Trial Outcomes & Findings for Correlation of Nasopharyngeal (NP) and Lower Oesophageal (LO) Temperatures in Ventilated Children (NCT NCT02201628)

Results Overview

Temperature will be measured in the lower oesophagus of a child ventilated with a cuffed Endotracheal Tube (ETT). Readings will be recorded when there is no leak (cuff up) and when there is a clinically determinable, soft, audible leak (cuff down) around the ETT. Simultaneously temperature will also be measured in the nasopharynx. This will occur during general anaesthesia for a procedure that entails the performance of a radiograph (X-Ray) of the chest. The X-Ray will be used by the investigators to confirm correct placement of the temperature probe in the lower third of the oesophagus. We aim to show that the temperature measured in the lower oesophagus is the same or does not significantly differ from the temperature in the nasopharynx, even in the presence of a leak around the ETT. Temperature differences in degrees celsius will be reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

6 months

Results posted on

2023-01-26

Participant Flow

9 were excluded due to incomplete data or insufficient FVL difference between cuff down and cuff up scenarios

Participant milestones

Participant milestones
Measure	Cuff Inflation and Cuff Deflation Groups Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cuff Inflation and Cuff Deflation Groups n=50 Participants Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak
Age, Continuous	2.3 years n=50 Participants
Sex: Female, Male Female	20 Participants n=50 Participants
Sex: Female, Male Male	30 Participants n=50 Participants
Region of Enrollment United Kingdom	50 participants n=50 Participants

PRIMARY outcome

Timeframe: 6 months

Temperature will be measured in the lower oesophagus of a child ventilated with a cuffed Endotracheal Tube (ETT). Readings will be recorded when there is no leak (cuff up) and when there is a clinically determinable, soft, audible leak (cuff down) around the ETT. Simultaneously temperature will also be measured in the nasopharynx. This will occur during general anaesthesia for a procedure that entails the performance of a radiograph (X-Ray) of the chest. The X-Ray will be used by the investigators to confirm correct placement of the temperature probe in the lower third of the oesophagus. We aim to show that the temperature measured in the lower oesophagus is the same or does not significantly differ from the temperature in the nasopharynx, even in the presence of a leak around the ETT. Temperature differences in degrees celsius will be reported.

Outcome measures

Outcome measures
Measure	Cuff Inflation and Cuff Deflation Groups n=50 Participants Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak
Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx	0.10 temperature difference degrees celsius Interval 0.04 to 0.16

SECONDARY outcome

Timeframe: 6 months

Sub-group analysis: Fractional Volume Loss (FVL) will be determined using spirometry readings taken during temperature measurements.

Outcome measures

Outcome data not reported

Adverse Events

Cuff Inflation and Cuff Deflation Groups

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cuff Inflation and Cuff Deflation Groups n=59 participants at risk Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak
Blood and lymphatic system disorders Nosebleed	1.7% 1/59
Respiratory, thoracic and mediastinal disorders Post-extubation stridor	1.7% 1/59
Respiratory, thoracic and mediastinal disorders Partially obstructed ETT during emergence	1.7% 1/59

Additional Information

Dr Emily Haberman

King's College Hospital NHS Foundation Trust

Phone: 07890549924

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place