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

NCT07752173 | Recruiting

• 1 other identifier: KSH-2026-89
• Study Type: observational
• Target: 2,640
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extubation Failures; Extubation; Airway Complication of Anaesthesia

Keywords

Extubation; Airway complications; Off-hours; General anaesthesia; Prospective cohort study

Outcome Measures

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.

  30 min. after extubation

Secondary Outcomes (1)

• Other acute airway/respiratory complications

  30 min. after extubation

Other Outcomes (1)

• Intervention requirement by type

  30 min. after extubation

Study Arms (2)

On-Hours

On-hours group: Extubations performed between 08:00 and 16:00 on weekdays (Monday to Friday), excluding public holidays.

Procedure: Extubation; Other: Survey/Questionnaire Administration

Off-Hours

Off-hours group: Extubations performed after 16:00 on weekdays, as well as all extubations performed on weekends and public holidays, regardless of the time of day

Procedure: Extubation; Other: Survey/Questionnaire Administration

Interventions

Extubation PROCEDURE

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.

Off-Hours; On-Hours

Survey/Questionnaire Administration OTHER

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).

Off-Hours; On-Hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• \- Age ≥ 18 years
• Undergoing elective or emergency surgery under general anaesthesia with endotracheal intubation
• Planned tracheal extubation in the operating theatre or post-anaesthesia care unit (PACU)
• Provision of written informed consent (or deferred consent for emergency cases, in accordance with national regulations)

You may not qualify if:

• Patients undergoing surgery under regional anaesthesia or sedation without endotracheal intubation
• Patients with a tracheostomy in situ
• Patients who remain intubated and are transferred to the intensive care unit (ICU) postoperatively
• Patients undergoing cardiothoracic surgery involving cardiopulmonary bypass
• Emergency airway management performed outside the operating theatre (e.g., ICU, emergency department)
• Patients with known or suspected difficult airway requiring awake fibreoptic intubation
• Patients who refuse to provide informed consent or withdraw consent during the study
• Pregnant patients

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmıt, 41001, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Xie Q, Shen Z, Pan M, Li Y, Luo Z, Wang C, Zhao L, Fang Y, Ding X, Teng J, Xu J. Weekend effect on the incidence and outcomes of cardiac surgery associated - acute kidney injury. BMC Cardiovasc Disord. 2023 Oct 27;23(1):524. doi: 10.1186/s12872-023-03431-4.

  PMID: 37891475 BACKGROUND

• Patel MS, Thomas JJ, Aguayo X, Gutmann D, Sarwary SH, Wain M. The Effect of Weekend Surgery on Outcomes of Emergency Laparotomy: Experience at a High Volume District General Hospital. Cureus. 2022 Mar 27;14(3):e23537. doi: 10.7759/cureus.23537. eCollection 2022 Mar.

  PMID: 35494929 BACKGROUND

• Ash-Rafzadeh H, Chambers TJ, Velez FO, Moodie CC, Garrett JR, Fontaine JP, Toloza EM. Effect of Surgical Day of Week on Postoperative Outcomes After Robotic-Assisted Pulmonary Lobectomy. Cureus. 2023 Feb 23;15(2):e35379. doi: 10.7759/cureus.35379. eCollection 2023 Feb.

  PMID: 36846643 BACKGROUND

• Maman D, Steinfeld Y, Berkovich Y. No Weekend Effect in Elective Primary Total Knee Arthroplasty: A Nationwide Analysis of 437,121 U.S. Cases. J Clin Med. 2025 Dec 12;14(24):8816. doi: 10.3390/jcm14248816.

  PMID: 41464718 BACKGROUND

• Cortegiani A, Gregoretti C, Neto AS, Hemmes SNT, Ball L, Canet J, Hiesmayr M, Hollmann MW, Mills GH, Melo MFV, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Schultz MJ, Pelosi P; LAS VEGAS Investigators, the PROVE Network, and the Clinical Trial Network of the European Society of Anaesthesiology. Association between night-time surgery and occurrence of intraoperative adverse events and postoperative pulmonary complications. Br J Anaesth. 2019 Mar;122(3):361-369. doi: 10.1016/j.bja.2018.10.063. Epub 2019 Feb 8.

  PMID: 30770054 BACKGROUND

MeSH Terms

Interventions

Airway Extubation; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mehmet Yilmaz

  Kocaeli City Hospital

  STUDY CHAIR

Central Study Contacts

Ali Mete Temel, MD

CONTACT

+905438465215; metetemel60@hotmail.com

Mehmet Yilmaz, Md

CONTACT

05052174432; drmyilmaz33@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Resident Physician

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)