Lower Oxygen Concentration for Preventing Collapsed Lung
(RESPIRA-EIT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Beth Israel Deaconess Medical Center
Disqualifiers: Morbid obesity, Coronary artery disease, Sleep apnea, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Patients undergoing general anesthesia require mechanical ventilation (artificial delivery of air and oxygen to their lungs). It is well known that during mechanical ventilation so called atelectasis formation occurs. This is a condition characterized by partial or complete collapse of lung tissue that can result in a reduction in oxygen uptake through the lung. A known risk factor for atelectasis formation during mechanical ventilation is the utilization of high oxygen concentration as the oxygen molecules are absorbed in the lung, which then can lead to collapse of the tissue. Despite the proven association standard operating procedure at the end of anesthesia still requires utilization of 100% oxygen. Its justification is the goal to ensure sufficient oxygenation throughout the extubation phase. However, clinical observation doesn't show a lack of oxygenation in this phase but the patient is still exposed to the risk of atelectasis formation.
This study aims to investigate the hypothesis of whether the utilization of reduced oxygen concentration before extubation (70% compared to 100%) reduces atelectasis formation. Patients who participate in this study are randomly (i.e. by chance) assigned to either the control group receiving standard care (100% oxygen at the end of anesthesia), or the intervention group receiving 70% oxygen. Of note, this is still 3 times as much as when breathing "standard" room air, which has 21% oxygen. During the intervention, parameters such as the oxygen content in the blood (oxygen saturation, SpO2), heart rate and blood pressure are recorded and atelectasis formation is measured using a technique called electrical impedance tomography (EIT). EIT measurements are performed at designated timepoints during the procedure. Anesthesia care providers are asked to document procedural, patient and ventilator data in a questionnaire. Secondary outcomes are the homogeneity and distribution of air measured with EIT, as well as some clinical outcomes including post-extubation desaturation (\<90% SpO2), incidence of re-intubation or non-invasive ventilation and the Post-anesthesia Care Unit (PACU) length of stay.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment involving mechanical ventilation with reduced oxygen concentration for preventing collapsed lung?
Research suggests that while high oxygen levels can be harmful in some conditions, using a lower oxygen concentration during mechanical ventilation may help avoid potential lung damage. This approach aligns with findings that conservative oxygen therapy can be beneficial in managing severe respiratory conditions.
12345Is it safe to use lower oxygen concentrations in clinical trials for preventing collapsed lung?
Using high oxygen concentrations can have harmful effects, especially in certain conditions like chronic obstructive pulmonary disease (COPD) and heart issues. However, short-term use of high oxygen levels in controlled settings, like mechanical ventilation, has not shown injury in some studies. It's important to follow guidelines to avoid excessive oxygen use.
12367How does the treatment of ventilating with 70% oxygen concentration differ from other treatments for preventing collapsed lung?
This treatment is unique because it uses a lower oxygen concentration (70%) compared to the more common practice of using higher concentrations, like 100%, in mechanical ventilation. This approach aims to prevent lung injury that can occur with high oxygen levels while still providing sufficient oxygen to the patient.
1891011Eligibility Criteria
This trial is for adults over 18 who are having elective surgery with general anesthesia and endotracheal intubation, lasting between 1-5 hours. They must consent to participate in the study.Inclusion Criteria
I am 18 years old or older.
I have given my consent to participate.
I am scheduled for a surgery that requires being put to sleep and a breathing tube.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 day
1 visit (in-person)
Intervention
Participants are randomly assigned to receive either 70% or 100% oxygen concentration during the washout phase before extubation. EIT measurements and other parameters are recorded.
1 day
1 visit (in-person)
Postoperative Monitoring
Participants are monitored in the PACU for 60 minutes post-extubation, with EIT measurements and SpO2 levels recorded.
1-2 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including re-intubation or non-invasive ventilation needs within 7 days.
7 days
Participant Groups
The study tests if using a lower oxygen concentration (70%) before removing a patient's breathing tube reduces lung collapse compared to the standard high oxygen level (100%). Patients are randomly assigned to one of these two approaches.
2Treatment groups
Active Control
Group I: Control groupActive Control1 Intervention
Ventilating the patient with 100% oxygen concentration during the wash out phase, before extubation
Group II: Intervention groupActive Control1 Intervention
Ventilating the patient with 70% oxygen concentration during the wash out phase, before extubation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical SchoolBoston, MA
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Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical CenterLead Sponsor
References
Short-term administration of a high oxygen concentration is not injurious in an ex-vivo rabbit model of ventilator-induced lung injury. [2014]Mechanical ventilation and administration of a high oxygen concentration are simultaneously used in the management of respiratory failure. We conducted this study to evaluate the effect of a high inspired oxygen concentration on ventilator-induced lung injury.
