Ignite Creation Date:
2024-05-06 @ 12:37 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03802643
Status:
UNKNOWN
Last Update Posted:
2019-01-14
First Post:
2019-01-03
Brief Title:
Preoxygenation Before General Anesthesia
Sponsor:
University of Parma
Organization:
University of Parma
Study Overview
Official Title:
Assessment of Oxygenation Values Before General Anesthesia in Elective Surgery
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREOX2018
Brief Summary:
Rationale of the study we aim to clarify the question related to still unclear and not univocal response about the protective or unnecessary role of preoxygenation in non-critically ill patients otherwise with no high risk of desaturation undergoing general anesthesia before elective surgery
It will be also necessary differentiate the development of postoperative complications pulmonary cardiovascular neurological surgical due to preoxygenation from the ones related with patient comorbidity intraoperative and surgical causes tube disconnection
Procedure patients informed consent signature for adhesion at the study will be initially requested With their acceptance parameters will be recorded anonymously in the Case Report Form identified by their initials and an alphanumeric code until hospital discharge
The parameters analyzed will be related to
preoperative evaluation about anamnesis health general conditions blood oxygen saturation Sat02 Metabolic Equivalent of Task METs
intraoperative evaluation about oxygenations values recorded beforeduring induction and maintenance of general anesthesia
postoperative evaluation about postoperative complications pulmonary primarily and secondary cardiovascular neurological and surgical based on the medical record
The data wil be transferred on Excel worksheet utilized for descriptive analysis related at every variable By multivariate logistic regression will be evaluated the major factors influencing postoperative pulmonary complications PPCs onset in patients undergoing preoxygenation for elective surgery
It will be also necessary differentiate the development of postoperative complications pulmonary cardiovascular neurological surgical due to preoxygenation from the ones related with patient comorbidity intraoperative and surgical causes tube disconnection
Procedure patients informed consent signature for adhesion at the study will be initially requested With their acceptance parameters will be recorded anonymously in the Case Report Form identified by their initials and an alphanumeric code until hospital discharge
The parameters analyzed will be related to
preoperative evaluation about anamnesis health general conditions blood oxygen saturation Sat02 Metabolic Equivalent of Task METs
intraoperative evaluation about oxygenations values recorded beforeduring induction and maintenance of general anesthesia
postoperative evaluation about postoperative complications pulmonary primarily and secondary cardiovascular neurological and surgical based on the medical record
The data wil be transferred on Excel worksheet utilized for descriptive analysis related at every variable By multivariate logistic regression will be evaluated the major factors influencing postoperative pulmonary complications PPCs onset in patients undergoing preoxygenation for elective surgery
Detailed Description:
Background of the study
Preoxygenation is a widely used technique that improves the safety of endotracheal intubation The procedure is carried out by supplying 100 oxygen FiO2 of 10 before the induction of general anesthesia until both end-tidal oxygen EtO290 and end-tidal N2 EtN25 are reached Both these markers define the efficacy of the procedure As a result the lung oxygen content is increased far beyond normal oxygen consumption by saturating the functional residual capacity with 100 oxygen This allows for a longer safe apnea time ie the time required for oxyhemoglobin saturation to drop below 90 The rate at which oxyhemoglobin saturation drops during apnea indicates the efficiency of the maneuver
This procedure is strongly recommended for all patients undergoing general anesthesia since it lengthens safe laryngoscopy time and grants a wider timeframe to respond to a cannot intubatecannot oxygenate CICO scenario a rare yet life threatening situation It remains unclear whether this should be considered mandatory for non-critically ill and non-obese patients since their oxygen reserves should suffice for the time required to perform endotracheal intubation or regain spontaneous breathing in the event of a CICO scenario Nonetheless the guidelines for the management of endotracheal intubation proposed by the Difficult Airway Society in 2015 United Kingdom state how it is pivotal to preoxygenate every patient before attempting to intubate Several methods of preoxygenation have been validated and compared according to duration of safe apnea time duration of the procedure success rate defined as avoiding manual re-ventilation and patient tolerance The choice between these techniques is based on patient characteristics age sex Body Mass Index American Society of Anesthesiologist score Cormack-Lehane grade and Glasgow Coma Scale settings eg operating room Intensive Care Unit emergency situations equipment and anesthesiologists preferences The two standard approaches are six deep breaths in 1 min and tidal volume breathing for three to 5 min both at 100 inspired oxygen via a face mask
The main side effect of preoxygenation is absorption atelectasis that occurs when delivering 100 inspired oxygen This can be avoided using a lower inspired oxygen concentration 90 positive pressure techniques andor recruitment maneuvers post-endotracheal intubation Due to the short duration of the procedure the production of reactive oxygen species and cardiovascular responses are minimal and should not prevent routine preoxygenation
Preoxygenation is a widely used technique that improves the safety of endotracheal intubation The procedure is carried out by supplying 100 oxygen FiO2 of 10 before the induction of general anesthesia until both end-tidal oxygen EtO290 and end-tidal N2 EtN25 are reached Both these markers define the efficacy of the procedure As a result the lung oxygen content is increased far beyond normal oxygen consumption by saturating the functional residual capacity with 100 oxygen This allows for a longer safe apnea time ie the time required for oxyhemoglobin saturation to drop below 90 The rate at which oxyhemoglobin saturation drops during apnea indicates the efficiency of the maneuver
This procedure is strongly recommended for all patients undergoing general anesthesia since it lengthens safe laryngoscopy time and grants a wider timeframe to respond to a cannot intubatecannot oxygenate CICO scenario a rare yet life threatening situation It remains unclear whether this should be considered mandatory for non-critically ill and non-obese patients since their oxygen reserves should suffice for the time required to perform endotracheal intubation or regain spontaneous breathing in the event of a CICO scenario Nonetheless the guidelines for the management of endotracheal intubation proposed by the Difficult Airway Society in 2015 United Kingdom state how it is pivotal to preoxygenate every patient before attempting to intubate Several methods of preoxygenation have been validated and compared according to duration of safe apnea time duration of the procedure success rate defined as avoiding manual re-ventilation and patient tolerance The choice between these techniques is based on patient characteristics age sex Body Mass Index American Society of Anesthesiologist score Cormack-Lehane grade and Glasgow Coma Scale settings eg operating room Intensive Care Unit emergency situations equipment and anesthesiologists preferences The two standard approaches are six deep breaths in 1 min and tidal volume breathing for three to 5 min both at 100 inspired oxygen via a face mask
The main side effect of preoxygenation is absorption atelectasis that occurs when delivering 100 inspired oxygen This can be avoided using a lower inspired oxygen concentration 90 positive pressure techniques andor recruitment maneuvers post-endotracheal intubation Due to the short duration of the procedure the production of reactive oxygen species and cardiovascular responses are minimal and should not prevent routine preoxygenation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None