Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKocaeli City Hospital

About this trial

Perioperative airway/respiratory complications are a major driver of morbidity and mortality. While UK audits NAP4 and NAP7 extensively examined major critical events (e.g., cardiac arrest), prospective standardized data on acute, more frequent extubation-phase complications-such as desaturation, laryngospasm, obstruction, bronchospasm, and aspiration-remain scarce. Off-hours procedures carry additional risks related to increased workload, reduced senior supervision, and clinician fatigue, though current evidence is inconclusive and requires further human-factors research using validated tools like the Karolinska Sleepiness Scale (KSS). This prospective cohort study at Kocaeli City Hospital aims to compare the incidence of acute airway/respiratory complications and intervention requirements during extubation and the first 30 minutes post-extubation between on-hours (08:00-16:00) and off-hours (\>16:00). Notably, this will be the first prospective observational study to specifically test NAP7's off-hours risk findings at the extubation stage, with the goal of strengthening patient safety and guiding institutional quality improvement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients undergoing surgery under regional anaesthesia or sedation without endotracheal intubation

Trial population

The study population comprises adult patients (aged ≥ 18 years, with no upper age limit) undergoing either elective or emergency surgery under general anaesthesia with endotracheal intubation at Kocaeli City Hospital, a tertiary referral centre in Turkey. Eligible participants are those in whom tracheal extubation is planned in the operating theatre or in the post-anaesthesia care unit (PACU). The population includes both American Society of Anesthesiologists (ASA) Class I-V patients, reflecting the full spectrum of surgical acuity and comorbidity burden encountered in routine clinical practice. Patients undergoing regional anaesthesia or sedation without intubation, those with a pre-existing tracheostomy, patients transferred intubated to the intensive care unit postoperatively, and those undergoing cardiothoracic surgery involving cardiopulmonary bypass are excluded. Additionally, patients requiring emergency airway management outside the operating theatre, those with a known or susp

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Extubation

    Procedure/Surgery

    An extubation attempt is the planned, deliberate removal of the endotracheal tube from the patient's trachea, beginning with preparatory manoeuvres (such as oropharyngeal suctioning and cuff deflation) and ending with the complete withdrawal of the tube and establishment of a patent native airway with adequate spontaneous breathing.

  • Survey/Questionnaire Administration

    Other intervention

    Description: The Karolinska Sleepiness Scale (KSS), a validated 9-point Likert scale (1 = extremely alert, 9 = very sleepy, fighting sleep), will be administered to the attending anaesthetist responsible for performing the extubation immediately prior to the extubation procedure. This assessment is performed to objectively quantify the clinician's subjective level of sleepiness and fatigue at the time of extubation. The KSS score will be recorded as a predictor/exposure variable to evaluate the association between anaesthetist fatigue and the occurrence of acute airway and respiratory complications during extubation. This assessment is applied uniformly across both study groups (on-hours and off-hours extubations).

Treatment groups

2,640 Participants
are divided into 2 treatment groups
Group A: On-Hours2 interventions
Group B: Off-Hours2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Desaturation During Extubation

Description: The occurrence of desaturation during the extubation procedure itself, defined as a peripheral oxygen saturation (SpO₂) \< 90% lasting for ≥ 30 seconds (or a ≥ 5% decrease from baseline in patients with pre-existing hypoxaemia), measured from the initiation of extubation manoeuvres (cuff deflation and suctioning) until the complete withdrawal of the endotracheal tube. Time Frame: Desaturation occurring during the extubation attempt and within the first 30 minutes post-extubation.

Time frame
30 min. after extubation

Secondary outcomes

1

Other acute airway/respiratory complications

(laryngospasm, airway obstruction, bronchospasm, aspiration, apnoea, haemodynamic instability, arrhythmias, unplanned reintubation, surgical airway).

Time frame
30 min. after extubation

Other outcomes

1

Intervention requirement by type

(simple airway manoeuvres, bag-mask ventilation, pharmacological agents, reintubation, surgical airway)

Time frame
30 min. after extubation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.