Patients in intensive care units (ICUs) frequently require mechanical ventilation, with approximately half needing invasive ventilation through an orotracheal tube. For these patients, gastric tube (GT) insertion is routinely performed to administer nutrition and medications or to drain gastric contents. The insertion route (oral or nasal) may affect the incidence of ventilator-associated pneumonia (VAP), a significant ICU care complication. This study aims to compare the impact of oral versus nasal GT insertion on the incidence of VAP in intubated ICU patients.
The SONG trial (NCT 05915663) is a multicentre, open-label, two-period, two-intervention, cluster randomised crossover superiority trial. 16 French ICUs will participate. ICUs will be randomised to periods of nasogastric or orogastric tube placement. The trial includes a practice standardisation period, followed by two 12-month inclusion periods separated by a monitoring and washout period. The primary endpoint is the incidence rate of VAP at day 28, confirmed by three independent physicians. Secondary endpoints include the ease of GT insertion, measured by the number of attempts.
This study received approval from a central ethical review board on 12 April 2024 (CPP Sud-est VI, registration number 23.00943.000175). Patients are included after informed consent or, when not possible, from next of kin. If none are available, the investigator will proceed with emergency inclusion, following French law. When consent is initially obtained from the next of kin or through emergency inclusion, the investigator will seek consent from the patient as soon as possible. Data will be anonymised and patient confidentiality maintained. Results will be published in peer-reviewed journals and presented at scientific meetings.
To understand healthcare professionals’ and patients’ views and experiences of septoplasty and medical management (ie, nasal steroid and saline sprays) for nasal obstruction.
Nested qualitative study as part of the Nasal Airway Obstruction Study (NAIROS) trial. We used in-depth interviews to develop a coding framework based on thematic analysis.
NAIROS was a trial based in the UK from January 2018 to December 2020 that aimed to compare the effectiveness of septoplasty versus medical management.
We purposively sampled and interviewed 14 healthcare professionals (surgeons, research nurses) and 31 patients involved in the NAIROS trial across 14 UK hospital sites.
In usual practice, surgeons’ decisions regarding treatment for nasal obstruction are based on a complex assessment of patients’ symptoms, history and anatomy. Surgeons viewed septoplasty as a complex although routine operation, which is not guaranteed to improve symptoms of nasal obstruction. Some patients saw septoplasty, intuitively, as a ‘fix’ for a bent septum, whereas others were keen to avoid surgery if possible. Healthcare professionals welcomed the increased use of standard measurements if these were shown to provide a reliable guide to patient outcomes. However, they felt that it was important to retain an element of clinical judgement. Despite generally good outcomes from septoplasty, some patients still felt they had received little to no benefit from the operation. Patients also reported being underprepared for postsurgery recovery. Experiences were more varied with medical management, with some experiencing symptom improvement, but others discontinuing treatment due to difficulty or pain using the sprays, or perceived ineffectiveness. Remembering to use the sprays could be perceived as burdensome, although most patients were able to incorporate this into their daily routines.
Our qualitative study demonstrated varied individual experiences among patients undergoing septoplasty and medical management. Surgeons welcomed more standard measurements to guide decision-making for septoplasty. For patients, better information about treatment mechanisms, treatment delivery and aftercare, and the development of decision support tools would enable shared decision-making and help to provide optimal patient experience of the treatments.
This study aims to inform the development of a patient-reported symptom questionnaire for head and neck cancer and outline the requirements for a patient-reported symptom-based risk stratification system. The study objectives are to explore how clinicians ask questions and decide subsequent steps for patients referred with suspected head and neck cancer; the language patients and clinicians use to describe symptoms; how clinicians reassure and discharge low-risk patients; and identify clinician and patient experiences of the head and neck cancer diagnostic pathway and their views on a novel diagnostic pathway using patient-reported symptom-based risk stratification.
The study employed qualitative methods including observation and recordings of clinic consultations and semistructured interviews with clinicians and patients. Analysis proceeded concurrently with data collection using a rapid qualitative analysis approach.
Three acute UK National Health Service Trusts with variation in service delivery models. Data collection took place between April and October 2023.
One hundred and fifty-six adults referred for suspected head and neck cancer, and 21 clinicians from different subspecialties were recruited. A subset of recruited patients (n=16) and clinicians (n=13) were interviewed. One observation of a general head and neck clinic was conducted.
The findings highlight types of symptoms and the language used by patients and clinicians to describe these symptoms in clinic consultations. During interviews, patients described the need for in-person support and human clinical decision-making, an accessible system for reporting their symptoms and reassurance regarding the security of patient data. Clinicians discussed the need for risk scores to be sufficiently validated to be trusted, the potential clinical usefulness of a risk score-based system, for example, to support triage by discriminating symptoms, and accessibility for patients. The observation highlighted inconsistent and sometimes unclear referral information and the limited time clinicians have to read referral information.
The findings have implications for the development of a patient-reported symptom-based risk stratification system. As well as ensuring patients can understand the language used, it will be important to consider how their emotional needs can be met. The findings also have wider implications for understanding the impact of language on emotionally evocative healthcare interactions.