Effect of Coughing on Oxygenation in the Post Anaesthetic Care Unit
Adverse Effect of Unspecified General Anesthetics
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Study of the Effect of Coughing on Emergence From Anaesthesia on Oxygenation in the Postanaesthetic Care Unit|
- Change in oxygenation before and after emergence from general anaesthesia [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]Change between intraoperative and postoperative AaDO2 for each patient in relation to the amount of coughing observed on emergence from anaesthesia.
|Study Start Date:||January 2011|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
This is an observational study which hopes to answer the question of whether the amount of coughing that occurs when a patient emerges from anaesthesia has a negative impact on the ability of the lung to transfer oxygen to the blood in the post anaesthetic care unit (PACU). The patients' involvement starts 45 minutes before the anticipated end of surgery when a standard lung recruitment manoevre will be performed. Fifteen minutes later a 2ml blood sample is taken from the arterial catheter which was placed at the beginning of surgery. From this, together with routinely monitored clinical data, the alveolar/arterial oxygen difference (AaDO2) is calculated. The AaDO2 is used as a measure of the degree of impairment of the lung's ability to fully oxygenate the blood. Next, as the patient wakes up from the anaesthesia, an observer (who is not involved in the clinical care of the patient) will record the amount of coughing that occurs. Assessment of coughing will involve recording:
- time spent coughing
- the number of coughs before and after removing the breathing tube Postoperative care will be routine with oxygen given as required. 1 hour after removal of the tracheal tube a second arterial blood sample is taken from the arterial catheter whilst the patient is breathing 40% oxygen and once again the AaDO2 is calculated. Following the second blood sample the subject's involvement with the study ends.
During the operation no stipulations are made regarding the anaesthetic technique to be used, which is left entirely at the discretion of the anaesthetist with clinical responsibility for the patient. In the last 30 minutes of the operation, the patient's artificial ventilation will be with an oxygen concentration of 40% and a set 'positive end expiratory pressure'(PEEP). Other than that, anaesthetists will be free to wake the patient up by their own preferred method. Also, if at any time the responsible anaesthetist feels the adjustment of the ventilation is required in order to act in the patient's best interest, the patient will be removed from the trial.
Data to be recorded will include sex, age, ASA grade (a measurement of the patients' fitness for an anaesthetic), height and weight, whether or not the patient is a smoker and whether the patient has any lung disease. At the end of surgery, the operation performed and its duration will be recorded. These data are required to characterise the population of patients studied and allow comparison with other research.
No medication or perioperative treatment need be withheld or modified as a consequence of the patient being enrolled in the study. There is no requirement for starting any addition medication as a consequence of the study. Patients may withdraw at any time by withdrawal of consent, in which case all subject data will be destroyed and only the fact that consent was withdrawn will be documented. The anaesthetist with clinical responsibility for the patient may withdraw the patient from the study at any time, in which case the reason for withdrawal will be documented on the data collection form and any data collected will be kept until study completion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314287
|St James's University Hospital|
|Leeds, West Yorkshire, United Kingdom, LS9 7TF|
|Principal Investigator:||Andrew B Lumb, MB BS FRCA||Leeds teaching Hospitals NHS Trust|