, observer-blind and non-inferiority clinical trial.
The research model of study is two-group parallel interventional study. The control group is preoxygenation with 100% oxygen during the induction phase of anesthesia; the experimental group is preoxygenation with 60% oxygen during the induction phase of anesthesia. The anesthetists in-charge are not blinded to the concentrations of oxygen use during induction of anesthesia, but the persons who collected study data will be unaware of the treatment. Block randomization will be generated using a generator software and the assignment of treatment will be sealed in the envelops.
This study anticipates in enrolling 1500 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: pre-oxygenation with 100% oxygen during induction of anesthesia Group 2: pre-oxygenation with 60% oxygen during induction of anesthesia
| Arm | Type | Receives |
|---|---|---|
| Pure oxygen group | Active comparator | Procedure: Pure oxygen groupThe patients receive 100% oxygen therapy during the induction phase of induction |
| Lower oxygen group | Experimental | Procedure: Lower oxygen groupThe patients received 60% oxygen therapy during the induction phase of induction |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A patient who is scheduled for an elective surgery and required for general anesthesia with endotracheal intubation.
- Age of the patient is between 20 and 65 years old.
- Patient's American Society of Anesthesiologists (ASA) Physical Status is I- III.
Key exclusion criteria (14 listed)
- Have difficult airway for ventilation or intubation.
- Have severe lung disease (including any acute respiratory infection).
- Had past history of coronary artery disease or myocardial infarction.
- Have severe heart failure (NYHA Fc ≥III).
- Have liver cirrhosis (Child-Pugh's score ≥B).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure oxygen grouppre-oxygenation with 100% oxygen during induction of anesthesia | Procedure or surgery | Pure oxygen group |
| Lower oxygen groupPre-oxygenation with 60% oxygen during induction of anesthesia | Procedure or surgery | Lower oxygen group |
Primary outcome
Incidence of hypoxemia
Time frame: Within 30 minutes after induction of anesthesia
The definition of hypoxemia is the measurement of peripheral oxygen saturation (sPO2) lower than < 92%. Induction phase of anesthesia is defined as the time frame from preoxygenation before intravenous administration of anesthetics to successful establishment of an endotracheal tube.
6 secondary outcomes
Development of acute respiratory distress syndrome (ARDS)
Time frame: Within 7 days after surgery
Development of atelectasis
Time frame: Within 7 days after surgery
Development of pneumonia
Time frame: Within 7 days after surgery
Development of surgical site infection (SSI)
Time frame: Within 7 days after surgery
Development of severe postoperative pain
Time frame: Within 7 days after surgery
Length of hospital stay (LOS)
Time frame: Within 7 days after surgery
Results and safety
The study was stopped early (reason given: Significantly increased incidence of primary endpoint in the FiO2 60% group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen-Fuh Lam, MD, PhD principal investigator
E-DA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pure oxygen group and Lower oxygen group in people with Intraoperative Complications and Respiratory Complication, run by E-DA Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Significantly increased incidence of primary endpoint in the FiO2 60% group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxemia (time frame: Within 30 minutes after induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.