[Oxygen therapy in emergency and intensive care medicine]. [2021]Oxygen treatment is being widely used in intensive care and emergency medicine and is required to maintain aerobic metabolism. It may be administered by nasal cannula, face mask, high-flow therapy, and by ventilation. Under clinical circumstances, blood oxygen concentration is not relevantly increased above a partial pressure of 80 mmHg. Although oxygen therapy is often life-saving, it has recently been shown that its indiscriminate administration may increase morbidity and mortality, presumably due to a formation of reactive-oxygen species.For ventilated critically ill patients the optimal targets need to be further defined but harm has been shown for mild hyperoxia. For patients with acute exacerbation of chronic obstructive lung disease hyperoxia may lead to an increase of hypercarbia. Hyperoxia may increase myocardial necrosis in myocardial infarction. For patients with stroke, data do not show any benefit or harm from oxygen administration.On the other hand, hyperoxia shall be used for treatment in patients with cardiac arrest until return of spontaneous circulation and in patients with carbon monoxide poisoning.For other conditions, no benefit has been shown for hyperoxia, but undoubtedly, hypoxemia must be avoided, as well. Therefore, a normoxic oxygenation strategy should be employed. The optimal oxygenation targets for distinct conditions need to be further defined.
Evaluation of inpatient oxygen therapy in hypercapnic chronic obstructive pulmonary disease. [2021]High concentration oxygen therapy in hypercapnic chronic obstructive pulmonary disease (COPD) is associated with increased mortality. In ward-based patients with acute exacerbation of COPD and hypercapnia, this study examines oxygen prescription and the association between high concentration oxygen therapy and adverse outcome.
Oxygen Targets During Mechanical Ventilation in the ICU: A Systematic Review and Meta-Analysis. [2022]Patients admitted to intensive care often require treatment with invasive mechanical ventilation and high concentrations of oxygen. Mechanical ventilation can cause acute lung injury that may be exacerbated by oxygen therapy. Uncertainty remains about which oxygen therapy targets result in the best clinical outcomes for these patients. This review aims to determine whether higher or lower oxygenation targets are beneficial for mechanically ventilated adult patients.
[Observation of the curative effect of conservative oxygen therapy in mechanical ventilation of patients with severe pneumonia]. [2021]To compare the effects of conservative oxygen therapy and conventional oxygen therapy on the efficacy and prognosis of mechanical ventilation support in patients with severe pneumonia.
[Oxygen toxicity in acute care settings]. [2019]Oxygen therapy is widespread in acute care settings as adequate oxygen supplementation is essential in case of hypoxemia. Excessive oxygen supplementation has several unrecognized deleterious effects. This article reviews the deleterious effects of hyperoxemia and sums up the actual recommendations for safe oxygen supplementation.
'Safe oxygen' in acute asthma: prospective trial using 35% Ventimask prior to admission. [2019]There is still some uncertainty as to the best inspired oxygen concentration to use in the treatment of acute asthma before measurement of arterial blood gases can be made. In the absence of published data, we report a prospective study in which 35% oxygen was the initial therapy given to patients with moderate to severe asthma, and arterial blood gases were taken to assess the adequacy of oxygenation and the safety of this method. Forty-five episodes were analyzed and a wide range of PaO2 was observed (8.8-21.3 kPa 66-160 mmHg). No relationship was shown between PaCO2 and either PaO2 or duration of oxygen treatment. It was concluded that 35% oxygen given in acute asthma is both safe and probably adequate. A lesser concentration of oxygen could expose asthmatics to an unacceptable risk of significant hypoxaemia.
Controlled oxygen therapy at 60% concentration. Why and how. [2019]In a number of circumstances pulmonary function is so disturbed that inspired oxygen concentrations of about 60% are needed to combat arterial hypoxaemia. Rational therapy requires that the inspired concentration be controlled and not vary with the patient's breathing. An exploration of the interaction between gas flow, ventilation, breathing pattern, and mask volume shows that a mask of 300 ml volume supplied with a flow of 30 1/min (15 1 O2, 15 1 air) can meet the need.
Randomised controlled trial of high concentration versus titrated oxygen therapy in severe exacerbations of asthma. [2013]The effect on Paco2 of high concentration oxygen therapy when administered to patients with severe exacerbations of asthma is uncertain.
[Oxygen therapy with an oxygen concentrator]. [2008]An account is given of the employment of an O2 concentrator (De VO2 955) in chronic bronchopneumopaths with respiratory insufficiency and pulmonary hypertension. An assessment was made of the gas supply modalities, particularly with Venturi masks. In patients with normal or low ventilation, 24% and 28% FiO2 masks gave suitable results, whereas those with a higher concentration were unusable, since the present FiO2 value was not reached. This was probably due to the fact that there is a fall in O2 concentration at high low flow rates, and as a result of an insufficient Venturi effect.
Uses of oxygen in the treatment of acute respiratory failure secondary to obstructive lung disease. [2016]Breathing 100% O2 is a way of slowing breathing rate, decompressing hyperinflated, low VA/Q lung units, reducing the FRC and allowing the patient with COPD in acute respiratory failure to breath at a more comfortable lung volume and with a higher tidal volume. This should also improve the efficiency of breathing, increasing the fractional turnover of alveolar gas. Simultaneously O2 protects the brain, heart and other organs from hypoxic injury. Breathing 100% O2 provides the major therapeutic approach for rapidly reversing the pathophysiological cycle of impaired respiratory mechanics which threatens the life of the patient in acute respiratory failure. It is a therapeutic approach which might be employed in the tachypnoeic patient in acute respiratory distress, before initiating airway intubation and mechanical ventilation. This provides the physician with time to allow other mechanisms of bronchodilating the patient to be started, and for the need of a more aggressive approach to airway management to be evaluated.