Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03600181 |
Other study ID # |
RC18_0181 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 11, 2019 |
Est. completion date |
July 22, 2020 |
Study information
Verified date |
May 2021 |
Source |
Nantes University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Intubation of patients in the intensive care unit (ICU) carries a risk of potentially severe
complications, including cardiac arrest. Hypoxemia is common in ICU patients requiring
intubation, which must be performed rapidly to avoid aspiration, since the patient is usually
not in the fasted state. Studies have assessed interventions designed to improve intubation
success rates, such as routine neuromuscular blockade. Care bundles combined with training on
simulators have improved the safety of intubation. Nevertheless, intubation in the ICU still
carries higher morbidity and mortality rates compared to intubation in the operating room.
Preoxygenation is a cornerstone of safety for intubation in the ICU. Several recent trials
have investigated different devices (non-rebreather mask, non-invasive ventilation, high flow
nasal cannula, bag valve mask) with conflicting results. A main reason for those results is
that efficiency of the preoxygenation period cannot be evaluated in the ICU in opposite to
the operating room: gas monitoring are not available in ICU and even if it was the case, high
flow demand from the patient, and agitation will make it inefficient. Additionally,
desaturation is frequent (from 10% up to 50%) during intubation in ICU and lead to morbidity
and mortality; so anticipation of desaturation is a major concern for ICU's physician because
it's impacting care (face mask ventilation, early insertion of subglottic device). The oxygen
reserve index (ORI) is a new parameter for monitoring oxygen reserve non-invasively.
In this context, the investigators purpose to analyze efficiency of preoxygenation and time
allowed by ORI for medical interventions before hypoxemia during intubation in the ICU in a
pilot observational study in our medical ICU in a university hospital.
Description:
*Severe hypoxaemia is the most common serious adverse event during endotracheal intubation
(ETI) in patients admitted to the intensive care unit (ICU), consistently reported around
25%. Preoxygenation is universally recommended as a risk-minimisation measure. While
effective in the operating room, preoxygenation is more complex in critically ill patients,
most notably those with acute hypoxic respiratory failure, as the low functional residual
capacity (FRC) carries a risk of denitrogenation being confined to the healthy lung
parenchyma, so that the FeO2 (Fraction of expired oxygen) no longer reflects the partial
pressure of oxygen in arterial blood (PaO2). In these patients, 8 minutes of preoxygenation
using a bag-valve-mask (BVM) device failed to change PaO2 levels noticeably. Increasing the
BVM time was unhelpful, as the increase in PaO2 achieved in some patients was offset by
decreases in others.
Non-invasive ventilation (NIV) has theoretical advantages for preoxygenation and has been
shown to provide higher PaO2 values in hypoxic patients compared to a non-rebreathing (NRB)
mask. However, use of NIV has several contraindications including consciousness alterations
and agitation, and drawbacks such as gastric distension.
Apnoeic oxygenation which has been updated is a method consisting in continued oxygenation
during laryngoscopy to extend the safe apnoea time. High-flow nasal oxygen (HFNO) therapy
ensuring high and stable FiO2 (fraction of inspired oxygen) values by delivering oxygen flows
above 60 L/min is another innovation shown to improve oxygenation in hypoxaemic patients. The
effect of HFNO for preoxygenation, however, is less clear, as one study suggested benefits
vs. NRB mask in patients with moderate hypoxaemia but another found no significant difference
vs. BVM in patients with PaO2/FiO2 ratios below 200. No large randomised trial has compared
preoxygenation methods. The latest recommendations of the Difficult Airway Society suggest
than "In hypoxaemic patients, CPAP (continuous positive airway pressure) and non-invasive
ventilation (NIV) may be beneficial."
As preoxygenation is a cornerstone of safety for intubation in the ICU, several recent trials
have investigated different devices (non-rebreather mask, non-invasive ventilation, high flow
nasal cannula, bag valve mask) with conflicting results. A main reason for those results is
that efficiency of the preoxygenation period cannot be evaluated in the ICU in opposite to
the operating room : gas monitoring are not available in ICU and even if it was the case,
high flow demand from the patient, and agitation will make it inefficient. Additionally,
desaturation is frequent (from 10% up to 50%) during intubation in ICU and lead to morbidity
and mortality; so anticipation of desaturation is a major concern for ICU's physician because
it's impacting care (face mask ventilation, early insertion of subglottic device).
The oxygen reserve index (ORI) (Masimo Corp., Irvine, CA, USA) is a new parameter that
indicates real-time oxygenation reserve status in mild hyperoxemia range [partial pressure of
oxygen (PaO2) of about 100-200 mmHg). ORI can be measured non-invasively by applying an
exclusive sensor on a finger; the ORI is a nondimensional index that changes according to the
oxygenation reserve status of the patient. It uses a value range of 0.00-1.00.
