An interventional study of HFNO-Assisted Deep Extubation and Conventional Awake Extubation in Deep Tracheal Extubation, sponsored by Fayoum University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Fayoum University · Not applicable, Interventional, and Supportive care
This prospective, randomized controlled trial aims to compare two methods of tracheal extubation after general anesthesia in adults with morbid obesity undergoing elective laparoscopic surgery.
A total of 120 patients will be randomly assigned to one of two groups. In the first group, the breathing tube will be removed while the patient remains deeply anesthetized, followed immediately by heated and humidified high-flow nasal oxygen (HFNO). Patients will then be allowed to awaken without unnecessary stimulation. In the second group, the breathing tube will be removed after the patient is fully awake, followed by conventional oxygen therapy through a face mask.
The primary objective is to determine whether HFNO-assisted deep extubation reduces the incidence of coughing during the first 15 minutes after extubation compared with conventional awake extubation.
The study will also assess respiratory complications, the need for airway interventions, hemodynamic changes, recovery times, and adverse events associated with the two extubation approaches.
The findings may help inform airway management strategies during recovery from general anesthesia in patients with morbid obesity.
Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients scheduled for elective laparoscopic surgery .
Exclusion Criteria:
Patients with severe obstructive sleep apnea (OSA) on home CPAP/BiPAP therapy who cannot tolerate nasal cannula delivery systems.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients allocated to this group will undergo tracheal extubation while deeply anesthetized, after confirmation of adequate spontaneous ventilation and neuromuscular recovery (train-of-four ratio ≥0.9). Immediately after extubation, heated and humidified high-flow nasal oxygen (HFNO) will be administered at an initial flow rate of 40 L/min, adjustable up to 60 L/min as clinically indicated. Oxygen concentration will be titrated to maintain SpO₂ ≥92%. HFNO will be continued for 60 minutes in the post-anesthesia care unit (PACU).
Procedure: HFNO-Assisted Deep Extubation
Patients allocated to this group will undergo conventional awake tracheal extubation after discontinuation of general anesthesia, once they regain consciousness, respond to verbal commands, and meet standard extubation criteria, including adequate spontaneous ventilation and neuromuscular recovery (train-of-four ratio ≥0.9). Following extubation, supplemental oxygen will be administered through a simple face mask at 8-10 L/min for 60 minutes in the post-anesthesia care unit (PACU).
Procedure: Conventional Awake Extubation
At the end of surgery, following adequate recovery from neuromuscular blockade (train-of-four ratio ≥0.9) and confirmation of adequate spontaneous ventilation, the endotracheal tube will be removed while the patient remains deeply anesthetized (end-tidal sevoflurane concentration ≥1.0 age-adjusted MAC). Immediately after extubation, heated and humidified high-flow nasal oxygen (HFNO) will be administered through nasal cannulae at an initial flow rate of 40 L/min, which may be increased to 60 L/min as clinically indicated. The initial FiO₂ will be 1.0 and subsequently titrated to maintain SpO₂ ≥92%. HFNO will continue for 60 minutes in the post-anesthesia care unit. Unnecessary stimulation during emergence will be avoided.
At the end of surgery, general anesthesia will be discontinued, and tracheal extubation will be performed after the patient regains consciousness, responds to verbal commands, and fulfills standard extubation criteria, including adequate spontaneous ventilation and neuromuscular recovery (train-of-four ratio ≥0.9). Following extubation, supplemental oxygen will be administered via a simple face mask at 8-10 L/min for 60 minutes in the post-anesthesia care unit.
Incidence of Coughing During Extubation and Early Emergence
The proportion of patients experiencing at least one episode of coughing during tracheal extubation or within the first 15 minutes after extubation. Coughing will be recorded as a binary outcome (yes/no) for each participant, and the incidence will be compared between the two study groups.
Time frame: During tracheal extubation and up to 15 minutes post-extubation
Severity of Coughing During Extubation and Early Emergence
Cough severity will be assessed using the Modified Minogue Cough Scale, a four-grade ordinal scale: Grade 1, no coughing; Grade 2, mild coughing; Grade 3, moderate coughing; and Grade 4, severe coughing. Cough severity will be assessed during tracheal extubation and throughout the first 15 minutes after extubation.
Time frame: During tracheal extubation and up to 15 minutes post-extubation
Incidence of Laryngospasm
The proportion of participants who experience laryngospasm during emergence from general anesthesia or within the first 60 minutes after tracheal extubation. Laryngospasm will be recorded as present or absent (yes/no), and any episode will be classified as partial or complete.
Time frame: During emergence and up to 60 minutes after tracheal extubation
Incidence of Breath-Holding or Apnea
The proportion of participants experiencing at least one episode of breath-holding or apnea during emergence from general anesthesia or within the first 60 minutes after tracheal extubation. Events will be recorded as present or absent (yes/no), with the type of respiratory event documented when applicable.
Time frame: During emergence and up to 60 minutes after tracheal extubation
Heart Rate During Emergence and Early Postoperative Recovery
Heart rate (HR), measured in beats per minute (bpm), will be recorded at pre-induction baseline, immediately after tracheal extubation, and at 5, 10, 15, 30, and 60 minutes post-extubation. Heart rate measurements at the predefined time points will be compared between the two study groups.
Time frame: At pre-induction baseline, immediately after tracheal extubation, and at 5, 10, 15, 30, and 60 minutes post-extubation.
Mean Arterial Pressure During Emergence and Early Postoperative Recovery
Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), will be recorded at pre-induction baseline, immediately after tracheal extubation, and at 5, 10, 15, 30, and 60 minutes post-extubation. Mean arterial pressure measurements at the predefined time points will be compared between the two study groups.
Time frame: At pre-induction baseline, immediately after tracheal extubation, and at 5, 10, 15, 30, and 60 minutes post-extubation.
Time From Extubation to Full Orientation
From tracheal extubation until achievement of full orientation, assessed for up to 60 minutes after extubation.
Time frame: From tracheal extubation until full orientation during emergence
Length of Stay in the Post-Anesthesia Care Unit
From admission to the post-anesthesia care unit (PACU) until PACU discharge, assessed for up to 4 hours after admission.
Time frame: From PACU admission to PACU discharge
Incidence of Bronchospasm
The proportion of participants experiencing at least one clinically diagnosed episode of bronchospasm during emergence from general anesthesia or within the first 60 minutes after tracheal extubation. Bronchospasm will be recorded as present or absent (yes/no).
Time frame: During emergence and up to 60 minutes after tracheal extubation
No study locations are listed for this record.
Plan to share: No — There is currently no plan to share individual participant data with external researchers. Study findings will be disseminated through scientific publications and presentations.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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