No registrations found.
ID
Source
Brief title
Health condition
Atelectasis, upper respiratory tract infections
Sponsors and support
Intervention
Outcome measures
Primary outcome
Atelectasis after procedural sedartion
Secondary outcome
Signs and symptoms of upper respiratory tract infections
Background summary
Background Procedural sedation is used to enable patients to tolerate uncomfortable or painful diagnostic or therapeutic, non-surgical procedures. Practitioners use medication for PSA that can cause cardiorespiratory compromise. A well known side effect of sedatives and opioids is depression of the respiratory system. Hypothetically this depression can result in atelectasis formation and/or respiratory problems, especially if the procedure is protracted. No evidence is available concerning the relationship between the duration of procedural sedation and the formation of atelectasis and/or respiratory symptoms. This study investigates this relationship via a non-invasive method using only proprietary procedures for PSA and a short, 5 question telephonical questionnaire.
• Main research question
Is longer duration of procedures under PSA associated with an increased incidence of atelectasis formation and/or respiratory symptoms
• Design (including population, confounders/outcomes)
Prospective non-randomized trial. Population: patients scheduled for a procedure under PSA with the potential to have a procedure duration of more than 2 hours. Exclusion criteria: previous lung surgery, ASA status 4, COPD GOLD class III or IV, SpO2 on room air (pre-procedural) of <97%. Confounders: obesity, airway compromise, need for an FiO2 of more than 50% during the procedure.
• Expected results
null-hypothesis: There is no relationship between the duration of the procedure under PSA and the incidence of atelectasis and/or respiratory symptoms.
Study objective
There is no relationship between the duration of the procedure under PSA and the incidence of atelectasis and/or respiratory symptoms.
Study design
Post-procedural sedation and 7 days post sedation procedure
Inclusion criteria
o Planned for procedure under PSA performed by the department of anesthesiology
o Passed screening for PSA
o Procedure will potentially last longer than 2 hours
o Procedure performed in prone position
o SpO2 on room air pre-procedurally > 96%
Exclusion criteria
o Procedure with prolonged esophageal or bronchial manipulation
o ASA status IV
o COPD Gold 3-4
o previous lung surgery
o use of CPAP for OSAS
o Use of FiO2 > 50% during procedure
o Use of endotracheal intubation during procedure
o Use of Optiflow during procedure
o need for additional bolusses of esketamine during the procedure
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8320 |
| Other | METC-UMCG : METC2019/556 |