In this context, the investigators purpose to analyze efficiency of preoxygenation and time
allowed by ORI for medical interventions before hypoxemia during intubation in the ICU in a
pilot observational study in our medical ICU in a university hospital.
*Study population : Patients admitted in ICU and planned to be intubated. Recruitment will be
done in the Medical ICU of Nantes University Hospital. The study plans to include 50 patients
admitted to intensive care and requiring a tracheal intubation procedure, after the provision
of the informational letter and collection of non-opposition from the patient or responsible
party, or through the emergency inclusion process. In the latter two cases, the
non-opposition of the patient will be collected retrospectively after reading the
informational letter.
*Design and conduct of the study : In each case, after intubation decision was made and
patient consent, a non-invasive sensor capable of measuring ORI (Rainbow® Sensor, R2-25,
Revision L, Masimo Corp.) will be applied to the third or fourth finger on the contralateral
side of the inflatable cuff for non-invasive blood pressure monitoring. The sensor will be
shield to be protected from exposure to light. SpO2 and ORI values, displayed on Root with
Radical7 will be recorded each 2 seconds and then will be transferred to a laptop.
Participation in the study will end in case of secondary opposition of the patient.
Patient leaving the protocol will continue the usual follow-up.
*Data management and patient identification : Data collection for each person participating
in the research is realized with paper case report form (CRF). Each person responsible for
the filling of the CRF (investigator, clinical research assistant ...) will have to be
identified in the table of delegations of responsibilities of the center (see investigator's
file).
Entering, viewing or modifying data will only be possible via the CRF. The structure of the
database will be approved by the person responsible for the research, and will be implemented
in conformity with the protocol and the relevant regulations.
Medical data for each patient can only be forwarded to the affiliated organization of the
person responsible for research or any person duly authorized by him in conditions ensuring
their confidentiality.
The principal investigator and all co-investigators undertake to keep the identities of the
persons who participate in the study confidential by assigning them a code.
This code will be used for all the CRF and all the attached documents (reports of imaging
exams, biology, etc.). It will be the only information which will make it possible to make
the connection with the patient retrospectively. To this end, a correspondence table will be
implemented and kept in the service under the responsibility of the investigator who will be
the only one to have access to this document.
Sending a person's data for research will hence be possible only provided this code system
has been applied; the presentation of the research results must exclude any direct or
indirect identification.
No nominative data will be collected during this research. The coding rule is the following:
1st letter of first name + first letter of surname + month and year of birth, Inclusion
number.
The documents will be archived under the name of the study in the facilities of the
multipurpose ICU of CHU Nantes until the end of the period of practical utility.
These documents are as follows: Protocols and annexes, possible amendments ; Information
notices ; Individual data (authenticated copies of raw data) ; Follow-up documents ;
Statistical analyses ; Final report of the study.
At the end of the period of practical use, all documents to be archived, as defined in the
classification process and document archiving related to CHU Nantes biomedical research, will
be transferred to the archive site (CHU Nantes) and will be placed under the responsibility
of the institution responsible for research for 15 years following the end of the study in
accordance with the institutional practices.
No displacement or destruction can occur without the consent of the institution responsible
for the research. After 15 years, the institution responsible for the research will be
consulted for destruction. All data, documents and reports may be subject to audit or
inspection.
*Statistics : The protocol falls within the scope of the MR003 (reference methodology 003),
which conforms to Nantes University Hospital.
Qualitative data will be described in frequency and percentage. Quantitative data will be
described using mean, standard deviation, median, and extreme values. All tests will be
bilateral, and the level of significance is 0.05.
Stata statistical software (Release 13; StataCorp LP, College Station, TX) will be used.
Statistical justification of the number of inclusions : Duration before drop of SpO2 was
approximately 60 seconds +/- 30 seconds (data from Lascarrou JAMA (Journal of the American
Medical Association) 2017 and Miguel-Montanes Critical Care Medicine 2015). Assuming that the
ORI drop occurs 30 seconds before SpO2 drop, the investigators would like to estimate the
average delay between these two drops with 95% confidence interval, with a precision to 10
seconds. Assuming a standard deviation equal to 30 seconds, 35 patients will be necessary.
According to Szmuk, only 72% patients will be analyzed so the investigators decide to include
50 patients.
All statistical tests will be performed with a significance level of 5%. No imputation will
be realized for this observational study.
*Safety : No adverse event or reaction can be associated with this study insofar as it
consists on a non-interventional study with no impact on care.